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NCT01153490 · ClinicalTrials.gov registry record · Phase 4
Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine
A Phase 4 study of Cannabis Dependence, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 124
- Enrollment target
- 2
- Study locations
NCT01153490: Completed Phase 4 study of Cannabis Dependence, sponsored by Northwell Health.
NCT01153490 is a Phase 4 study of Cannabis Dependence that has completed, run by Northwell Health. The registered enrollment target is 124 participants, roughly in line with the 120-participant average among 12 other Cannabis Dependence trials with a reported enrollment target. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01153490, a Phase 4 study of Cannabis Dependence, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 124 participants
- Enrollment target
- 2
- Study locations
Study Summary
Cannabis is the most used illicit substance in the United States. Previous studies suggest that atypical antipsychotics decrease the frequency and the amount of substance use in subjects with and without psychotic illness. So far, there are no controlled studies assessing the effectiveness of atypical antipsychotics for decreasing cannabis and other substance use in individuals with cannabis use disorders. The investigators postulate that the atypical antipsychotic quetiapine ER is an effective agent for improving substance use outcomes in subjects with cannabis use disorders. In this pilot study, the investigators will test this hypothesis in heavy cannabis users (i.e., individuals who are cannabis dependent and smoke three times or more per week). Because 50% of these heavy cannabis users report histories of psychotic experiences (i.e., attenuated positive symptoms) while smoking and are at risk for recurring psychotic symptoms, the investigators will focus this pilot clinical trial on this subgroup of cannabis users in order to increase the risk/benefit ratio of this study and target a population that may also benefit from the antipsychotic effect of quetiapine ER. Considering the lack of controlled studies assessing the efficacy of atypical antipsychotics in heavy cannabis users, assessing the effectiveness of an atypical antipsychotic medication on substance use and clinical outcomes in this population is critical for improving the prognosis of these individuals. Thus, the aims of this randomized, double-blind, placebo-controlled study are to assess the efficacy of an atypical antipsychotic (quetiapine ER) in 120 subjects with cannabis dependence, a recent history (within a year) of attenuated psychotic symptoms, and using cannabis 3 times or more per week for: (1) decreasing the use of cannabis and other substances; and (2) preventing the recurrence of psychotic experiences. The investigators will also assess the effects of quetiapine ER on craving and mood,
Primary Outcome
frequency and amount of cannabis and other substance use will be recorded with the Timeline Follow-Back Method.
Conditions Studied
Interventions
- BEHAVIORAL Behavioral Intervention
Study Locations (2)
New York
- The Zucker Hillside Hospital - Glen Oaks
- General Clinical Research Center - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2010-10-22 |
| Est. Completion | 2012-08-06 |
| Phase | Phase 4 |
What the finished NCT01153490 record still lists
NCT01153490 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 120-participant average among 12 other Cannabis Dependence trials with a reported enrollment target.
The record links to 1 condition, with Cannabis Dependence appearing as the primary indexed condition, and to 1 intervention - of which Behavioral Intervention is the first listed.
NCT01153490 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01153490 about?
NCT01153490 is a clinical study titled "Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine". Cannabis is the most used illicit substance in the United States. Previous studies suggest that atypical antipsychotics decrease the frequency and the amount of substance use in subjects with and without psychotic illness. So far, there are no controlled studies assessing the effectiveness of atypic...
What is the current status of trial NCT01153490?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 124 participants. The study started on 2010-10-22. Estimated completion is 2012-08-06.
What conditions does trial NCT01153490 study?
This clinical trial studies the following conditions: Cannabis Dependence.
What interventions are being tested in trial NCT01153490?
The interventions under investigation include: Behavioral Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01153490?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01153490 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01153490's enrollment target sits among peer trials
124 2nd of 12 the highest 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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