Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults (SCCAN)
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ClinicalTrials.gov Identifier: NCT00656487 |
Recruitment Status
:
Completed
First Posted
: April 11, 2008
Results First Posted
: May 15, 2017
Last Update Posted
: June 19, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cannabis Dependence Cannabis Withdrawal | Drug: rimonabant Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Diagnostic |
Official Title: | Translational Center on the Clinical Neurobiology of Cannabis Addiction |
Actual Study Start Date : | April 30, 2008 |
Actual Primary Completion Date : | December 28, 2010 |
Actual Study Completion Date : | January 6, 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Cannabis-dependent rimonabant
Cannabis dependent young adults administered rimonabant 90 mg at Day 0 and followed for 28 days post.
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Drug: rimonabant
double blind, placebo controlled, single 90 mg dose
Other Name: CB1 receptor antagonist
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Placebo Comparator: Cannabis-dependent placebo
Cannabis dependent young adults administered matched placebo at Day 0 and followed for 28 days post.
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Drug: placebo
matched placebo
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No Intervention: Non-cannabis using control
Non-cannabis using demographically similar young adults followed for 28 days.
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- 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 [ Time Frame: Day 28 ]The MWC is a 28-item instrument that is used to assess the severity of frequently reported cannabis withdrawal symptoms. Each item on the measure is recorded as a severity rating between 0-3 where a zero indicates not present and a three indicates severe. The severity rating of each item was summed to obtain a single marijuana withdrawal severity score ranging between 0- 84. A lower score indicates less severe withdrawal.
- Plasma Norepinephrine [ Time Frame: Day 28 ]Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period.
- Plasma Cortisol [ Time Frame: Day 28 ]Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period.
- Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at Day 28 [ Time Frame: Day 0 and Day 28 ]The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Strategy Score is an estimate of use of the most efficient strategy to complete the task. Scores range from 8-56; higher scores equate to poor use of the most efficient strategy. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement.
- Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Total Errors at Day 28 [ Time Frame: Day 0 and Day 28 ]The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Total Errors are a measure of performance and are unbounded. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement.
- 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 [ Time Frame: Day 0 and Day 28 ]The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Mean Time To First Response is a measure of latency and is unbounded. Change = (Day 28 Time - Day 0 Time). A more negative result indicates greater improvement.

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Ages Eligible for Study: | 21 Years to 30 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656487
United States, California | |
The Scripps Research Institute | |
La Jolla, California, United States, 92037 |
Principal Investigator: | Barbara J Mason, Ph.D. | The Scripps Research Institute |
Responsible Party: | Barbara J. Mason, PI, The Scripps Research Institute |
ClinicalTrials.gov Identifier: | NCT00656487 History of Changes |
Other Study ID Numbers: |
DA024194 P20DA024194 ( U.S. NIH Grant/Contract ) |
First Posted: | April 11, 2008 Key Record Dates |
Results First Posted: | May 15, 2017 |
Last Update Posted: | June 19, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Barbara J. Mason, The Scripps Research Institute:
Cannabis Dependence Marijuana Dependence Cannabis Withdrawal Rimonabant cannabinoid receptor type 1 (CB1) inverse agonist |
Neuropsychology functional magnetic resonance imaging (fMRI) Endocannabinoids Cortisol |
Additional relevant MeSH terms:
Marijuana Abuse Cannabinoid Receptor Antagonists Cannabinoid Receptor Modulators Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |
Rimonabant Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |