OBJECTIVE: Patients entering treatment for alcohol problems do not have uniform treatment goals, and a pretreatment drinking goal has a significant impact on treatment outcome. The objective of this study was to understand better how an array of individual characteristics, including factors that affect treatment, are related to treatment goals before beginning alcohol treatment in the COMBINE (Combining Medications and Behavioral Interventions) Study. METHOD: Participants were alcohol-dependent individuals (N = 1,156; 357 women) recruited at 11 outpatient academic alcoholism-treatment clinics across the United States to participate in a randomized, double-blind, placebo-controlled trial that combined behavioral intervention with acamprosate and/or naltrexone. Treatment goal was coded as controlled drinking, conditional abstinence, or total abstinence. Multinomial logistic regressions assessed whether there were significant relationships between predictor variables and pretreatment goal selection. RESULTS: Lower levels of alcohol-related consequences, lower readiness to change, higher family income, more daily drinkers in social network, and lack of prior treatment or Alcoholics Anonymous engagement predicted choice of a controlled drinking goal over a total abstinence goal. Fewer alcohol-related consequences, lower readiness to change, and more daily drinkers in-network predicted choice of a conditional abstinence goal over a total abstinence goal. CONCLUSIONS: Higher levels of functioning, lower levels of consequences, no prior involvement in treatment and Alcoholics Anonymous, and a more drinking-saturated social environment are associated with the choice of a non-abstinence goal.

Objective

Patients entering treatment for alcohol problems do not have uniform treatment goals, and a pretreatment drinking goal has a significant impact on treatment outcome. The objective of this study was to understand better how an array of individual characteristics, including factors that affect treatment, are related to treatment goals before beginning alcohol treatment in the COMBINE (Combining Medications and Behavioral Interventions) Study.

Method

Participants were alcohol-dependent individuals (N = 1,156; 357 women) recruited at 11 outpatient academic alcoholism-treatment clinics across the United States to participate in a randomized, double-blind, placebo-controlled trial that combined behavioral intervention with acamprosate and/or naltrexone. Treatment goal was coded as controlled drinking, conditional abstinence, or total abstinence. Multinomial logistic regressions assessed whether there were significant relationships between predictor variables and pretreatment goal selection.

Results

Lower levels of alcohol-related consequences, lower readiness to change, higher family income, more daily drinkers in social network, and lack of prior treatment or Alcoholics Anonymous engagement predicted choice of a controlled drinking goal over a total abstinence goal. Fewer alcohol-related consequences, lower readiness to change, and more daily drinkers in-network predicted choice of a conditional abstinence goal over a total abstinence goal.

Conclusions

Higher levels of functioning, lower levels of consequences, no prior involvement in treatment and Alcoholics Anonymous, and a more drinking-saturated social environment are associated with the choice of a non-abstinence goal.

Background

Several single-site alcohol treatment clinical trials have demonstrated efficacy for immediate-release (IR) gabapentin in reducing drinking outcomes among individuals with alcohol dependence. The purpose of this study was to conduct a large, multisite clinical trial of gabapentin enacarbil extended-release (GE-XR) (HORIZANT^® ), a gabapentin prodrug formulation, to determine its safety and efficacy in treating alcohol use disorder (AUD).

Methods

Men and women (n = 346) who met DSM-5 criteria for at least moderate AUD were recruited across 10 U.S. clinical sites. Participants received double-blind GE-XR (600 mg twice a day) or placebo and a computerized behavioral intervention (Take Control) for 6 months. Efficacy analyses were prespecified for the last 4 weeks of the treatment period.

Results

The GE-XR and placebo groups did not differ significantly on the primary outcome measure, percentage of subjects with no heavy drinking days (28.3 vs. 21.5, respectively, p = 0.157). Similarly, no clinical benefit was found for other drinking measures (percent subjects abstinent, percent days abstinent, percent heavy drinking days, drinks per week, drinks per drinking day), alcohol craving, alcohol-related consequences, sleep problems, smoking, and depression/anxiety symptoms. Common side-effects were fatigue, dizziness, and somnolence. A population pharmacokinetics analysis revealed that patients had lower gabapentin exposure levels compared with those in other studies using a similar dose but for other indications.

Conclusions

Overall, GE-XR at 600 mg twice a day did not reduce alcohol consumption or craving in individuals with AUD. It is possible that, unlike the IR formulation of gabapentin, which showed efficacy in smaller Phase 2 trials at a higher dose, GE-XR is not effective in treating AUD, at least not at doses approved by the U.S. Food and Drug Administration for treating other medical conditions.