Conditions: Cannabis Dependence Alcohol Dependence Cannabis Use Disorder Alcohol Use Disorder
Keywords: Cannabis Treatment Alcohol Treatment Alcohol-Related Disorders Cannabis-Related Disorders Substance-Related Disorders Emend NK1 receptor antagonist Alcohol Cannabis aprepitant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

Brief summary:
The primary aim of the supplemental study is to provide POC testing of aprepitant as a treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in the parent grant will likewise be applied to the supplemental project to test for effects of aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The primary hypothesis is that subjects treated with aprepitant will have significantly less alcohol and marijuana use than subjects treated with placebo.

Detailed description:
Consistent with the scope and methods of the parent grant, this was a randomized, double-blind, placebo-controlled, parallel groups, Phase II, single-site, 8-week clinical trial of aprepitant 125 mg/d or placebo. Participants were 20 outpatients seeking treatment for concurrent alcohol and cannabis dependence. All participants received weekly protocol-specific counseling. Research assessments occurred weekly through the treatment phase of the 8-week study. Post treatment follow-up assessments occurred at Weeks 9 and 12.

Arms:
arm 1: 125 mg aprepitant daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. arm 2: Matched placebo pill given daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.

Interventions: intervention 1: aprepitant intervention 2: Placebo intervention 3: Manual-guided behavioral counseling
Intervention descriptions: intervention 1: 125 mg daily for 8 weeks. intervention 2: Placebo daily for 8 weeks. intervention 3: Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.

Protocol document: