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Latino immigrant men are at increased risk for unhealthy alcohol use and related consequences due to social stressors associated with immigration. We assessed the associations of, and examined whether social stressors moderated associations between, alcohol use and alcohol-related consequences in a community-based sample of Latino immigrant men in Washington (N = 187). The mean Alcohol Use Disorders Identification Test Consumption (AUDIT-C) score was 6.3 (scores ≥ 4 indicate unhealthy alcohol use). More than half of the men (61.5%) reported experiencing discrimination in at least one setting and mean acculturative stress score was 18.3 indicating moderate levels of acculturative stress. Linear regression models were fit to assess main effects (associations between both alcohol use and social stressors and alcohol-related consequences) and moderation (whether the association between alcohol use and consequences varied based on experience of social stressors using multiplicative interaction) after adjustment for potential confounders. Alcohol use (β = 0.47, 95% CI = 0.20-0.73; p =.001), discrimination (β = 0.85, 95% CI = 0.27-1.43; p =.004), and acculturative stress (β = 0.13, 95% CI = 0.02-0.24; p =.025) were all associated with increased experience of alcohol-related consequences. The association between alcohol use and alcohol-related consequences was stronger for those with high levels of acculturative stress (p =.025) but not experience of discrimination (p =.587). Findings underscore the importance of social and cultural context in alcohol use and related consequences. Efforts to reduce negative consequences of drinking may include focus on reducing exposure to discrimination and acculturative stress. [ABSTRACT FROM AUTHOR]

Highlights: Indigenous Peoples are concerned with previous experience of substance use research as disempowering.Community psychology principles may inform ethical community‐driven substance use research.We explore these principles through seven Indigenous substance use studies across the U.S. and Canada.Indigenous substance use research reflects, expands, and challenges community psychology principles.We discuss implications for Indigenous substance use research and community psychology. Many Indigenous communities are concerned with substance use (SU) problems and eager to advance effective solutions for their prevention and treatment. Yet these communities also are concerned about the perpetuation of colonizing, disorder‐focused, stigmatizing approaches to mental health, and social narratives related to SU problems. Foundational principles of community psychology—ecological perspectives, empowerment, sociocultural competence, community inclusion and partnership, and reflective practice—provide useful frameworks for informing ethical community‐based research pertaining to SU problems conducted with and by Indigenous communities. These principles are explored and extended for Indigenous community contexts through themes generated from seven collaborative studies focused on understanding, preventing, and treating SU problems. These studies are generated from research teams working with Indigenous communities across the United States and Canada—inclusive of urban, rural, and reservation/reserve populations as well as adult and youth participants. Shared themes indicate that Indigenous SU research reflects community psychology principles, as an outgrowth of research agendas and processes that are increasingly guided by Indigenous communities. At the same time, this research challenges these principles in important ways pertaining to Indigenous–settler relations and Indigenous‐specific considerations. We discuss these challenges and recommend greater synergy between community psychology and Indigenous research. [ABSTRACT FROM AUTHOR]

Substance use disorders (SUDs) are thought to predict care discontinuity, though magnitude and substance-specific variance of effects are unclear. This report of analytic work undertaken with a multi-regional American cohort of 9153 care enrollees addresses these gaps. Care retention was computed from 24-month post-linkage clinic visit documentation, with SUD cases identified from patient-report screening instruments. Two generalized estimating equations tested binary and hierarchial SUD predictors of retention, and potential effect modification by patient age-group, sex, and care site. Findings demonstrate: (1) detrimental SUD effect, equivalent to a nine percentage-point decrease in retention, with independent effects of age-group and care site; (2) substance-specific effect of marijuana UD associated with lower retention; and (3) age-modification of each effect on care discontinuity, with SUDs serving as a risk factor among 18–29 year-olds and protective factor among 60+ year-olds. Collective findings document patient attributes as influences that place particular subgroups at-risk to discontinue care. [ABSTRACT FROM AUTHOR]

Background and Aims In 2005 the American College of Surgeons passed a mandate requiring that level I trauma centers have mechanisms to identify and intervene with problem drinkers. The aim of this investigation was to determine if a multi-level trauma center intervention targeting both providers and patients would lead to higher-quality alcohol screening and brief intervention ( SBI) when compared with trauma center mandate compliance without implementation enhancements. Design Cluster randomized trial in which intervention site (site n = 10, patient n = 409) providers received 1-day workshop training on evidence-based motivational interviewing ( MI) alcohol interventions and four 30-minute feedback and coaching sessions; control sites (site n = 10, patient n = 469) implemented the mandate without study team training enhancements. Setting Trauma centers in the United States of America. Participants A total of 878 blood alcohol-positive in-patients with and without traumatic brain injury ( TBI). Measurements MI skills of providers were assessed with fidelity coded standardized patient interviews. All patients were interviewed at baseline and 6- and 12-months post-injury with the Alcohol Use Disorders Identification Test ( AUDIT). Findings Intervention site providers consistently demonstrated enhanced MI skills compared with control providers. Intervention patients demonstrated an 8% reduction in AUDIT hazardous drinking relative to controls over the course of the year after injury (relative risk = 0.88, 95%, confidence interval = 0.79, 0.98). Intervention patients were more likely to demonstrate improvements in alcohol use problems in the absence of traumatic brain injury (TBI) ( P = 0.002). Conclusion Trauma center providers can be trained to deliver higher-quality alcohol screening and brief intervention (SBI) than untrained providers, which is associated with modest reductions in alcohol use problems, particularly among patients without TBI. [ABSTRACT FROM AUTHOR]

The ultimate goal of alcohol treatment research is to develop interventions that help individuals reduce their alcohol use. To determine whether a treatment is effective, researchers must then evaluate whether a particular treatment affects changes in drinking behavior after treatment. Importantly, drinking following treatment tends to be highly variable between individuals and within individuals across time. Using data from the COMBINE study (), the current study compared 3 commonly used and novel methods for analyzing changes in drinking over time: latent growth curve (LGC) analysis, growth mixture models, and latent Markov models. Specifically, using self-reported drinking data from all participants ( n = 1,383, 69% male), we were interested in examining how well the 3 estimated models were able to explain observed changes in percent heavy drinking days during the 52 weeks following treatment. The results from all 3 models indicated that the majority of individuals were either abstinent or reported few heavy drinking days during the 52-week follow-up and only a minority of individuals (10% or fewer) reported consistently frequent heavy drinking following treatment. All 3 models provided a reasonably good fit to the observed data with the latent Markov models providing the closest fit. The observed drinking trajectories evinced discontinuity, whereby individuals seem to transition between drinking and nondrinking across adjacent follow-up assessment points. The LGC and growth mixture models both assumed continuous change and could not explain this discontinuity in the observed drinking trajectories, whereas the latent Markov approach explicitly modeled transitions between drinking states. The 3 models tested in the current study provided a unique look at the observed drinking among individuals who received treatment for alcohol dependence. Latent Markov modeling may be a highly desirable methodology for gaining a better sense of transitions between positive and negative drinking outcomes. [ABSTRACT FROM AUTHOR]

The article presents a study which examines the relationship of patient and clinician factors in the delivery of medical management intervention with treatment outcomes in patients participating in the National Institute on Alcohol Abuse and Alcoholism-sponsored COMBINE Study in the U.S. It was observed in the study that patients' positive perceptions of their alliance with clinician and their satisfaction with treatment was associated with more days of abstinence from alcohol during treatment.

Objective: The aim of this study was to examine the efficacy of pharmacological and behavioral interventions across 1 year posttreatment in the COMBINE (Combining Medications and Behavioral Interventions) Study. Method: Alcohol-dependent individuals (N = 1,383; 428 women) recruited at 11 outpatient academic alcoholism- treatment clinics across the United States participated in a randomized, double-blind, placebo-controlled trial. They received 16 weeks of naltrexone (Revia) or acamprosate (Campral) or both medications and/or placebos in combination with medical management (MM), with or without combined behavioral intervention (CBI); one group received CBI without pills or MM. Drinking behavior and clinical status were assessed at the end of treatment (Week 16) and at Weeks 26, 52, and 68. Results: Prior treatment with active naltrexone, without active acamprosate or CBI or with active acamprosate plus CBI, and CBI with double placebo resulted in a significantly higher percentage of days abstinent than double placebos with no CBI (p < .05). Having received CBI was associated with positive clinical response posttreatment, compared with not having received CBI. Prior treatment with naltrexone increased the time to the first heavy-drinking day posttreatment (p .03). No differences were found between patients who had received CBI without MM or pills and those having received MM and double placebo with or without CBI. No significant main effects for acamprosate were found on any of the outcome measures. Conclusions: Previous treatment with MM and either CBI or naltrexone, or both, but not acamprosate, was associated with sustained efficacy beyond discontinuation. Reasons for the maintained treatment gains with naltrexone and/or CBI and potential methods to extend them are discussed. [ABSTRACT FROM AUTHOR]

One area of intensive study in recent years in addiction research is the characterization and prediction of relapse risk. Given the growing list of findings and assessment tools in this area, in preparation for the second edition, revised volume of the Patient Placement Criteria (PPC) of the American Society of Addiction Medicine (ASAM), a workgroup of the Coalition for National Criteria was assigned the task of creating a revised conceptual organization for Dimension 5: Relapse/ Continued Use Potential. The workgroup conducted a review of the previous Dimension 5 constructs and criteria, including a decision analysis of the previous Dimension 5 decision rules. Following that analysis, field data from the ASAM Criteria Validity Study at Massachusetts General Hospital and Harvard Medical School were analyzed from a large cohort of public and indigent patients in eastern Massachusetts. After determining the concurrent validity of the Dimension 5 decision rules and their limitations, the decision rules were rewritten to gain improved validity. This exercise revealed techniques that can and should be used to improve the discrimination of levels of care among all Dimensions. Finally, the workgroup expanded and refined the constructs that should comprise a revised Dimension 5. This revised list of constructs is sequential and hierarchical. It offers face validity on several levels of current basic and clinical research knowledge: behavioral pharmacology, behavioral psychology, learning theory and psychopathology. While the Second Edition-Revised volume of the ASAM PPC (PPC-2R) does not go so far as to propose final decision rules for Dimension 5 based on these new constructs, it does recommend pilot adoption of several new assessment tools for this dimension and provides the framework incorporating those constructs and assessments in the next complete PPC edition. [ABSTRACT FROM AUTHOR]

Cites trauma centers as ideal sites for the implementation of an alcohol screening, intervention, and referral program in the United States. Attitude towards the effectiveness of alcohol treatment in trauma centers; Screening for alcohol problems in a trauma center.

ABSTRACT. Objective: The current study compared alcoholics who entered treatment for the first time with those who had reported one or more prior treatment experiences using a large sample (N = 1,362) of alcoholics who entered the National Institute on Alcohol Abuse and Alcoholism-sponsored COMBINE (Combining Medications and Behavioral Interventions) Study of pharmacological and behavioral treatment efficacy. Method: Participants were categorized into three prior-treatment groups: (I) treatment naive (n = 691, 50.73%), (2) one to two prior treatments (n 380, 27.90%), or (3) three or more prior treatments (n = 291, 21.37%). Groups were compared at baseline on multiple drinking and psychosocial variables. Results: The treatment-naive group was more likely to be female, educated, married, and employed. They reported the lowest levels of drinks per drinking day, average drinks per day, alcohol dependence, craving, and alcohol-related consequences; but, they had the oldest age at onset of alcohol problems. Both the treatment-naive group and the one-to-two prior-treatment group had lower percentage days abstinent within the prior 30 days, compared with the three-or-more group (22% and 25% vs 32%, respectively). The treatment-naive group reported the least commitment to an abstinence goal (43% vs 70% and 80%, respectively) and the lowest mean number of Alcoholics Anonymous meetings attended (0.86 vs 3.10 vs 6.91, respectively). They also reported fewer psychological symptoms, less distress, and higher levels of quality of life on physical, emotional, and environmental domains, as well as social relationships. Conclusions: Results suggest that a greater understanding of treatment-naive versus treatment-experienced clients may provide a better profile of help-seeking behavior and may suggest different approaches to treatment. [ABSTRACT FROM AUTHOR]

Abstract: The present study was designed to examine putative risk factors of driving anger, traffic citations, and traffic-related injuries as a function of gender. Participants included 785 (65% men) drivers identified by the Washington State Department of Licensing. Just over half of participants (55%) were identified as high-risk drivers based on multiple traffic violations, whereas 45% were recruited from a random sample of drivers. Participants completed a mailed survey assessing indicators of risky driving and risk factors including sensation seeking, stressful events, negative affect, tobacco use, and drinking behavior. Hierarchical regression analysis was used to evaluate risky driving outcomes as a function of theoretically prioritized risk factors and to evaluate gender as a moderator. Overall, men reported more traffic citations and injuries, but did not differ from women in reported driving anger. All putative risk factors were associated with one or more indicators of risky driving. Moderation results revealed that the positive relationship between drinking frequency and driving anger was stronger for women. In contrast, typical number of drinks consumed was negatively associated with driving anger, which was also more evident for women. In addition, the positive association between sensation seeking and number of traffic citations was stronger among women. [Copyright &y& Elsevier]

Background As marijuana legalization and acceptability increase in the U.S., it is important to understand the potential impact on tobacco use. Accordingly, we assessed prevalence, correlates, and ten-year trends in co-use of marijuana and tobacco among U.S. adults. Methods Data came from 378,459 adults participating in the 2003–2012 National Survey on Drug Use and Health, an annual, cross-sectional, household survey. Data from 2011–2012 were used to compute the most recent prevalence of past 30-day marijuana and tobacco use (co-use). Data from 2003–2012 were used to compute demographic correlates of co-use, overall trends in co-use, and trends by age, race, and sex. We also assessed trends in tobacco use among marijuana users and marijuana use among tobacco users. Results From 2011 to 2012, 5.2% of participants were past month co-marijuana and tobacco users, 24.0% were tobacco-only users, and 2.3% were marijuana-only users. From 2003 to 2012, prevalence of co-use increased overall (p < .0001), and among males and females (p < .001, p < .05), those ages 26–34 (p < .001) and 50 + years (p < .0001), and Whites (p < .01), Blacks (p < .05), and Hispanics (p < .01); there were no changes among adults 18–25 years. Tobacco use among marijuana users decreased between 2003 and 2012 (from 74.3% to 69.6%, p < .0001), while marijuana use increased among tobacco users (from 14.2% to 17.8, p < .0001). Conclusions Co-use of tobacco and marijuana increased from 2003–2012, with marijuana use increasing among past-month tobacco users and tobacco use declining among past-month marijuana users. Improved surveillance of co-use is needed as marijuana legalization policies expand and become more integrated in communities. [ABSTRACT FROM AUTHOR]

This study of persons referred to publicly funded drug-free substance abuse treatment in Washington State compares 122 primary heroin users (those specifying heroin as a drug of choice) with 532 persons who preferred other substances. Information on treatment entry and completion was obtained through review of client charts at the referral agency. Follow-up interviews with 587 participants provided self-reports of substance use during a 90-day period 3–6 months following removal from the treatment waitlist. Primary heroin users were significantly less likely than others to enter the treatment programs to which they were referred. Among treatment entrants, primary heroin users were somewhat less likely than other users to complete inpatient programs but no less likely to complete outpatient programs. The heroin preference group reported less abstinence and greater frequency of use during the follow-up period than did other users, patterns that almost entirely coincided with the lower treatment compliance in the heroin group. The authors note the importance of investigating methods for increasing treatment entry rates for opiate users who desire drug-free treatment. [Copyright &y& Elsevier]

The purpose of this study was to examine the association of acculturation with substance use treatment outcomes in a sample of treatment-seeking Latino/as (N = 405). The study used data from a multisite randomized controlled trial of a culturally adapted version of Motivational Enhancement Therapy delivered in Spanish. Berry, Kim, Minde, and Mok's (1987) acculturation model was used to divide the sample into 4 types (integrated, assimilated, separated, marginalized), based on Bicultural Involvement Questionnaire scores. One-way analyses of variance, chi-squared tests, and repeated-measures regression were used to examine baseline acculturation, posttreatment outcomes, and follow-up outcomes. All participants were of Latino/a background, and 88.4% of the sample was male. Participants with greater acculturation to American culture (i.e., integrated and assimilated acculturation types) reported more substance use and associated problems at baseline, χ²(3) = 20.5, p < .001, with the integrated type reporting the highest percentage of substance use disorder symptoms and problems (67.6%). No significant differences in substance use were detected among acculturation types posttreatment or at follow-up. Although the integrated and assimilated acculturation types were associated at baseline with more substance use and associated problems, all acculturation types seemed to benefit at posttreatment from an evidence-based culturally adapted treatment. (PsycINFO Database Record, ((c) 2017 APA, all rights reserved).)

