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Background Despite harmful drinking causing a significant burden on global health, there is a large treatment gap, especially in low- and middle-income countries. A major barrier to care is the lack of adequately skilled human resources to deliver contextually appropriate treatments. This paper describes the systematic process used to develop Counselling for Alcohol Problems ( CAP), a brief psychological treatment (PT) for delivery by lay counselors in routine primary care settings to men with harmful drinking in India. Methods CAP was developed using a methodology involving 3 sequential steps: (i) identifying potential treatment strategies; (ii) developing a theoretical framework for the treatment; and (iii) evaluating the acceptability and feasibility of the treatment. Results CAP is a 3-phase treatment delivered over 1 to 4 sessions based on a motivational interviewing ( MI) stance and involves the following strategies: assessment and personalized feedback, family engagement, drink refusal skills, skills to address drinking urges, problem-solving skills and handling difficult emotions, and relapse prevention and management. Data from a case series were used to inform several adaptations to enhance the acceptability of CAP to the recipients and feasibility of delivery by lay counselors of the treatment, for example expansion of the target group to include alcohol-dependent patients and the extension of the delivery settings to include home-based delivery. There was preliminary evidence of the effectiveness of CAP. Conclusions CAP is an acceptable brief PT for harmful drinking delivered by lay counselors in primary care whose effectiveness is currently being tested in a randomized controlled trial based in primary care in Goa, India. [ABSTRACT FROM AUTHOR]

Background: Computer‐based delivery of cognitive behavioral therapy (CBT) may be a less costly approach to increase dissemination and implementation of evidence‐based treatments for alcohol use disorder (AUD). However, comprehensive evaluations of costs, cost‐effectiveness, and cost–benefit of computer‐delivered interventions are rare. Methods: This study used data from a completed randomized clinical trial to evaluate the cost‐effectiveness and cost–benefit of a computer‐based version of CBT (CBT4CBT) for AUD. Sixty‐three participants were randomized to receive one of the following treatments at an outpatient treatment facility and attended at least one session: (1) treatment as usual (TAU), (2) CBT4CBT plus treatment as usual (CBT4CBT+TAU), or (3) CBT4CBT plus brief monitoring. Results: Median protocol treatment costs per participant differed significantly between conditions, Kruskal‐Wallis H(2) = 8.40, p = 0.02, such that CBT4CBT+TAU and CBT4CBT+monitoring each cost significantly more per participant than TAU. However, when nonprotocol treatment costs were included, total treatment costs per participant did not differ significantly between conditions. Median incremental cost‐effective ratios (ICERs) revealed that CBT4CBT+TAU was more costly and more effective than TAU. It cost $35.08 to add CBT4CBT to TAU to produce a reduction of one additional drinking day per month between baseline and the end of the 8‐week treatment protocol: CBT4CBT+monitoring cost $33.70 less to produce a reduction of one additional drinking day per month because CBT4CBT+monitoring was less costly than TAU and more effective at treatment termination, though not significantly so. Net benefit analyses suggested that costs of treatment, regardless of condition, did not offset monthly costs related to healthcare utilization, criminal justice involvement, and employment disruption between baseline and 6‐month follow‐up. Benefit–cost ratios were similar for each condition. Conclusions: Results of this pilot economic evaluation suggest that an 8‐week course of CBT4CBT may be a cost‐effective addition and potential alternative to standard outpatient treatment for AUD. Additional research is needed to generate conclusions about the cost–benefit of providing CBT4CBT to treatment‐seeking individuals participating in standard outpatient treatment. [ABSTRACT FROM AUTHOR]

