Continuing care for cocaine dependence: comprehensive 2-year outcomes.

This report presents 2-year outcome data from an outpatient continuing care study in which cocaine-dependent patients (N = 132) were randomly assigned to either standard group counseling (STND) or individualized relapse prevention (RP). Data on cocaine outcomes during the 6-month treatment phase of the study were presented in an earlier report (J. R. McKay, A. I. Alterman, J. S. Cacciola, M. R. Rutherford, & C. P. O'Brien, 1997). In the present report, a continuing care condition main effect was obtained on only 1 of 8 outcome variables examined. However, patients who endorsed a goal of absolute abstinence on entering continuing care had better cocaine use outcomes in RP than in STND, whereas the opposite was the case for those with less stringent abstinence goals. In addition, patients with current cocaine or alcohol dependence on entering continuing care who received RP had better cocaine use outcomes in Months 1-6 and better alcohol use outcomes in Months 13-24 than those in STND.     

Impact of psychosocial treatments on associated problems of cocaine-dependent patients.

A previous report from the National Institute on Drug Abuse Collaborative Cocaine Treatment Study (P. Crits-Christoph et al., 1999) found relatively superior cocaine and drug use outcomes for individual drug counseling plus group drug counseling compared with other treatments. Using data from that study, the authors examined the relative efficacy of 4 treatments for cocaine dependence on psychosocial and other addiction-associated problems. The 487 patients were randomly assigned to 6 months of treatment with cognitive therapy, supportive-expressive therapy, or individual drug counseling (each with additional group drug counseling), or to group drug counseling alone. Assessments were made at baseline and monthly for 6 months during the acute treatment phase, with follow-up visits at 9 and 12 months. No significant differences between treatments were found on measures of psychiatric symptoms, employment, medical, legal, family-social, interpersonal, or alcohol use problems. The authors concluded that the superiority of individual drug counseling in modifying cocaine use does not extend broadly to other addiction-associated problems.     

A randomized controlled trial of goal choice interventions for alcohol use disorders among men who have sex with men

This study tested the efficacy of behavioral treatments for alcohol use disorders (AUD) among men who have sex with men (MSM) and who are at risk for HIV transmission. HIV-negative MSM with current AUD (N = 198) were recruited, offered treatment focused on reducing drinking and HIV risk, and followed during treatment and 12 months posttreatment. Participants (n = 89) accepted treatment and were randomized to either 4 sessions of motivational interviewing (MI) or 12 sessions of combined MI and coping skills training (MI + CBT). Other participants (n = 109) declined treatment but were followed, forming a non-help-seeking group (NHS). MI yielded significantly better drinking outcomes during the 12-week treatment period than MI + CBT, but posttreatment outcomes were equivalent. NHS participants significantly reduced their drinking as well. Service delivery and treatment research implications are discussed.     

Mediators of outcome of psychosocial treatments for cocaine dependence

This study examined endorsement of 12-step philosophy and engagement in recommended 12-step activities as a mediator of the outcomes of individual plus group counseling for cocaine dependence. Assessments of drug use outcomes and the mediator were made at baseline and monthly for 6 months. Engagement in recommended 12-step activities was found to be a partial statistical mediator of drug use outcomes of individual (plus group) drug counseling, but no evidence for change in the mediator preceding change in drug use was found. In addition, a measure of beliefs about addiction developed to test mediation of outcome of cognitive therapy was found to correlate moderately with drug use outcomes in both cognitive therapy and individual drug counseling.     

Allelic and haplotypic association of GABRA2 with alcohol dependence.

Alcohol dependence is a highly prevalent disorder that is associated with serious morbidity and mortality. Because the GABAA neurotransmitter receptor is an important mediator for several behavioral effects of alcohol, genes encoding GABA-related proteins are functional candidates to influence risk of alcohol dependence. Two genome-wide scans showed linkage of alcohol dependence to a region on chromosome 4p, which contains a cluster of genes encoding GABAA receptor subunits. A recent effort to fine map that region showed a haplotypic association of alcohol dependence to the gene encoding the GABAA receptor alpha-2 subunit (GABRA2). We examined 10 single nucleotide polymorphisms (SNPs) spanning the coding region of this gene in samples of European American subjects with alcohol dependence (n = 446), and controls (n = 334) screened to exclude substance use disorders. There was evidence of association to alcohol dependence for seven adjacent markers spanning 98,000 bp in the middle and 3'-portion of the GABRA2 gene (range of P-values = 0.008-0.03). When the subset of the alcohol-dependent subjects excluding those with a diagnosis of cocaine or opioid dependence or major depressive episode (n = 198) was examined, the strength of the association was increased across these 7 SNPs (range of P-values = 0.002-0.007). Two common haplotypes in this region accounted for 90.8% of chromosomes. The more common haplotype was present in 55.6% of control group chromosomes versus 48.2% of alcohol-dependent subjects (P = 0.007) and 45.8% of subjects with alcohol dependence but no co-morbid drug dependence or depression (P = 0.003). These findings replicate and extend recently reported findings, which together underscore the potential contribution of polymorphic variation at the GABRA2 locus to the risk for alcohol dependence.     

Prospective association of childhood attention-deficit/hyperactivity disorder (ADHD) and substance use and abuse/dependence: a meta-analytic review

Given the clinical and public health significance of substance disorders and the need to identify their early risk factors, we examined the association of childhood attention-deficit/hyperactivity disorder (ADHD) with substance use (nicotine, alcohol, marijuana) and abuse/dependence outcomes (nicotine, alcohol, marijuana, cocaine, other). To strengthen a potential causal inference, we meta-analyzed longitudinal studies that prospectively followed children with and without ADHD into adolescence or adulthood. Children with ADHD were significantly more likely to have ever used nicotine and other substances, but not alcohol. Children with ADHD were also more likely to develop disorders of abuse/dependence for nicotine, alcohol, marijuana, cocaine, and other substances (i.e., unspecified). Sex, age, race, publication year, sample source, and version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) used to diagnose ADHD did not significantly moderate the associations with substance outcomes that yielded heterogeneous effect sizes. These findings suggest that children with ADHD are significantly more likely to develop substance use disorders than children without ADHD and that this increased risk is robust to demographic and methodological differences that varied across the studies. Finally, few studies addressed ADHD and comorbid disruptive behavior disorders (DBD), thus preventing a formal meta-analytic review. However, we qualitatively summarize the results of these studies and conclude that comorbid DBD complicates inferences about the specificity of ADHD effects on substance use outcomes.     

A Web-Based Self-Help Intervention With and Without Chat Counseling to Reduce Cannabis Use in Problematic Cannabis Users: Three-Arm Randomized Controlled Trial

