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Objective: Few studies have examined the effectiveness of 12-step peer recovery support programs with drug use disorders, especially stimulant use, and it is difficult to know how outcomes related to 12-step attendance and participation generalize to individuals with non-alcohol substance use disorders (SUDs).Method: A clinical trial of 12-step facilitation (N=471) focusing on individuals with cocaine or methamphetamine use disorders allowed examination of four questions: Q1) To what extent do treatment-seeking stimulant users use 12-step programs and, which ones? Q2) Do factors previously found to predict 12-step participation among those with alcohol use disorders also predict participation among stimulant users? Q3) What specific baseline "12-step readiness" factors predict subsequent 12-step participation and attendance? And Q4) Does stimulant drug of choice differentially predict 12-step participation and attendance?Results: The four outcomes variables, attendance, speaking, duties at 12-step meetings, and other peer recovery support activities, were not related to baseline demographic or substance problem history or severity. Drug of choice was associated with differential days of Alcoholics Anonymous (AA) and Narcotics Anonymous (NA) attendance among those who reported attending, and cocaine users reported more days of attending AA or NA at 1-, 3- and 6-month follow-ups than did methamphetamine users. Pre-randomization measures of perceived benefit of 12-step groups predicted 12-step attendance at 3- and 6-month follow-ups. Pre-randomization 12-step attendance significantly predicted number of other self-help activities at end-of-treatment, 3- and 6-month follow-ups. Pre-randomization perceived benefit and problem severity both predicted number of self-help activities at end-of-treatment and 3-month follow-up. Pre-randomization perceived barriers to 12-step groups were negatively associated with self-help activities at end-of-treatment and 3-month follow-up. Whether or not one participated in any duties was predicted at all time points by pre-randomization involvement in self-help activities.Conclusions: The primary finding of this study is one of continuity: prior attendance and active involvement with 12-step programs were the main signs pointing to future involvement. Limitations and recommendations are discussed. [ABSTRACT FROM AUTHOR]

Introduction: High risk sex-such as sex with multiple partners, condomless sex, or transactional or commercial sex-is a risk factor in individuals with substance use disorders (SUDs). SUD treatment can reduce sexual risk behavior, but interventions to reduce such behavior in this context have not been consistently effective. This study sought to determine if the impact of treatment on sexual risk behavior can be increased.Methods: In a nested 2 × 2 factorial repeated measures design, we examined outcomes of two interventions: training for counselors in talking to patients about sexual risk; and availability to both counselors and patients of a personalized feedback report based on patient self-report of sexual behavior. Counselors received either a brief, information-based, Basic Training, or a multi-session, skills-based Enhanced Training. Their patients completed an audio-assisted computerized assessment of sexual behavior and received either No Feedback or a Personalized Feedback Report (PFR). Four hundred seventy six patients participated. Patient follow-up occurred 3- and 6-months postbaseline. Primary patient outcome measures were Number of Unsafe Sex Occasions (USO) and whether patients reported talking about sex in counseling sessions (Discussed Sex), both in the past 90 days. Secondary outcomes included Number of Sexual Partners, Sex Under the Influence of Substances, and Perceived Condom Barriers.Results: Patients of Enhanced-condition counselors compared to those of Basic-condition counselors were more likely to report talking about sex with their counselor at 6-month follow-up. Personalized feedback also increased the likelihood of reporting counselor discussions at 6-month follow-up. Neither the training nor the feedback condition affected USO, Number of Partners, or Sex Under the Influence.Discussion: We discuss why these two interventions apparently altered counselor-patient communication about sexual risk behavior without affecting the behavior itself. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to examine the implementation and acceptability of Mindful Awareness in Body-oriented Therapy (MABT), a novel adjunctive approach to substance use disorder (SUD) treatment. The primary aims of the study were to examine implementation of MABT as an adjunct to addiction treatment, and MABT acceptability to study participants and treatment staff. Methods: MABT was delivered to participants randomly assigned to the intervention in a larger ongoing trial. This study focuses only on the implementation and acceptability of the intervention, as outcomes are not yet available. MABT was delivered once weekly for 8 weeks (1.5-hour sessions) and spanned inpatient and outpatient programs at a women-only treatment facility. Descriptive statistics were used to examine participant recruitment and retention to the intervention. To measure MABT acceptability, survey and written questionnaires were administered; analysis involved descriptive statistics and content analysis using Atlas.ti software. Results: Thirty-one (31) of the women enrolled in the study were randomized to MABT. Eighteen (18) participants completed 75%-100% of the MABT sessions. Intervention implementation required flexibility on the part of both the researchers and the clinic staff, and minor changes were made to successfully implement MABT as an adjunct to usual care. MABT was perceived to increase emotional awareness and provide new tools to cope with stress, and to positively influence SUD treatment by facilitating emotion regulation. Conclusions: It was feasible to implement MABT and to recruit and retain women to MABT in women's chemical-dependency treatment. MABT acceptability and perceived benefit was high. [ABSTRACT FROM AUTHOR]

