A multisite, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of vigabatrin for treating cocaine dependence.

IMPORTANCE: Cocaine dependence is a significant public health problem, yet no validated pharmacological treatment exists. The potent γ-aminobutyric acid (GABA)ergic medication vigabatrin has previously been shown to be effective in a double-blind single-site study conducted in Mexico. OBJECTIVE: To evaluate the safety and efficacy of vigabatrin for the treatment of cocaine dependence in a U.S. sample. DESIGN AND SETTING: Multisite, randomized, double-blind, placebo-controlled, 12-week clinical trial with follow-up visits at weeks 13, 16, 20, and 24 in 11 U.S. sites. PARTICIPANTS: In total, 186 treatment-seeking participants with cocaine dependence (mean age, 45 years). Approximately 67% were male, and about 60% were of African American race/ethnicity. INTERVENTIONS: Participants received twice-daily doses of vigabatrin (total dosage, 3.0 g/d) or matched placebo, plus weekly computerized cognitive behavioral therapy and biweekly individual counseling for 13 weeks. Contingency management encouraged the provision of urine samples. MAIN OUTCOMES AND MEASURES: The primary outcome measure was the proportion of participants with cocaine abstinence during the last 2 weeks of the 12-week treatment phase as assessed by self-reports and quantitative urine drug screens. The weekly fraction of cocaine use days and the number of drug-free urine samples during weeks 1 through 13 were key secondary measures. RESULTS: No significant differences were observed between the vigabatrin group and the placebo group on the primary outcome measure (P = .67), key secondary measures (P > .99), or other outcome measures. However, while pill counts and self-reports indicated that more than 66% of all participants (and >63% of the vigabatrin group) took more than 70% of their medication, post hoc vigabatrin urine concentration levels suggested that approximately 40% to 60% of patients taking vigabatrin may not have been adherent. This lack of adherence may have obscured any evidence of vigabatrin efficacy. No visual acuity or visual field deterioration occurred in any of the participants. CONCLUSIONS AND RELEVANCE: No protocol-defined differences in efficacy between vigabatrin treatment and placebo were detected for any outcome variable. This may have been due to medication nonadherence or, alternatively, due to the weak efficacy of vigabatrin. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00611130.

The Substance Abuse Treatment Workforce of South Africa.

The purpose of this paper is to describe characteristics of substance abuse treatment counselors in the Republic of South Africa, including demographics, education, training, and job duties. Counselors recruited from 24 treatment centers completed a survey after signing informed consent. Counselors were primarily female (75%), racially diverse (36.4% White, 30.8% Black, 18.9% Coloured, 12.6% Indian or Asian, and 1.4% Cape Malay), and were 38 years old on average. The majority (62.3%) held at least an equivalent of a bachelor's degree, and just under half (49%) were registered social workers. Counselors had a mean of 5.3 years' experience in substance abuse treatment. The substance abuse treatment workforce of South Africa appears to be young and educated, yet only one third of the counselors had any formal training in Cognitive Behavioral Therapy. South African counselors could benefit from more training in evidence-based techniques.

HIV prevention among incarcerated male adolescents in an alternative school setting.

This pilot project tested the feasibility of an evidence-based HIV Intervention Program (HIP) program among 64 male youth, most of whom were African American or Hispanic, in Los Angeles County probation camps. Comparisons were made between adolescents who participated in HIP and a control group on changes in (a) condom use, (b) sexual intercourse under the influence of drugs, (c) knowledge of HIV prevention behaviors, and (d) attitudes toward condom use. Compared to the control group, the intervention group demonstrated significant increases in condom use and significant decreases in their endorsement of the attitude, ''If you want to use a condom, your boy-friend or girlfriend might think you don't trust them.'' These preliminary findings suggest that the HIP program influences key HIV-related constructs among male juvenile offenders.

African-American clergy's perceptions of the leading health problems in their communities and their role in supporting parishioners' health.

This article is a report on a survey of Southern California pastors to learn of their perceptions of the leading health problems in their congregations. Participants (N=41) identified stress, overweight, and obesity as the top three health indicators that effect the health of their congregations. Tobacco use and substance abuse were listed among the top five. From a list of health problems, pastors felt that from the pulpit they could impact parishioners responsible sexual behavior most. Pastors expressed their opinions about the reasons for certain maladies and addictions. The findings indicate room for improvement in building clergy's understanding of the nature of illness and addiction and in empowering them in their role of supporting healthy behaviors in the African-American community.

Randomized controlled pilot trial of cabergoline, hydergine and levodopa/carbidopa: Los Angeles Cocaine Rapid Efficacy Screening Trial (CREST).

AIM: This study tested three dopaminergic medications against a common unmatched placebo condition: hydergine 1 mg three times daily (n = 15); levodopa/carbidopa 25/100 mg three times daily (n = 15); cabergoline 0.5 mg per week (n = 15); and placebo three times daily (n = 15) as potential pharmacotherapies for cocaine dependence. DESIGN: The four-parallel group, Cocaine Rapid Efficacy Screening Trial (CREST) design featured a 2-week baseline period followed by randomization to an 8-week medication condition that included 1 hour per week of cognitive behavioral drug counseling. A safety evaluation was conducted 4 weeks after termination. MEASURES: Outcomes included cocaine metabolites measured in urine, retention and self-reports for drug use, cocaine craving, clinical improvement, mood and HIV risk behaviors. RESULTS: Participants assigned to receive cabergoline provided more urine samples negative for cocaine metabolites (42.4%) than those assigned to receive placebo (25.0%), a statistically significant difference after controlling for baseline differences in self-reported cocaine use (F = 2.95, df = 3; P = 0.05). Cabergoline-treated participants demonstrated a significant improvement over placebo from baseline to week 8 when measured using the Addiction Severity Index (ASI) employment subscale (overall change = - 0.09, SD = 0.10, t = 2.36, P < 0.05). Safety and adverse event measures showed similar rates and types of complaints by treatment condition. CONCLUSIONS: These results, combined with the apparent safety of cabergoline when used with this population, provide empirical support for conducting a larger study of the medication.