BackgroundAfter alcohol and tobacco, cannabis is the most widely used psychoactive substance in many countries worldwide. Although approximately one in ten users develops serious problems of dependency, only a minority attend outpatient addiction counseling centers. A Web-based intervention could potentially reach those users who hesitate to approach such treatment centers.ObjectiveTo test the efficacy of a Web-based self-help intervention with and without chat counseling—Can Reduce—in reducing the cannabis use of problematic cannabis users as an alternative to outpatient treatment services.MethodsAltogether, 436 participants were recruited by various online and offline media for the Web-based trial. A total of 308 of these were eligible for study participation and were randomly allocated in an unblinded manner to either self-help with chat (n=114), self-help without chat (n=101), or a waiting list control group (n=93). The fully automated self-help intervention consisted of eight modules designed to reduce cannabis use, and was based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioral therapy. Additional individual chat counseling sessions were based on the same therapeutic principles. The sessions were conducted by trained counselors and addressed participants'' personal problems. The main outcomes were the frequency (number of days) and quantity of cannabis use (number of standardized joints) per week, as entered into the consumption diary at baseline and at the 3-month follow-up. Secondary outcomes included self-reported symptoms of cannabis use disorder, severity of cannabis dependence, risky alcohol use, and mental health symptoms. Intervention participation and retention were extracted from the user progress data and the consumption diary, respectively.ResultsCan Reduce participants were older (U=2.296, P=.02) and reported a greater number of cannabis use days at baseline than patients who entered outpatient treatment with cannabis as their main problem substance (data from the Swiss treatment demand monitoring statistics were used; chi-square [df 2]=4.0, P=.046). Participants in the self-help with chat study arm completed a mean of 3.2 modules and 27 out of 114 (23.7%) of the participants received at least one chat session. Participants in the self-help without chat study arm completed similar numbers of self-help modules. A total of 117 of 308 participants (38.0%) completed the 3-month follow-up assessment. The change in the mean number of cannabis use days per week at 3 months differed between self-help without chat (mean change 0.7, SD -0.2) and self-help with chat (mean change 1.4, SD -0.5; beta=-0.75, SE=0.32, t=-2.39, P=.02, d=0.34, 95% CI 0.07-0.61), as well as between self-help with chat and waiting list (mean change 1.0, SD -0.8; beta=0.70, SE=0.32, t=2.16, P=.03, d=0.20, 95% CI -0.07 to 0.47). However, there were no differences between self-help without chat and waiting list (beta=-0.05, SE=0.33, t=-0.16, P=.87, d=-0.14, 95% CI -0.43 to 0.14). Self-reported abstinence was significantly different in the self-help without chat study arm (2.0%) than in the self-help with chat study arm (8.8%; beta=-1.56, SE=0.79, P=.05, odds ratio [OR]=0.21, 95% CI 0.02-2.33). There were no significant differences between the study arms with respect to the secondary outcomes.ConclusionsWeb-based self-help interventions supplemented by brief chat counseling are an effective alternative to face-to-face treatment and can reach a group of cannabis users who differ in their use and sociodemographic characteristics from those who enter outpatient addiction treatment.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 59948178; http://www.isrctn.com/ISRCTN59948178 (Archived by WebCite at http://www.webcitation.org/6bt01gfIr)     

Alcoholics anonymous and relapse prevention as maintenance strategies after conjoint behavioral alcohol treatment for men: 18-month outcomes

Ninety men with alcohol problems and their female partners were randomly assigned to 1 of 3 outpatient conjoint treatments: alcohol behavioral couples therapy (ABCT), ABCT with relapse prevention techniques (RP/ABCT), or ABCT with interventions encouraging Alcoholics Anonymous (AA) involvement (AA/ABCT). Couples were followed for 18 months after treatment. Across the 3 treatments, drinkers who provided follow-up data maintained abstinence on almost 80% of days during follow-up, with no differences in drinking or marital happiness outcomes between groups. AA/ABCT participants attended AA meetings more often than ABCT or RP/ABCT participants, and their drinking outcomes were more strongly related to concurrent AA attendance. For the entire sample, AA attendance was positively related to abstinence during follow-up in both concurrent and time-lagged analyses. In the RP/ABCT treatment, attendance at posttreatment booster sessions was related to posttreatment abstinence. Across treatment conditions, marital happiness was related positively to abstinence in concurrent but not time-lagged analyses.     

