Status:
COMPLETED
Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
Lead Sponsor:
The Scripps Research Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cannabis Dependence
Alcohol Dependence
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02210195
Start Date
September 4 2014
End Date
December 19 2016
Last Update
August 2 2017
Active Locations (1)
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1
The Scripps Research Institute
La Jolla, California, United States, 92037