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Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence

This study has been completed.
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: July 5, 2017
Last verified: July 2017
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Barbara J. Mason, The Scripps Research Institute:

Primary Outcome Measures:
  • 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).

  • 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.


Enrollment: 20
Actual Study Start Date: September 4, 2014
Study Completion Date: December 19, 2016
Primary Completion Date: December 19, 2016 (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 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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, California
The Scripps Research Institute
La Jolla, California, United States, 92037
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 ( U.S. NIH Grant/Contract )
Study First Received: July 31, 2014
Results First Received: July 5, 2017
Last Updated: July 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Barbara J. Mason, 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
Alcoholism
Marijuana Abuse
Pathologic Processes
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental 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 21, 2017