Abstract: Biologically targeted agents offer the promise of delivering specific anticancer effects while limiting damage to healthy tissue, including the central and peripheral nervous systems. During the past 5-10 years, these agents were examined in preclinical and adult clinical trials, and are used with increasing frequency in children with cancer. This review evaluates current knowledge about neurotoxicity from biologically targeted anticancer agents, particularly those in pediatric clinical trials. For each drug, neurotoxicity data are reviewed in adult (particularly studies of brain tumors) and pediatric studies when available. Overall, these agents are well tolerated, with few serious neurotoxic effects. Data from younger patients are limited, and more neurotoxicity may occur in the pediatric population because these agents target pathways that control not only tumorigenesis but also neural maturation. Further investigation is needed into long-term neurologic effects, particularly in children. [Copyright &y& Elsevier]

ABSTRACT Aims Clinical trials test the safety and efficacy of behavioral and pharmacological interventions in drug-dependent individuals. However, there is no consensus about the most appropriate outcome(s) to consider in determining treatment efficacy or on the most appropriate methods for assessing selected outcome(s). We summarize the discussion and recommendations of treatment and research experts, convened by the US National Institute on Drug Abuse, to select appropriate primary outcomes for drug dependence treatment clinical trials, and in particular the feasibility of selecting a common outcome to be included in all or most trials. Methods A brief history of outcomes employed in prior drug dependence treatment research, incorporating perspectives from tobacco and alcohol research, is included. The relative merits and limitations of focusing on drug-taking behavior, as measured by self-report and qualitative or quantitative biological markers, are evaluated. Results Drug-taking behavior, measured ideally by a combination of self-report and biological indicators, is seen as the most appropriate proximal primary outcome in drug dependence treatment clinical trials. Conclusions We conclude that the most appropriate outcome will vary as a function of salient variables inherent in the clinical trial, such as the type of intervention, its target, treatment goals (e.g. abstinence or reduction of use) and the perspective being taken (e.g. researcher, clinical program, patient, society). It is recommended that a decision process, based on such trial variables, be developed to guide the selection of primary and secondary outcomes as well as the methods to assess them. [ABSTRACT FROM AUTHOR]

Background: The first 10 years of the National Institute on Drug Abuse's Clinical Trials Network (CTN) yielded a wealth of data on the effectiveness of a number of behavioral, pharmacological, and combined approaches in community-based settings. Methods: We summarize some of the methodological contributions and lessons learned from the behavioral trials conducted during its first ten years, including the capacity and enormous potential of this national research infrastructure. Results: The CTN made contributions to the methodology of effectiveness research; new insights from secondary analyses; the extent to which approaches with strong evidence bases, such as contingency management, extend their effectiveness to real world clinical settings; new data on 'standard treatment' as actually practiced in community programs, the extent to which retention remains a major issue in the field; important data on the safety of specific behavioral therapies for addiction; and heightened the importance of continued sustained attention to bridging the gap between treatment and research. Conclusions: Areas of focus for the CTN's future include defining common outcome measures to be used in treatment outcome studies for illicit drugs; incorporating performance indicators and measures of clinical significance; conducting comparative outcome studies; contributing to the understanding of effective treatments of comorbidity; reaching underserved populations; building implementation science; understanding long-term outcomes of current treatments and sustaining treatment effects; and conducting future trials more efficiently. [ABSTRACT FROM AUTHOR]

