Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | July 2014 |
| End Date: | January 2017 |
| Contact: | Nicholas J Chesher, Ph.D. |
| Email: | nchesher@scripps.edu |
| Phone: | 858-784-7465 |
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.
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.
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.
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.
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
We found this trial at
1
site
La Jolla, California 92037
Principal Investigator: Barbara J. Mason, Ph.D.
Phone: 858-784-7465
Click here to add this to my saved trials
