Phase 2
N=66
Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults
Cannabis Dependence · Cannabis Withdrawal
Bottom Line
View on ClinicalTrials.gov: NCT00656487 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at 28 Days Following Single Dose Administration of Rimonabant or Placebo, or Commencement of Monitoring, During the Double-Blind Period — 6.62; 6.68; 1.05 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rimonabant (Drug); placebo (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- The Scripps Research Institute
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at 28 Days Following Single Dose Administration of Rimonabant or Placebo, or Commencement of Monitoring, During the Double-Blind Period |
6.62; 6.68; 1.05 | — |
| PRIMARY Plasma Norepinephrine |
2.12; 2.04; 1.75 | — |
| PRIMARY Plasma Cortisol |
27.36; 19.29; 22.72 | — |
| PRIMARY Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at Day 28 |
-2.67; -1.37; -1.50 | — |
| PRIMARY Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Total Errors at Day 28 |
-10.62; -1.95; -2.85 | — |
| PRIMARY Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Mean Time To First Response at Day 28 |
-139.80; 420.24; 22.01 | — |
Summary
The purpose of this study is to find out more about cognitive functioning in people who are cannabis dependent, relative to people who do not use cannabis, and how their brains process information after one month of not using cannabis. An additional goal is to characterize the severity of cannabis dependence using precipitated and naturalistic withdrawal with a double blind, placebo controlled, single administration of rimonabant. Research assessments occur bi-weekly throughout this 28 day study.
Eligibility Criteria
Cannabis Dependent Subjects:
Inclusion Criteria
- males or females 21-30 years of age
- meets Diagnostic and Statistical Manual (DSM-IV) diagnosis of Cannabis Dependence
- willing to be abstinent for 28 days during study
- smokes < 10 cigarettes per day
- drinks < 1 (female) or < 2 (male) per day
Exclusion Criteria
- active suicide ideation
- meets DSM-IV diagnosis for dependence on other substances other than cannabis
- significant medical disorders
- pregnant women
- meets DSM-IV diagnosis for a major Axis I disorder other than cannabis dependence
- currently taking psychoactive medication
Data sourced from ClinicalTrials.gov (NCT00656487). 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.