Background: Acetaldehyde is causally related to head and neck cancer. Individuals with aldehyde dehydrogenase 2 deficiency experience alcohol sensitivity and are referred to as "flushers" because of their skin‐flushing response to high blood acetaldehyde levels after alcohol consumption. Acetaldehyde is produced in the oral cavity after local alcohol exposure without alcohol ingestion. However, the relationship between the oral acetaldehyde level after local alcohol exposure and alcohol sensitivity is unclear. Herein, sampling the exhaled breath, we evaluated the effect of alcohol sensitivity on the pharmacokinetics of ethanol (EtOH) and acetaldehyde in breath after mouth washing with alcohol. Methods: Twenty‐eight healthy young adults were divided into flusher and nonflusher groups based on an EtOH patch test. The subjects washed their mouths for 30 seconds with 40 ml of 5% v/v alcohol, and their breath samples were collected 12 times over 20 minutes after mouth washing and rinsing with water. EtOH and acetaldehyde concentrations in all breath samples were measured using sensor gas chromatography. Results: Breath EtOH concentrations exponentially decreased in both groups after mouth washing with alcohol. Breath acetaldehyde concentrations showed an immediate increase, followed by an almost exponential decrease in both groups, but concentrations in the flusher group remained higher than those in the nonflusher group throughout the 20‐minute measurement period. This was reflected in a peak concentration (Cmax) of 808 ± 70 parts‐per‐billion (ppb) versus 1,715 ± 223 ppb, respectively (p = 0.001), and area under the curve values of 3,528 ± 1,399 ppb minutes versus 8,637 ± 1,293 ppb minutes, respectively (p = 0.002). Conclusions: This study revealed high concentrations of acetaldehyde in breath after local alcohol exposure in the oral cavity among flushers even without alcohol ingestion. This contributes to an increased risk among flushers of mutagenic DNA lesions in the mucosa of the upper digestive tract and cancer. We evaluated the effect of alcohol sensitivity on the pharmacokinetics of ethanol and acetaldehyde in breath after mouth washing with alcohol. Breath acetaldehyde concentrations in the flusher group remained higher than those in the non‐flusher group throughout the measurement period. The results revealed high concentrations of breath acetaldehyde after local alcohol exposure in the oral cavity among flushers even without alcohol ingestion, which contributes to an increased risk among flushers of mutagenic DNA lesions in the mucosa of the upper digestive tract and cancer. [ABSTRACT FROM AUTHOR]

Background Aspects of impulsivity have been implicated in the development, or maintenance, of alcohol use disorder ( AUD). The brain dopamine system is implicated in both reward processing/memory (typically subcortical) and in brain inhibitory control mechanisms (typically cortical). Using a validated clinical laboratory paradigm, the dopamine/serotonin 'stabilizing' drug, aripiprazole was evaluated in non-treatment-seeking AUD individuals based on their level of impulsivity/self-control. Methods Ninety-nine individuals (77% male; mean age 27; 7.5 drinks per day; 83% heavy drinking days) meeting DSM- IV criteria for alcohol dependence were randomized to aripiprazole ( N = 47 evaluable) or placebo ( N = 48 evaluable) based on their Barratt Impulsiveness Scale ( BIS-11) score (above or below 68). Aripiprazole, or similar placebo, was titrated to 15 mg over 8 days. Drinking was recorded over 6 days under natural conditions. On Day 8, after 1 day of required abstinence, individuals participated in a bar laboratory paradigm that included a priming drink (breath alcohol concentration [ BAC] target 0.02 to 0.03 g/dl) and free-choice consumption of up to 8 drinks (max BAC 0.1 g/dl) in exchange for a 'bar credit' of $2 per drink (max $16). End points were drinks per day under natural conditions and drinks consumed in the bar laboratory after the priming drink. Results There was no significant main effect of aripiprazole or interaction with BIS-11 score during the natural drinking period. However, there was a main effect of aripiprazole on bar laboratory drinking ( p = 0.04) and aripiprazole reduced the total number of drinks consumed more among individuals with low self-control ( p = 0.034) and increased latency to consume those drinks ( p = 0.045) more among those with high impulsivity. Relative to placebo, aripiprazole caused more side effects and increased alcohol-induced sedation, but neither significantly influenced its interaction with impulsivity/self-control scores on drinking. Conclusions This paradigm forced a choice between immediate drinking reward and delayed monetary reward. In those with high impulsivity and/or low self-control, aripiprazole shifts the balance away from immediate drinking toward a later reward. Medications targeting cortical dopamine/serotonin balance might show clinical benefit of reduced drinking, among individuals with impulsivity/low self-control. [ABSTRACT FROM AUTHOR]

