Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence

Alcohol Use Disorder Clinical Trial

Official title:

Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210195
• Other study ID #: DA030988-04S1
• Secondary ID: R01DA030988-04S1
• Status: Completed
• Phase: Phase 2
• First received: July 31, 2014
• Last updated: February 13, 2017
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: The Scripps Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Consistent with the scope and methods of the parent grant, this will be a randomized, double-blind, placebo-controlled, parallel groups, Phase II, single-site, 8-week clinical trial of aprepitant 125 mg/d or placebo. Participants will be 40 outpatients seeking treatment for concurrent alcohol and cannabis dependence. All participants will receive weekly protocol-specific counseling. Research assessments will occur weekly through the treatment phase of the 8-week study. Post treatment follow-up assessments will occur at Weeks 9 and 12.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcohol Use Disorder
• Alcoholism
• Cannabis Dependence
• Cannabis Use Disorder
• Disease
• Marijuana Abuse

Intervention

Drug:
• aprepitant
125 mg daily for 8 weeks.
• 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.

Locations

Country	Name	City	State
United States	The Scripps Research Institute	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
The Scripps Research Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marijuana	Marijuana Quantity and Frequency will be assessed using urinary 11-nor-9-carboxy-tetrahydrocannabinol (THCCOOH)	Participants will be followed for up to 12 weeks
Primary	Drinking	Drinking Quantity and Frequency will be assessed using the Timeline Followback Interview (TLFB).	Participants will be followed for up to 12 weeks