Phase 2
Completed N=20
Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence
Source: ClinicalTrials.gov NCT02210195 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8 — 198.3; 55.9 ng/mg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8 |
198.3; 55.9 | — |
| PRIMARY Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8 |
-21.0; -10.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT02210195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.