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Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by The Scripps Research Institute
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier:
NCT02210195
First received: July 31, 2014
Last updated: April 12, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Cannabis Dependence
Alcohol Dependence
Cannabis Use Disorder
Alcohol Use Disorder
Drug: aprepitant
Drug: Placebo
Behavioral: Manual-guided behavioral counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence

Resource links provided by NLM:


Further study details as provided by The Scripps Research Institute:

Primary Outcome Measures:
  • Marijuana [ Time Frame: Participants will be followed for up to 12 weeks ] [ Designated as safety issue: No ]
    Marijuana Quantity and Frequency will be assessed using urinary 11-nor-9-carboxy-tetrahydrocannabinol (THCCOOH)

  • Drinking [ Time Frame: Participants will be followed for up to 12 weeks ] [ Designated as safety issue: No ]
    Drinking Quantity and Frequency will be assessed using the Timeline Followback Interview (TLFB).


Estimated Enrollment: 40
Study Start Date: July 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.
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.
Other Name: Manual-guided therapy

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02210195

Contacts
Contact: Nicholas J Chesher, Ph.D. 858-784-7465 nchesher@scripps.edu

Locations
United States, California
The Scripps Research Institute Recruiting
La Jolla, California, United States, 92037
Contact: Nicholas J Chesher, Ph.D.    858-784-7465    nchesher@scripps.edu   
Principal Investigator: Barbara J. Mason, Ph.D.         
Sponsors and Collaborators
The Scripps Research Institute
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Barbara J. Mason, Ph.D. The Scripps Research Institute
  More Information

Responsible Party: Barbara J. Mason, Principal Investigator, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT02210195     History of Changes
Other Study ID Numbers: DA030988-04S1  R01DA030988-04S1 
Study First Received: July 31, 2014
Last Updated: April 12, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by The Scripps Research Institute:
Cannabis Treatment
Alcohol Treatment
Alcohol-Related Disorders
Cannabis-Related Disorders
Substance-Related Disorders
Emend
NK1 receptor antagonist
Alcohol
Cannabis
aprepitant

Additional relevant MeSH terms:
Disease
Marijuana Abuse
Alcoholism
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol-Related Disorders
Ethanol
Aprepitant
Fosaprepitant
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016