Cerebrovascular complications of the use of the "crack" form of alkaloidal cocaine

BACKGROUND AND METHODS. The use of cocaine, especially one of its alkaloidal forms ("crack"), has been increasingly associated with cerebrovascular disease. To clarify the clinical, radiologic, and pathological features of the events associated with cocaine use, we identified 28 patients at four medical centers who had stroke temporally related to the use of alkaloidal cocaine (during or within 72 hours of use). RESULTS. The 28 patients had the following types of cerebrovascular event: cerebral infarction (n = 18 [2 hemorrhagic; 1 fatal]) in the areas supplied by the middle cerebral artery (n = 10), anterior cerebral artery (n = 3), posterior cerebral artery (n = 1), and vertebrobasilar arteries (n = 4); subarachnoid hemorrhage (n = 5); intraparenchymal hemorrhage (n = 4); and primary intraventricular hemorrhage (n = 1). Eighteen patients (64 percent) had acute neurologic symptoms immediately or within one hour of using cocaine. Fifteen patients (45 percent) with either occlusive or hemorrhagic strokes had sever headache as an early symptom. Vasculitis was not suggested by radiography in any patient, nor was it identified on pathological examination in one patient who died. All the patients were young (mean age, 34 years; range, 23 to 49) and had no other apparent, direct cause of stroke. Other risk factors for stroke among the patients included mild mitral-valve prolapse (n = 4), hypertension (n = 4), cigarette smoking (n = 8), and regular alcohol use (n = 6). CONCLUSIONS. There is a strong temporal association of the use of alkaloidal cocaine with both ischemic and hemorrhagic cerebrovascular events. Cocaine-related stroke probably has many causes. A thorough history focusing on the use of cocaine and toxicologic screening of urine and serum should be part of the evaluation of any young patient with a stroke.     

Behavioral couples therapy (BCT) for alcohol and drug use disorders: a meta-analysis

Narrative reviews conclude that behavioral couples therapy (BCT) produces better outcomes than individual-based treatment for alcoholism and drug abuse problems (e.g., [Epstein, E. E., & McCrady, B. S. (1998). Behavioral couples treatment of alcohol and drug use disorders: Current status and innovations. Clinical Psychology Review, 18(6), 689-711; O'Farrell, T. J., & Fals-Stewart, W. (2003). Alcohol abuse. Journal of Marital and Family Therapy, 29(1), 121-146]). However, the strength and consistency of this effect favoring BCT has not been examined because a meta-analysis of BCT studies has not been reported. This meta-analysis combines multiple well controlled studies to help clarify the overall impact of BCT in the treatment of substance use disorders. A comprehensive literature search produced 12 randomized controlled trials (n=754) that were included in the final analyses. There was a clear overall advantage of including BCT compared to individual-based treatments (Cohen's d=0.54). This was true across outcome domains (frequency of use d=0.36, consequences of use d=0.52, and relationship satisfaction d=0.57). However the pattern of results varied as a function of time. BCT was superior to control conditions only in relationship satisfaction at posttreatment (d=0.64). However, at follow-up BCT was superior on all three outcome domains (frequency of use d=0.45, consequences of use d=0.50, and relationship satisfaction d=0.51). In addition to other control conditions, BCT also outperformed individual cognitive behavioral therapy without couples therapy (d=0.42). Larger sample sizes were associated with higher effect sizes (p=0.02). However, treatment dose and publication year were not related to effect size. Overall, BCT shows better outcomes than more typical individual-based treatment for married or cohabiting individuals who seek help for alcohol dependence or drug dependence problems. The benefit for BCT with low severity problem drinkers has received little attention and one study suggests its efficacy may not extend to this subgroup.     

The role of homework in cognitive-behavioral therapy for cocaine dependence

This study examines the effect of homework compliance on treatment outcome in 123 participants receiving cognitive-behavioral therapy (CBT) for cocaine dependence. Regression analyses revealed a significant relationship between homework compliance and cocaine use that was moderated by readiness to change. Homework compliance predicted less cocaine use during treatment but only for participants higher in readiness to change. For those lower in readiness to change, homework compliance was not associated with cocaine use during treatment. Homework compliance early in therapy was associated with better retention in treatment. Homework compliance was not predicted by participants' level of education or readiness to change. These findings support the use of homework during CBT for substance use disorders.     

Lamotrigine for bipolar disorder and comorbid cocaine dependence: a replication and extension study

BACKGROUND: Bipolar disorder (BPD) is associated with high rates of substance abuse. We previously reported favorable results with lamotrigine in 30 patients with BPD and cocaine dependence. This report examines lamotrigine therapy in an additional 32 cocaine dependent patients. Data on these 32 participants are presented as a replication study. In addition, we extend the previous findings by combining data from both groups, and by exploring predictors of response. METHOD: Participants received a baseline evaluation and assessment for up to 36weeks with the 17-item Hamilton Rating Scale for Depression (HRSD(17)), Young Mania Rating Scale (YMRS), Brief Psychiatric Rating Scale (BPRS(18)), and Cocaine Craving Questionnaire (CCQ). Urine samples were obtained, and participants reported drug use during the previous week. RESULTS: In the replication sample (n=32), significant improvements were observed in HRSD(17), YMRS, BPRS(18), and CCQ (baseline to exit), as well as on dollars/week spent on cocaine. In the extension study, the original sample (n=30) and the replication sample (n=32) were combined for a total of 62 participants in the intent-to-treat sample. HRSD(17), YMRS, BPRS(18), and CCQ scores, as well as dollars spent on cocaine, decreased significantly. LIMITATIONS: The study has an open-label, uncontrolled design. CONCLUSION: Lamotrigine treatment was associated with significant improvements in mood, drug craving, and drug use. Controlled trials are needed.     

Problem-based learning outcomes: the glass half-full.

PURPOSE: To compare the characteristics and outcome data of students from a single institution with a two-track, problem based learning (PBL) and standard (STND) curriculum. METHOD: PBL and STND students from nine graduating classes at Southern Illinois University School of Medicine were compared using common medical school performance outcomes (USMLE Step 1, USMLE Step 2, clerkship mean ratings, number of clerkship honors and remediation designations, and the senior clinical competency exam), as well as common admission and demographic variables. RESULTS: PBL students were older, and the cohort had a higher proportion of women. The two tracks had similar USMLE Step 1 and 2 mean scores and pass rates. Performance differences were significant for PBL students in two clerkships as well as in the clerkship subcategories of clinical performance, knowledge and clinical reasoning, and noncognitive behaviors. In addition, the proportion of PBL students earning honors was greater. CONCLUSIONS: The traditional undergraduate educational outcomes for the PBL and STND students are very positive. In several of the clerkship performance measures, the PBL students performed significantly better, and in no circumstance did they perform worse than the STND students.     

Web-Based Cognitive Behavioral Self-Help Intervention to Reduce Cocaine Consumption in Problematic Cocaine Users: Randomized Controlled Trial

Background

Web-based self-help programs that reduce problematic substance use are able to reach hidden consumer groups in the general population. These programs are characterized by their low treatment threshold and nonrestrictive intervention settings. They are also cost effective, making them of interest to both low-income and high-income industrialized countries with ever-increasing health costs.

Objective

To test the feasibility and effectiveness of an anonymous, fully automated, Web-based self-help intervention as an alternative to outpatient treatment services for cocaine users.

Methods

A total of 196 cocaine-using participants were recruited through various online and offline media for a randomized controlled trial. Participants in the intervention group received interactive cognitive behavioral modules and a consumption diary to reduce cocaine use, whereas participants in the control group received online psychoeducative information modules. Web-based follow-up assessments were conducted after 4 weeks, 6 weeks, and 6 months. Treatment retention was examined and compared between the intervention and control groups. Severity of cocaine dependence was the main outcome measure. Secondary outcomes were cocaine craving, depression symptoms, and alcohol and other substance use.

Results

This Web-based intervention attracted older and more educated participants than existing outpatient treatment programs for which cocaine is the primary substance of abuse. Participants in the intervention group showed greater treatment retention compared with the control group (P = .04). Low response rates at the follow-up assessments restricted the explanatory power of the analyses. At the follow-up assessments, the severity of cocaine dependence did not differ between the intervention and control groups (P = .75). Furthermore, there were no differences in cocaine craving, depression, or alcohol and other substance use. Using the consumption diaries, the average number of cocaine-free days per week did not change significantly, whereas the weekly quantity of cocaine used decreased equally in both groups (P = .009).

