Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence

The Scripps Research Institute

Status and phase: Completed; Phase 2

Conditions: Cannabis Dependence; Cannabis Use Disorder; Alcohol Use Disorder; Alcohol Dependence

Treatments: Behavioral: Manual-guided behavioral counseling; Drug: aprepitant; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02210195

DA030988-04S1

R01DA030988-04S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females from 18-70 years of age
• Meets DSM IV criteria for current alcohol and cannabis dependence
• Seeking research-based outpatient treatment for alcohol and cannabis dependence that involves daily oral medication
• Negative BAC and a CIWA score < 9 at randomization

Exclusion criteria

• Significant medical disorders or use of medications that will increase potential risk or influence study outcomes
• Females who are pregnant, nursing or who are sexually active with child-bearing potential and refuse to use an effective, non hormonal method of birth control during the study and for up to 4 weeks after study termination• Treatment with an investigational drug during the previous month
• Prior treatment with NK1 antagonists
• Participants for whom treatment is being mandated by a legal authority• Inability to understand and/or comply with the provisions of the protocol and consent form

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Experimental: aprepitant 125 mg/day

Active Comparator group

Description:

125 mg aprepitant daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.

Treatment:

Drug: aprepitant

Behavioral: Manual-guided behavioral counseling

Placebo 125mg/d

Placebo Comparator group

Description:

Matched placebo pill given daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.

Treatment:

Drug: Placebo

Behavioral: Manual-guided behavioral counseling