We sought to examine behavioral health indicators for an early adolescent population of American Indians/Alaska Natives (AI/AN) within an urban setting in Washington State. We conducted secondary data analyses from a randomized clinical trial implemented in local middle schools that compared AI/ANs (n = 43), non-Hispanic Whites (n = 620), and other racial/ethnic minority youth (n = 527) across a variety of behavioral health risks. AI/AN youth reported significantly more depressive symptoms than other racial/ethnic minorities as well as non-Hispanic Whites. They also reported more discrimination, more generalized anxiety, and were more likely to have initiated substance use, in comparison to non-Hispanic Whites. Psychosocial screening and early intervention are critically needed for AI/AN youth.

This study examined whether level of exposure to Stimulant Abuser Groups to Engage in 12-Step (STAGE-12), a 12-Step facilitative therapy, is related to treatment outcome. Data were from a large National Drug Abuse Treatment Clinical Trials Network (CTN) study comparing STAGE-12 combined with treatment-as-usual (TAU) to TAU alone. These analyses include only those randomized to STAGE-12 (n=234). Assessments occurred at baseline and 30, 60, 90, and 180 days following randomization. High-exposure patients (n=158; attended at least 2 of 3 individual, and 3 of 5 group, sessions), compared to those with less exposure (n=76), demonstrated: (1) higher odds of self-reported abstinence from, and lower rates of, stimulant and non-stimulant drug use; (2) lower probabilities of stimulant-positive urines; (3) more days of attending and lower odds of not attending 12-Step meetings; (4) greater likelihood of reporting no drug problems; (5) more days of duties at meetings; and (6) more types of 12-Step activities. Many of these differences declined over time, but several were still significant by the last follow-up. Treatment and research implications are discussed., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: In 2005, the American College of Surgeons passed a mandate requiring that Level I trauma centers have a mechanism to identify patients who are problem drinkers and have the capacity to provide an intervention for patients who screen positive. The aim of the Disseminating Organizational Screening and Brief Intervention Services (DO-SBIS) cluster randomized trial is to test a multilevel intervention targeting the implementation of high-quality alcohol screening and brief intervention (SBI) services at trauma centers., Method: Twenty sites selected from all United States Level I trauma centers were randomized to participate in the trial. Intervention site providers receive a combination of workshop training in evidence-based motivational interviewing (MI) interventions and organizational development activities prior to conducting trauma-center-based alcohol SBI with blood-alcohol-positive injured patients. Control sites implement care as usual. Provider MI skills, patient alcohol consumption, and organizational acceptance of SBI implementation outcomes are assessed., Results: The investigation has successfully recruited provider, patient and trauma center staff samples into the study, and outcomes are being followed longitudinally., Conclusion: When completed, the DO-SBIS trial will inform future American College of Surgeons' policy targeting the sustained integration of high-quality alcohol SBI at trauma centers nationwide., (Published by Elsevier Inc.)