Conclusions

For cocaine users with low dependence severity, a fully automated Web-based cognitive behavioral self-help intervention is a feasible alternative with limited effectiveness in outpatient treatment services. However, this type of intervention may attract specific user groups that are rarely reached by existing outpatient treatment and may help them to control their cocaine consumption anonymously.

Trial Registration

ISRCTN93702927; http://www.controlled-trials.com/ISRCTN93702927 (Archived by WebCite at http://www.webcitation.org/6CTMM10MR)     

Toward the DSM-V: the Withdrawal-Gate Model versus the DSM-IV in the diagnosis of alcohol abuse and dependence

The Diagtnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV; American Psychiatric Association, 1994) classifies as dependent many cases of mild alcohol problems. DSM-IV diagnoses have modest relationships with predictive and some concurrent validators and often improperly sequence the onset of abuse versus dependence, perhaps due to insufficient emphasis on physiological features. Testing reliability, syndrome prevalence, syndrome sequencing, and concurrent and predictive validity, this study contrasted the DSM-IV with the Withdrawal-Gate Model (WGM), in which alcohol withdrawal is necessary and sufficient for the dependence diagnosis. Clinical samples of adults (baseline n = 318) and adolescents (baseline n = 214) meeting abuse or dependence were assessed for DSM-IV alcohol symptoms and external measures of problem severity and reinterviewed at 6 (adults) and 12 months (adults and adolescents). Among DSM-IV dependent cases, the WGM shifted 32% of adults and 80% of adolescents to the abuse category, making both categories more symptomatically severe, but had a negligible effect on the prevalence of total alcohol diagnoses. The WGM was more reliable than the DSM-IV and temporally sequenced abuse before dependence in a greater number of cases. The WGM was superior to the DSM-IV in concurrent and predictive validity on most measures. Future diagnostic systems may be more reliable and valid if they require evidence of withdrawal for substance dependence.     

Personality traits and psychiatric comorbidities in alcohol dependence

Non-adaptive personality traits may constitute risk factors for development of psychiatric disorders such as depression and anxiety. We aim to evaluate associations and the predictive value of personality traits among alcohol-dependent individuals, with or without psychiatric comorbidities. The convenience sample comprised two groups of males over 18 years of age: one with subjects who had an alcohol dependence diagnosis (AG, n=110), and a control group without abuse and/or alcohol dependence diagnosis (CG, n=110). The groups were assessed by means of the Structured Clinical Interview DSM-IV (SCID-IV). AG participants were recruited among outpatients from the university hospital, whereas CG participants were recruited from a primary healthcare program. Data collection was done individually with self-assessment instruments. Parametric statistics were performed, and a significance level of P=0.05 was adopted. A positive correlation was observed between openness and the length of time that alcohol has been consumed, as were significant and negative correlations between conscientiousness and both the length of time alcohol has been consumed and the number of doses. For alcoholics, extraversion emerged as a protective factor against depression development (P=0.008) and tobacco abuse (P=0.007), whereas openness worked as a protective factor against anxiety (P=0.02). The findings point to specific deficits presented by alcoholics in relation to personality traits with or without psychiatric comorbidities and to the understanding that therapeutic approaches should favor procedures and/or preventive measures that allow more refined awareness about the disorder.     

