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NCT01611948 · ClinicalTrials.gov registry record · Phase 2
Treatment for Cannabis Withdrawal and Dependence
A Phase 2 study of Cannabis Dependence, sponsored by The Scripps Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT01611948: Completed Phase 2 study of Cannabis Dependence, sponsored by The Scripps Research Institute.
NCT01611948 is a Phase 2 study of Cannabis Dependence that has completed, run by The Scripps Research Institute. The registered enrollment target is 70 participants, below the 125-participant average among 12 other Cannabis Dependence trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01611948, a Phase 2 study of Cannabis Dependence, has completed, sponsored by The Scripps Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measureme
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Aprepitant
- BEHAVIORAL Manual-guided behavioral counseling
Study Locations (1)
California
- The Scripps Research Institute - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2011-05 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
What the finished NCT01611948 record still lists
NCT01611948 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 125-participant average among 12 other Cannabis Dependence trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Cannabis Dependence appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01611948 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01611948 about?
NCT01611948 is a clinical study titled "Treatment for Cannabis Withdrawal and Dependence". 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 im...
What is the current status of trial NCT01611948?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2011-05. Estimated completion is 2015-10.
What conditions does trial NCT01611948 study?
This clinical trial studies the following conditions: Cannabis Dependence.
What interventions are being tested in trial NCT01611948?
The interventions under investigation include: Placebo (DRUG), Aprepitant (DRUG), Manual-guided behavioral counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT01611948?
This trial is sponsored by The Scripps Research Institute, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01611948 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cannabis Dependence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01611948's enrollment target sits among peer trials
70 6th of 12 higher than 6 of 12 other Cannabis Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cannabis Dependence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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