Aims: The study evaluated the effectiveness of an 8-week combined group plus individual 12-step facilitative intervention on stimulant drug use and 12-step meeting attendance and service., Design: Multisite randomized controlled trial, with assessments at baseline, mid-treatment, end of treatment, and 3- and 6-month post-randomization follow-ups (FUs)., Setting: Intensive outpatient substance treatment programs., Participants: Individuals with stimulant use disorders (n = 471) randomly assigned to treatment as usual (TAU) or TAU into which the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12) intervention was integrated., Measurements: Urinalysis and self-reports of substance use and 12-step attendance and activities., Intervention: Group sessions focused on increasing acceptance of 12-step principles; individual sessions incorporated an intensive referral procedure connecting participants to 12-step volunteers., Findings: Compared with TAU, STAGE-12 participants had significantly greater odds of self-reported stimulant abstinence during the active 8-week treatment phase; however, among those who had not achieved abstinence during this period, STAGE-12 participants had more days of use. STAGE-12 participants had lower Addiction Severity Index Drug Composite scores at and a significant reduction from baseline to the 3-month FU, attended 12-step meetings on a greater number of days during the early phase of active treatment, engaged in more other types of 12-step activities throughout the active treatment phase and the entire FU period, and had more days of self-reported service at meetings from mid-treatment through the 6-month FU., Conclusions: The present findings are mixed with respect to the impact of integrating the STAGE-12 intervention into intensive outpatient drug treatment compared with TAU on stimulant drug use. However, the results more clearly indicate that individuals in STAGE-12 had higher rates of 12-step meeting attendance and were engaged in more related activities throughout both the active treatment phase and the entire 6-month FU period than did those in TAU., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Screening, brief intervention, and referral to treatment (SBIRT) approaches to reducing hazardous alcohol and illicit drug use have been assessed in a variety of health care settings, including primary care, trauma centers, and emergency departments. A major methodological concern in these trials, however, is "assessment reactivity," the hypothesized impact of intensive research assessments to reduce alcohol and drug use and thus mask the purported efficacy of the interventions under scrutiny. Thus, it has been recommended that prospective research designs take assessment reactivity into account. The present article describes the design of the National Institute on Drug Abuse Clinical Trials Network protocol, Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED), which addresses the potential bias of assessment reactivity., Methods/design: The protocol employs a 3-arm design. Following an initial brief screening, individuals identified as positive cases are consented, asked to provide demographic and locator information, and randomly assigned to one of the three conditions: minimal screening only, screening + assessment, or screening + assessment + brief intervention. In a two-stage process, the randomization procedure first reveals whether or not the participant will be in the minimal-screening-only condition. Participants in the other two groups receive a more extensive baseline assessment before it is revealed whether they have been randomized to also receive a brief intervention. Comparing the screening only and screening + assessment conditions will allow determination of the incremental effect of assessment reactivity., Discussion: Assessment reactivity is a potential source of bias that may reduce and/or lead to an underestimation of the purported effectiveness of brief interventions. From a methodological perspective, it needs to be accounted for in research designs. The SMART-ED design offers an approach to minimize assessment reactivity as a potential source of bias. Elucidating the role of assessment reactivity may offer insights into the mechanisms underlying SBIRT as well as suggest clinical options incorporating assessment reactivity as a treatment adjunct. CLINICALTRIALS.GOV IDENTIFIER: NCT01207791.

Background: There is need to improve treatment effectiveness for stimulant misusers, and one means of doing so is by tailoring services to account for common diagnostic comorbidities and psychosocial challenges they face., Objectives: Using its publicly available datasets, this CTN-approved secondary analysis project examined prevalence of alcohol use disorders (AUDs) among primary stimulant misusing treatment-seekers as well as impact of AUD comorbidity on their pre-treatment psychosocial functioning., Methods: Upon identifying a primary stimulant misuser subsample (N = 1133) from among aggregated treatment-seekers across eight CTN trials, diagnostic data were used to document lifetime AUD rates. Paired comparisons, stratified by stimulant drug type (e.g., amphetamine, cocaine) then tested the influence of AUD comorbidity on psychosocial indices from the Addiction Severity Index - Lite., Results: A high AUD rate (45%) was found in this client population. Among primary cocaine misusers, those with AUD were more likely to: (i) show elevated Addiction Severity Index composite scores, (ii) perceive greater importance of drug treatment, and (iii) endorse psychiatric symptoms and perceived need for their treatment. Among primary amphetamine misusers, those with AUD were more likely to endorse specific psychiatric symptoms., Conclusion: Study findings document AUD comorbidity as a fairly common diagnostic feature of primary stimulant misusers, and suggest it is a pervasive influence on the pre-treatment psychosocial functioning of cocaine misusers., Scientific Significance: This study demonstrates the utility of CTN common assessment battery for secondary analysis projects, though challenges noted during its conduct highlight the value of consistent data collection and documentation within and across CTN trials.

Background: Bidirectional, collaborative partnerships between academic researchers and practitioners have been a fundamental vehicle to achieve the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) goal of improving outcomes of community-based drug treatment. These partnerships blend clinical perspectives of practitioners and methodological expertise of researchers working together to address clinically meaningful issues through randomized clinical trials conducted in community treatment settings., Objectives: Bidirectionality is a guiding principle of the CTN, but its operationlization at the practical level in protocol development and implementation has not been articulated. This descriptive article presents the development of one protocol as an example and model of this bidirectional, collaborative, iterative partnership between researchers and practitioners., Methods: This article illuminates several specific issues encountered while developing STAGE-12, a behavioral intervention to facilitate 12-step mutual support group involvement, as well as the rationale for decisions taken to resolve each., Results: The STAGE-12 protocol was successfully developed through a series of decisions taking into account both design factors and clinical practice needs and realities, thus maintaining a balance between methodological rigor and generalizability., Conclusion: The review demonstrates the process by which research and practice have been blended in protocol development, exemplifying the underlying principle of bidirectionality, a key element in the success of the NIDA CTN., Scientific Significance: Bidirectional partnerships as derived in the CTN, employing a hybrid model of efficacy-effectiveness research, are capable of designing and implementing protocols that are both methodologically rigorous and clinically meaningful, thus increasing likelihood of adoption and eventual improvement in public health.

Background: Medical settings such as emergency departments (EDs) present an opportunity to identify and provide services for individuals with substance use problems who might otherwise never receive any form of assessment, referral, or intervention. Although screening, brief intervention, and referral to treatment models have been extensively studied and are considered effective for individuals with alcohol problems presenting in EDs and other medical settings, the efficacy of such interventions has not been established for drug users presenting in EDs., Objectives: This article describes the design of a NIDA Clinical Trials Network protocol testing the efficacy of an screening, brief intervention, and referral to treatment model in medical EDs, highlighting considerations that are pertinent to the design of other studies targeting substance use behaviors in medical treatment settings., Methods: The protocol is described, and critical design decisions are discussed., Results: Design challenges included defining treatment conditions, study population, and site characteristics; developing the screening process; choosing the primary outcome; balancing brevity and comprehensiveness of assessment; and selecting the strategy for statistical analysis., Conclusion: Many of the issues arising in the design of this study will be relevant to future studies of interventions for addictions in medical settings., Scientific Significance: Optimal trial design is critical to determining how best to integrate substance abuse interventions into medical care.

Background: The importance of conducting substance use disorder treatment research in real-world settings is now well recognized. While this approach to clinical trials research offers a variety of benefits, challenges also arise. Selecting high-quality sites to participate is critical to recruitment, retention, and overall trial performance when conducting multi-site, community-based clinical trials of treatments for substance use disorders., Objectives: Over the past 10 years, the National Institute on Drug Abuse-sponsored National Drug Abuse Treatment Clinical Trials Network (CTN) has strived to conduct high-quality, well-managed clinical trials. This includes developing methods for site selection to be used by investigators conducting CTN trials., Methods: We review site selection strategies from two community-based multi-site clinical trials conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network., Results: Issues relevant to site selection include the clinical trial design, availability of appropriate clinical population, and organizational attributes of potential clinical research sites. Site selection strategies include reviewing regional epidemiologic data, collecting standard site selection surveys, evaluating clinic data on existing patient populations, and site selection interviews and visits., Conclusion: This article describes considerations for selecting research sites and identifies specific strategies to employ when selecting community-based sites for participation in clinical trials.

The National Drug Abuse Treatment Clinical Trials Network (CTN) began in 2000 with the goal of "improv[ing] the quality of drug abuse treatment throughout the country using science as the vehicle." Since then, 24 discrete clinical trials were launched, 20 are completed, and 15 have published main outcome papers. Of the latter, 4 tested pharmacological treatment, 8 psychosocial/behavioral treatment, 1 a combination of medication and counseling, and 2 targeted HIV/hepatitis C virus risk behavior. We review main study findings for these trials, including treatment retention, substance use or risk behavior outcomes, and secondary outcomes when analyzed. The purpose of this review is to identify the incremental progress toward improving drug treatment made by these trials and to propose next steps for the CTN and for the field arising from these studies. The CTN provides a unique opportunity to systematically design trials that incorporate treatment improvements from previous trials and to direct efforts toward innovations most likely to be incorporated into practice.