Women in drug treatment struggle with co-occurring problems, including trauma and post-traumatic stress disorder (PTSD), which can heighten HIV risk. This study examines the impact of two group therapy interventions on reduction of unprotected sexual occasions (USO) among women with substance use disorders (SUD) and PTSD. Participants were 346 women recruited from and receiving treatment at six community-based drug treatment programs participating in NIDA’s Clinical Trials Network. Participants were randomized to receive 12-sessions of either seeking safety (SS), a cognitive behavioral intervention for women with PTSD and SUD, or women’s health education (WHE), an attention control psychoeducational group. Participants receiving SS who were at higher sexual risk (i.e., at least 12 USO per month) significantly reduced the number of USO over 12-month follow up compared to WHE. High risk women with co-occurring PTSD and addiction may benefit from treatment addressing coping skills and trauma to reduce HIV risk. [ABSTRACT FROM AUTHOR]

Abstract: Few empirical studies are available to guide best practices for transferring evidenced-based treatments to community substance abuse providers. To maximize the learning and maintenance of new clinical skills, this study tested a context-tailored training (CTT) model, which used standardized patient actors in role-plays tailored to agency clinical context, repetitive cycles of practice and feedback, and enhanced organizational support. This study reports the results of a randomized pilot evaluation of CTT for motivational interviewing (MI). Investigators randomly assigned community substance abuse treatment agencies to receive either CTT or a standard 2-day MI workshop. The study also evaluated the effects of counselor-level and organizational-level variables on the learning of MI. No between-condition differences were observed on the acquisition and maintenance of MI skills despite reported higher satisfaction with the more costly context-tailored model. Analyses revealed that those counselors with more formal education and less endorsement of a disease model of addiction made the greatest gains in MI skills, irrespective of training condition. Similarly, agencies whose individual counselors viewed their organization as being more open to change and less supportive of autonomy showed greater average staff gains in MI skills, again, irrespective of training method. Posttraining activities within agencies that supported the ongoing learning and implementation of MI mediated the effects of organizational openness to change. This pilot study suggests that tailored training methods may not produce better outcomes than traditional workshops for the acquisition of evidence-based practice, and that efforts to enhance skill acquisition can be focused on characteristics of learners and ongoing organizational support of learning. [Copyright &y& Elsevier]

The authors compared the effectiveness of the Seeking Safety group, cognitive-behavioral treatment for substance use disorder and posttraumatic stress disorder (PTSD), to an active comparison health education group (Women's Health Education [WHE]) within the National Institute on Drug Abuse's Clinical Trials Network. The authors randomized 353 women to receive 12 sessions of Seeking Safety (M = 6.2 sessions) or WHE (M = 6.0 sessions) with follow-up assessment I week and 3, 6, and 12 months posttreatment. Primary outcomes were the Clinician Administered PTSD Scale (CAPS), the PTSD Symptom Scale-Self Report (PSS-SR), and a substance use inventory (self-reported abstinence and percentage of days of use over 7 days). Intention-to-treat analysis showed large, clinically significant reductions in CAPS and PSS-SR symptoms (d = 1.94 and 1.12, respectively) but no reliable difference between conditions. Substance use outcomes were not significantly different over time between the two treatments and at follow-up showed no significant change from baseline. Study results do not favor Seeking Safety over WHE as an adjunct to substance use disorder treatment for women with PTSD and reflect considerable opportunity to improve clinical outcomes in community-based treatments for these co-occurring conditions. [ABSTRACT FROM AUTHOR]

Abstract: 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. [Copyright &y& Elsevier]