Treatment for Cannabis Withdrawal and Dependence
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pharmacological Treatment of Cannabis Withdrawal and Dependence|
- Change in Cannabis Use from Baseline to 12 weeks [ Time Frame: Once per week for 12 weeks ] [ Designated as safety issue: No ]Urinary THC
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Active Drug
125mg/day for 8 weeks
Other Name: Emend
Placebo Comparator: Placebo pill
125mg/d placebo pill for 8 weeks
This study will be a Phase II, single-site, 8-week, randomized, double-blind, placebo-controlled, parallel group comparison of aprepitant (125 mg/d) or placebo. Subjects will be 100 outpatients seeking treatment for current cannabis dependence with no clinically significant medical or psychiatric disorders (including substance use disorders or a positive drug screen for substances other than cannabis or nicotine). All subjects will receive weekly manual-guided abstinence-oriented counseling to facilitate showing a drug effect above and beyond available therapies (Weeks 0-8). Research assessments of marijuana use and withdrawal and drug safety and tolerability will occur weekly through the treatment phase of the 8-week study. Post treatment follow-up assessments will occur at Weeks 9 and 12. Neuropsychological testing will occur at Weeks 0 and 4 and 8.
Specific Aim 1: To evaluate the relative efficacy of aprepitant 125 mg/d vs. placebo for reducing cannabis withdrawal symptoms in cannabis dependent outpatients, including anxiety, mood, craving and sleep symptoms.
Specific Aim 2: To evaluate the relative efficacy of aprepitant 125 mg/d vs. placebo for reducing marijuana use in cannabis dependent outpatients.
Specific Aim 3: To evaluate the relative efficacy of aprepitant 125 mg/d vs. placebo for reducing cannabis related impairments in executive functioning in cannabis dependent outpatients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611948
|Contact: Nicholas J. Chesher, Ph.D.||firstname.lastname@example.org|
|United States, California|
|The Scripps Research Institute||Recruiting|
|La Jolla, California, United States, 92037|
|Contact: Nick J. Chesher, M.A. 858-784-7465 email@example.com|
|Principal Investigator: Barbara J Mason, Ph.D.|
|Principal Investigator:||Barbara J Mason, Ph.D.||The Scripps Research Institute|