Clinical trial NCT02210195: Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
Official title: Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cannabis Dependence
Alcohol Dependence
Cannabis Use Disorder
Alcohol Use Disorder
Keywords: Cannabis Treatment
Alcohol Treatment
Alcohol-Related Disorders
Cannabis-Related Disorders
Substance-Related Disorders
Emend
NK1 receptor antagonist
Alcohol
Cannabis
aprepitant
Lead sponsor: The Scripps Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8
timeFrame: Week 0 and Week 8
measure: Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8
timeFrame: Week 0 and Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: The Scripps Research Institute
state: California
Study officials:
affiliation: The Scripps Research Institute
name: Barbara J. Mason, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: