Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults (SCCAN)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Cannabis Dependence; Cannabis Withdrawal	Drug: rimonabant; Drug: placebo	Phase 2

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Cannabis-dependent rimonabant; Cannabis dependent young adults administered rimonabant 90 mg at Day 0 and followed for 28 days post.	Drug: rimonabant; double blind, placebo controlled, single 90 mg dose; Other Name: CB1 receptor antagonist
Placebo Comparator: Cannabis-dependent placebo; Cannabis dependent young adults administered matched placebo at Day 0 and followed for 28 days post.	Drug: placebo; matched placebo
No Intervention: Non-cannabis using control; Non-cannabis using demographically similar young adults followed for 28 days.

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Eligibility Criteria

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

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

Contacts and Locations

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Locations

United States, California
The Scripps Research Institute
La Jolla, California, United States, 92037

Sponsors and Collaborators

The Scripps Research Institute

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:	Barbara J Mason, Ph.D.	The Scripps Research Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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