Mediators of telephone-based continuing care for alcohol and cocaine dependence

A previous randomized trial with 224 alcohol and/or cocaine addicts who had completed an initial phase of treatment indicated that 12 weeks of telephone-based continuing care yielded higher abstinence rates over 24 months than did group counseling continuing care. The current study examined mediators of this treatment effect. Results suggested that self-help involvement during treatment and self-efficacy and commitment to abstinence 3 months after treatment mediated subsequent abstinence outcomes. These analyses controlled for substance use prior to the assessment of mediators. Conversely, there was no evidence that self-help beliefs or social support mediated the treatment effect. These results are consistent with a model in which treatment effects are first accounted for by changes in behavior, followed by changes in self-efficacy and in commitment to abstinence.     

A naturalistic study of the effects of pharmacotherapy on substance use disorders among ADHD adults

BACKGROUND: Studies of adults with attention deficit hyperactivity disorder (ADHD) show an elevated prevalence of substance use disorders (SUDs) and the substance abuse literature shows that ADHD is elevated in substance users. Some researchers postulate that stimulant treatment of ADHD increases the risk for SUD in ADHD patients but follow-up studies suggest treatment protects patients from subsequent SUDs. This report uses retrospective data to assess the impact of prior ADHD pharmacotherapy on SUDs in 206 ADHD adults (n=79 late-onset ADHD, n=127 full ADHD) grouped by lifetime history of ADHD treatment (no treatment, past treatment, current and past treatment). METHOD: Structured Clinical Interview for DSM-IV (SCID) data were used to establish abuse and dependence, and Drug Use Screening Inventory (DUSI) responses were used to establish prevalence of use, preference for cigarettes, alcohol and drugs of abuse, complications from use, and motivation for use (get high, change mood, sleep better). RESULTS: No differences were found in the prevalence of cigarette smoking, alcohol or drug abuse or dependence, as well as no significant differences in 1-month prevalence of any use or use more than 20 times. No differences were found in complications of drug or alcohol use across groups. Subjects with current treatment rated getting high as a motivating factor significantly more frequently than subjects in the past treatment group; this result lost significance when we included ADHD diagnostic category. CONCLUSIONS: Our results are consistent across substances and ADHD diagnoses, and support the hypothesis that pharmacotherapy does not cause subsequent SUDs.     

Brief cognitive counseling with HIV testing to reduce sexual risk among men who have sex with men: results from a randomized controlled trial using paraprofessional counselors

OBJECTIVES: To test the efficacy and acceptability of a single-session personalized cognitive counseling (PCC) intervention delivered by paraprofessionals during HIV voluntary counseling and testing. METHODS: HIV-negative men who have sex with men (MSM; n = 336) were randomly allocated to PCC or usual counseling (UC) between October 2002 and September 2004. The primary outcome was the number of episodes of unprotected anal intercourse (UAI) with any nonprimary partner of nonconcordant HIV serostatus in the preceding 90 days, measured at baseline, 6 months, and 12 months. Impact was assessed as "intent to treat" by random-intercept Poisson regression analysis. Acceptability was assessed by a standardized client satisfaction survey. RESULTS: Men receiving PCC and UC reported comparable levels of HIV nonconcordant UAI at baseline (mean episodes: 4.2 vs. 4.8, respectively; P = 0.151). UAI decreased by more than 60% to 1.9 episodes at 6 months in the PCC arm (P < 0.001 vs. baseline) but was unchanged at 4.3 episodes for the UC arm (P = 0.069 vs. baseline). At 6 months, men receiving PCC reported significantly less risk than those receiving UC (P = 0.029 for difference to PCC). Risk reduction in the PCC arm was sustained from 6 to 12 months at 1.9 (P = 0.181), whereas risk significantly decreased in the UC arm to 2.2 during this interval (P < 0.001 vs. 6 months; P = 0.756 vs. PCC at 12 months). Significantly more PCC participants were "very satisfied" with the counseling experience (78.2%) versus UC participants (59.2%) (P = 0.002). CONCLUSIONS: Both interventions were effective in reducing high-risk sexual behavior among MSM repeat testers. PCC participants demonstrated significant behavioral change more swiftly and reported a more satisfying counseling experience than UC participants.