CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Aprepitant +2 moredrug
Likely dose
Aprepitant 125mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01611948
NCT01611948Phase 2Completed

Pharmacological Treatment of Cannabis Withdrawal and Dependence

The Scripps Research Institute·interventional·Posted Jun 5, 2012·Updated May 1, 2017

In Brief

A Phase 2 clinical trial evaluating Aprepitant, Placebo, and 1 other intervention for Cannabis Dependence. Completed, enrolled 70 participants across 1 site.

Detailed Summary

Cannabis is the most widely used illicit drug in the United States, and worldwide, with 1 in 10 users estimated to meet diagnostic criteria for cannabis dependence. Avoidance of withdrawal symptoms (e.g., disturbances in mood, sleep, and craving) is a common relapse precipitant. Cannabis use also impairs executive cognitive functions thereby increasing vulnerability to relapse and reducing the ability to benefit from behavioral therapy. There are no pharmacological treatments for cannabis dependence, despite the large number of afflicted individuals and the limitations of behavioral therapies which do not remediate withdrawal and are associated with high rates of treatment failure. The primary aim of this clinical trial is to evaluate the efficacy and safety of a novel neurokinin1 (NK1) receptor antagonist, aprepitant (Emend), (125mg/day), in outpatients with current cannabis dependence. The main hypothesis to be tested is to evaluate the relative efficacy of aprepitant 125 mg/d vs. placebo for reducing cannabis withdrawal symptoms in cannabis dependent outpatients, specifically anxiety, mood, craving and sleep.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 5, 2012
Enrollment StartMay 1, 2011
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 14.1 years ago

Interventions

Aprepitantdrug

125mg/day for 8 weeks

Placebodrug

125mg/d placebo pill for 8 weeks

Manual-guided behavioral counselingbehavioral

Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.