Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-04

Study Completion Date

2016-12-19

Brief Summary

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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.

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Detailed Description

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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

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Cannabis Dependence Alcohol Dependence Cannabis Use Disorder Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental: aprepitant 125 mg/day

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

Group Type ACTIVE_COMPARATOR

aprepitant

Intervention Type DRUG

125 mg daily for 8 weeks.

Manual-guided behavioral counseling

Intervention Type BEHAVIORAL

Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.

Placebo 125mg/d

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo daily for 8 weeks.

Manual-guided behavioral counseling

Intervention Type BEHAVIORAL

Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.

Interventions

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aprepitant

125 mg daily for 8 weeks.

Intervention Type DRUG

Placebo

Placebo daily for 8 weeks.

Intervention Type DRUG

Manual-guided behavioral counseling

Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.

Intervention Type BEHAVIORAL

Other Intervention Names

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Emend Manual-guided therapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No