Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
2 other identifiers
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2014
CompletedFirst Posted
Study publicly available on registry
August 6, 2014
CompletedStudy Start
First participant enrolled
September 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2016
CompletedResults Posted
Study results publicly available
August 2, 2017
CompletedAugust 2, 2017
July 1, 2017
2.3 years
July 31, 2014
July 5, 2017
July 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at 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
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
Study Arms (2)
Experimental: aprepitant 125 mg/day
ACTIVE COMPARATOR125 mg aprepitant daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
Placebo 125mg/d
PLACEBO COMPARATORMatched placebo pill given daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
Interventions
Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Scripps Research Institute
La Jolla, California, 92037, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Barbara Mason
- Organization
- The Scripps Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara J. Mason, Ph.D.
The Scripps Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 31, 2014
First Posted
August 6, 2014
Study Start
September 4, 2014
Primary Completion
December 19, 2016
Study Completion
December 19, 2016
Last Updated
August 2, 2017
Results First Posted
August 2, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share