Background Treatment for alcohol use disorders (AUDs) has traditionally been abstinence oriented, but new research and regulatory guidelines suggest that low-risk drinking may also be an acceptable treatment outcome. However, little is known about long-term outcomes for patients who become low-risk drinkers posttreatment. This study explores a posttreatment low-risk drinking outcome as a predictor of future drinking and psychosocial outcomes over 9 years. Methods Study participants were adults with AUDs at treatment entry who received follow-up interviews 6 months posttreatment intake ( N = 1,061) in 2 large randomized studies conducted at Kaiser Permanente Northern California, a large private, nonprofit, integrated health system. Six-month drinking status was defined as abstinent, low-risk (nonabstinent, no 5+ drinking days), or heavy drinking (1 or more days of 5+ drinks). Using logistic regression models, we explored the relationship between past 30-day drinking status at 6 months and odds of being abstinent or a low-risk drinker (compared to heavy drinking), and positive Addiction Severity Index psychosocial outcomes over 9 years (9-year follow-up rate of 73%). Results Abstainers and low-risk drinkers at 6 months had higher odds of recent abstinence/low-risk drinking over 9 years than heavy drinkers; abstainers had better drinking outcomes than low-risk drinkers. Additionally, among those with interview data, 95% of abstainers and 94% of low-risk drinkers at 6 months were abstinent/low-risk drinkers at 9 years; surprisingly, 89% of heavy drinkers at 6 months were also abstinent/low-risk drinkers although still significantly fewer than the other groups. Abstainers and low-risk drinkers at 6 months had better psychiatric outcomes, and abstainers had better family/social outcomes than heavy drinkers; medical outcomes did not differ. Low-risk drinkers and abstainers showed no reliable differences across psychosocial measures. Conclusions The findings suggest that a low-risk drinking outcome may be reasonable over the long-term for some alcohol-dependent individuals receiving addiction treatment. [ABSTRACT FROM AUTHOR]

Background Standardized alcohol craving scales are rarely used outside of research environments despite recognized clinical utility. Scale length is a key barrier to more widespread application. A brief measure of alcohol craving is needed to improve research and treatment of alcohol use disorders ( AUDs). Grounded in the Elaborated Intrusion Theory of Desire, the Alcohol Craving Experience ( ACE) Questionnaire comprises two 11-item self-report scales that assess past-week frequency and maximum strength of alcohol craving. This study aimed to create a brief version of the ACE while maintaining psychometric integrity and clinical utility. Methods Patients attending a university hospital alcohol and drug outpatient service for the treatment of AUD completed the ACE as part of a questionnaire battery. Three patient samples were utilized: 519 patients with pretreatment and outcome data, 228 patients with pretreatment data, and 66 patients who completed the ACE at treatment sessions 1 and 2. Results The Frequency scale of the ACE possessed greater clinical utility and predictive validity than the Strength scale. Revision of the Frequency measure produced a 5-item 'Mini Alcohol Craving Experience' ( MACE) Questionnaire. Satisfactory validity (construct, predictive, concurrent, convergent, and incremental) and reliability (internal and test-retest) were maintained. A 1 standard deviation increase in pretreatment MACE score was associated with a 54 percentage increase in the odds of patient lapse or dropout. Conclusions The MACE provides a brief, theoretically, and psychometrically robust measure of alcohol craving suitable for use with AUD populations in time-limited clinical and research settings. [ABSTRACT FROM AUTHOR]

Background The construct of relapse is used widely in clinical research and practice of alcohol use disorder (AUD) treatment. The purpose of this study was to test the predictive validity of commonly appearing definitions of AUD relapse in the empirical literature. Methods Secondary analyses of data from Project MATCH and COMBINE were conducted using 7 definitions of 'relapse' based on drinking quantity within a single drinking episode: any drinking; at least 4/5 drinks for women/men; at least 4.3/7.1 drinks for women/men; at least 6/7 drinks for women/men; at least 6 drinks; at least 7/9 drinks for women/men; and at least 8/10 drinks for women/men. Relapse was used to predict alcohol consumption, related consequences, and nonconsumption outcomes (quality of life, psychosocial functioning) at the end of treatment and up to 1 year posttreatment. Results Regression analyses indicated within-treatment relapse definitions significantly predicted end-of-treatment alcohol consumption and alcohol-related consequences. Heavy drinking definitions were generally more predictive than the any drinking definition, but no single heavy drinking definition was consistently a better predictor of outcomes. Relapse definitions were less predictive of longer-term alcohol-related outcomes and both shorter- and longer-term nonconsumption outcomes, including health and psychosocial functioning. Conclusions One particular definition of relapse did not consistently stand out as the best predictor. Advances in AUD research may require reconceptualization of relapse as a multifaceted dynamic process and may consider a wider range of relevant behaviors (e.g., health and psychosocial functioning) when examining the change process in individuals with AUD. [ABSTRACT FROM AUTHOR]

