NCT02210195

Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The Scripps Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cannabis Dependence
• Alcohol Dependence
• Cannabis Use Disorder
• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	aprepitant	125 mg daily for 8 weeks.
DRUG	Placebo	Placebo daily for 8 weeks.
BEHAVIORAL	Manual-guided behavioral counseling	Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.

Timeline

• Start date: 2014-09-04
• Primary completion: 2016-12-19
• Completion: 2016-12-19
• First posted: 2014-08-06
• Last updated: 2017-08-02
• Results posted: 2017-08-02

Locations

1 site across 1 country: United States