Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence

July 5, 2017 updated by: Barbara J. Mason, The Scripps Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • The Scripps Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Experimental: aprepitant 125 mg/day
125 mg aprepitant daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
Drug: aprepitant
125 mg daily for 8 weeks.
Other Names:
  • Emend
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.
Other Names:
  • Manual-guided therapy
Placebo Comparator: Placebo 125mg/d
Matched placebo pill given daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
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.
Other Names:
  • Manual-guided therapy
Drug: Placebo
Placebo daily for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8
Time Frame: Week 0 and Week 8
Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).
Week 0 and Week 8
Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8
Time Frame: Week 0 and Week 8
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 8 - Week 0). More negative values indicate less use of alcohol.
Week 0 and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Scripps Research Institute

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2014

Primary Completion (Actual)

December 19, 2016

Study Completion (Actual)

December 19, 2016

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 6, 2014

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA030988-04S1
  • R01DA030988-04S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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