Background Relapse is common in alcohol-dependent individuals and can be triggered by alcohol-related cues in the environment. It has been suggested that these individuals develop cognitive biases, in which cues automatically capture attention and elicit an approach action tendency that promotes alcohol seeking. The study aim was to examine whether cognitive bias modification ( CBM) training targeting approach bias could be delivered during residential alcohol detoxification and improve treatment outcomes. Methods Using a 2-group parallel-block (ratio 1:1) randomized controlled trial with allocation concealed to the outcome assessor, 83 alcohol-dependent inpatients received either 4 sessions of CBM training where participants were implicitly trained to make avoidance movements in response to pictures of alcoholic beverages and approach movements in response to pictures of nonalcoholic beverages, or 4 sessions of sham training (controls) delivered over 4 consecutive days during the 7-day detoxification program. The primary outcome measure was continuous abstinence at 2 weeks postdischarge. Secondary outcomes included time to relapse, frequency and quantity of alcohol consumption, and craving. Outcomes were assessed in a telephonic follow-up interview. Results Seventy-one (85%) participants were successfully followed up, of whom 61 completed all 4 training sessions. With an intention-to-treat approach, there was a trend for higher abstinence rates in the CBM group relative to controls (69 vs. 47%, p = 0.07); however, a per-protocol analysis revealed significantly higher abstinence rates among participants completing 4 sessions of CBM relative to controls (75 vs. 45%, p = 0.02). Craving score, time to relapse, mean drinking days, and mean standard drinks per drinking day did not differ significantly between the groups. Conclusions This is the first trial demonstrating the feasibility of CBM delivered during alcohol detoxification and supports earlier research suggesting it may be a useful, low-cost adjunctive treatment to improve treatment outcomes for alcohol-dependent patients. [ABSTRACT FROM AUTHOR]

Background Quantifying craving longitudinally during the course of withdrawal, early abstinence, and relapse is essential for optimal management of alcohol use disorder ( AUD). In an effort to identify biological correlates of craving, we used proton magnetic resonance spectroscopy (1H- MRS) to investigate the correlation between craving and glutamate levels in the left dorsolateral prefrontal cortex ( LDLPFC) of patients with AUD. Methods Participants underwent 1H- MRS of the LDLPFC with 2-dimensional J-resolved (2 DJ) averaged PRESS. MRS data were processed with LCModel and cerebrospinal fluid ( CSF)-corrected to generate metabolite concentrations. The Penn Alcohol Craving Scale ( PACS) and the 30-day time line follow-back ( TLFB 30) were used to quantify craving for alcohol and drinking patterns, respectively. Results There was a statistically significant positive correlation between CSF-corrected glutamate ([Glu]) levels and PACS scores ( n = 14; p = 0.005). When PACS scores were dichotomized (< or ≥median = 16), [Glu] levels were significantly higher in the high- versus low-craving group ( p = 0.007). In addition, there was a significant negative correlation between CSF-corrected N-acetyl aspartic acid ([ NAA]) levels and mean number of drinks per drinking day in the past month ( n = 13; TLFB 30; p = 0.012). When mean TLFB 30 was dichotomized (< or ≥median = 7.86), [ NAA] levels were significantly lower in subjects that consumed more alcoholic beverages. There was no significant correlation between [Glu] and [ NAA] levels with other measures of drinking behavior and or depression symptom severity. Conclusions While limited by small sample size, these data suggest that glutamate levels in LDLPFC are associated with alcohol craving intensity in patients with AUD. Further study with larger sample size is needed to replicate this finding and evaluate the merits of glutamate spectroscopy as a biological correlate of alcohol craving intensity and a guide to treatment interventions. [ABSTRACT FROM AUTHOR]

Background In clinical practice as well as research situations, it is of great importance to get reliable information about a patient's alcohol consumption. The aim of the study was to investigate the correlation of alcohol biomarkers (phosphatidylethanol [PEth], carbohydrate-deficient transferrin [ CDT], γ-glutamyltransferase, aspartate aminotransferase, and alanine aminotransferase) to retrospective as well as diary-based alcohol self-reports and to examine whether it is possible to correlate a biomarker result to a more precise level of alcohol consumption. Methods One hundred and sixty alcohol-dependent patients were included in a randomized, placebo-controlled clinical trial of pharmacotherapy for alcohol dependence, of which 115 (76 men and 39 women) completed the study. Retrospective alcohol consumption data were collected at baseline, and alcohol diaries were used during the study. Blood samples for determination of alcohol biomarkers were collected on 5 occasions during the study. Results PEth and CDT showed a better correlation with alcohol consumption documented in the diary ( PEth rs = 0.56 and CDT rs = 0.35) than with retrospective consumption data ( PEth rs = 0.23 and CDT rs = 0.22). An even higher correlation ( rs = 0.63) was seen between the 2 alcohol biomarkers PEth and CDT. At all consumption levels, PEth had the highest sensitivity of all biomarkers studied. Conclusions PEth was the biomarker with the best correlation to self-reported alcohol consumption. PEth was superior to CDT owing to its substantially higher sensitivity but also due to its closer correlation to self-report. PEth values can be translated into an approximate level of alcohol consumption and PEth appears to be a more reliable measure of alcohol consumption than self-reports. [ABSTRACT FROM AUTHOR]

Background Cognitive behavioral therapy-based alcohol treatment programs have been widely used to break the link between alcohol and crime. While evidence exists on the connection between alcohol and crime, there is little data that demonstrate the effectiveness of different alcohol treatment programs in reducing criminal behavior. We tested whether male offenders who participate in alcohol treatment programs show lower rates of recidivism than a matched offender group who did not participate in an alcohol prevention program. Methods This is an observational matched case-control study. Participants were 564 male offenders with an alcohol problem related to offending. Participants were assigned by the courts to 1 of 3 alcohol treatment programs (141 offenders per treatment): Low Intensity Alcohol Program ( LIAP), Alcohol Specified Activity Requirement, and Addressing Substance- Related Offending. A fourth matched group ( n = 141) was not assigned to a program and served as a control group. Survival analysis was used to calculate participants' charged and reconviction rates over 4 time periods (0 to 3, 4 to 6, 7 to 9, and 10 to 12 months after completion of program or order). Results Offenders who did not participate in a program were more than twice as likely to be charged compared to offenders who participated in a program. Furthermore, offenders who did not participate in a program were over 2.5 times more likely to be reconvicted. Among the 3 alcohol treatment programs evaluated, the LIAP was the most cost-effective. Conclusions Offenders enrolled in an alcohol treatment program showed a significant reduction in being charged with or reconvicted of a crime. With costs of keeping offenders in prison per year reaching close to £40,000 per offender per year (Mulheirn et al., 2010, ), assigning offenders to alcohol preventive programs-such as LIAP-are a promising way to reduce recidivism and reduce cost. [ABSTRACT FROM AUTHOR]

Background Posttraumatic stress disorder ( PTSD) and alcohol dependence ( AD) commonly co-occur and are associated with greater symptom severity and costs than either disorder alone. No pharmacologic interventions have been found to decrease both alcohol use and PTSD symptom severity relative to matched placebo. Prazosin, an alpha-1 adrenoreceptor antagonist, has demonstrated the efficacy of reducing PTSD and AD symptoms among individuals with one or the other disorder and may be useful in addressing comorbid PTSD/ AD. Methods Prazosin and matched placebo were compared in the context of an outpatient 6-week double-blind randomized controlled pilot trial involving 30 individuals with comorbid PTSD/ AD. Medication was titrated to 4 mg q am, 4 mg q pm and 8 mg qhs by the end of week 2. Participants in both conditions received 5 medical management sessions. Information regarding alcohol use, craving, and PTSD was gathered daily using a telephone interactive voice response system. Results Participants randomized to prazosin had a greater reduction in percent days drinking per week and percent days heavy drinking per week between baseline and week 6 than did placebo participants. No significant differences were detected within or between groups in change from weeks 1 to 6 in total PTSD symptoms. Participants in the prazosin condition reported drowsiness on significantly more days than those in the placebo condition. Conclusions Consistent with the extant research evaluating medications for comorbid PTSD/ AD, the current evaluation of prazosin also found decreased alcohol consumption but no medication effect on PTSD symptomatology. [ABSTRACT FROM AUTHOR]

Background Empirical literature indicates that the therapeutic alliance explains a modest but reliable proportion of variance in predicting alcohol-related outcomes among individuals in treatment for alcohol use disorders ( AUDs). Hartzler and colleagues (2011) showed in the COMBINE data set that alcohol abstinence self-efficacy is a potentially important statistical mediator of the relationship between the alliance and client outcomes. Methods The purpose of this study was to replicate this finding in the Project MATCH data set. We used total alliance ratings on the Working Alliance Inventory and tested both client and therapist ratings in mediation analyses. Results We found that posttreatment self-efficacy accounted for the effect of therapist and client ratings of alliance (measured at session 2) on posttreatment drinking outcomes (drinks per drinking day and alcohol-related problems). In addition, we found a moderation effect of treatment, such that the association between the client's rating of the alliance and self-efficacy changes was positive for individuals in the cognitive behavioral treatment group but negative for those receiving motivation enhancement or Twelve-Step Facilitation. Conclusions This study reaffirms the importance of the therapeutic alliance and self-efficacy in predicting AUD outcomes. Future research should examine changes in the therapeutic alliance throughout treatment and how these changes are related to self-efficacy and AUD treatment outcomes over time. [ABSTRACT FROM AUTHOR]

Background Attrition is common in alcohol clinical trials and the resultant loss of data represents an important methodological problem. In the absence of a simulation study, the drinking outcomes among those who are lost to follow-up are not known. Individuals who drop out of treatment and continue to provide drinking data, however, may be a reasonable proxy group for making inferences about the drinking outcomes of those lost to follow-up. Methods We used data from the COMBINE study, a multisite, randomized clinical trial, to examine drinking during the 4 months of treatment among individuals who dropped out of treatment but continued to provide drinking data (i.e., 'treatment dropouts;' n = 185). First, we estimated the observed treatment effect size for naltrexone versus placebo in a sample that included both treatment completers ( n = 961) and treatment dropouts ( n = 185; total N = 1,146), as well as the observed treatment effect size among just those who dropped out of treatment ( n = 185). In both the total sample ( N = 1,146) and the dropout sample ( n = 185), we then deleted the drinking data after treatment dropout from those 185 individuals to simulate missing data. Using the deleted data sets, we then estimated the effect of naltrexone on the continuous outcome percent heavy drinking days using 6 methods to handle missing data (last observation carried forward, baseline observation carried forward, placebo mean imputation, missing = heavy drinking days, multiple imputation ( MI), and full information maximum likelihood [ FIML]). Results MI and FIML produced effect size estimates that were most similar to the true effects observed in the full data set in all analyses, while missing = heavy drinking days performed the worst. Conclusions Although missing drinking data should be avoided whenever possible, MI and FIML yield the best estimates of the treatment effect for a continuous outcome measure of heavy drinking when there is dropout in an alcohol clinical trial. [ABSTRACT FROM AUTHOR]

Background: Relatively few studies have examined gender differences in the effectiveness of specific behavioral or pharmacologic treatment of alcohol dependence. The aim of this study is to assess whether there were gender differences in treatment outcomes for specific behavioral and medication treatments singly or in combination by conducting a secondary analysis of public access data from the national, multisite NIAAA-sponsored COMBINE study. Methods: The COMBINE study investigated alcohol treatment among 8 groups of patients (378 women, 848 men) who received medical management (MM) with 16 weeks of placebo, naltrexone (100 mg/day), acamprosate (3 g/day), or their combination with or without a specialist-delivered combined behavioral intervention. We examined efficacy measures separately for men and women, followed by an overall analysis that included gender and its interaction with treatment condition in the analyses. These analyses were performed to confirm whether the findings reported in the parent trial were also relevant to women, and to more closely examine secondary outcome variables that were not analyzed previously for gender effects. Results: Compared to men, women reported a later age of onset of alcohol dependence by approximately 3 years, were significantly less likely to have had previous alcohol treatment, and drank fewer drinks per drinking day. Otherwise, there were no baseline gender differences in drinking measures. Outcome analyses of 2 primary (percent days abstinent and time to first heavy drinking day) and 2 secondary (good clinical response and percent heavy drinking days) drinking measures yielded the same overall pattern in each gender as that observed in the parent COMBINE study report. That is, only the naltrexone by behavioral intervention interaction reached or approached significance in women as well as in men. There was a naltrexone main effect that was significant in both men and women in reduction in alcohol craving scores with naltrexone-treated subjects reporting lower craving than placebo-treated subjects. Conclusions: This gender-focused analysis found that alcohol-dependent women responded to naltrexone with COMBINE's Medical Management, similar to the alcohol-dependent men, on a wide range of outcome measures. These results suggest that clinicians can feel comfortable prescribing naltrexone for alcohol dependence in both men and women. In this study, it is also notable that fewer women than men reported receiving any alcohol treatment prior to entry into the COMBINE study. Of note, women tend to go to primary health care more frequently than to specialty substance abuse programs for treatment, and so the benefit we confirm for women of the naltrexone and MM combination has practical implications for treating alcohol-dependent women. [ABSTRACT FROM AUTHOR]