Neurobiology of Cannabis Dependence (SCCAN)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier:
NCT00656487
First received: April 7, 2008
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

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 Intervention
Cannabis Dependence
Cannabis Withdrawal
Drug: rimonabant
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Neurobiology of Cannabis Dependence

Resource links provided by NLM:


Further study details as provided by The Scripps Research Institute:

Primary Outcome Measures:
  • Cannabis Withdrawal [ Time Frame: 2 times per week for 28 days ] [ Designated as safety issue: No ]
  • Neuroendocrine and monoamine assays [ Time Frame: 2 times over 28 days ] [ Designated as safety issue: No ]
  • Neuropsychological performance [ Time Frame: baseline and final study visit ] [ Designated as safety issue: No ]
  • fMRI [ Time Frame: baseline and final visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mood [ Time Frame: 1 time per week for 28 days ] [ Designated as safety issue: No ]
  • Anxiety [ Time Frame: 1 time per week for 28 days ] [ Designated as safety issue: No ]
  • Craving [ Time Frame: 2 times per week for 28 days ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cannabis dependent/rimonabant
Drug: rimonabant
double blind, placebo controlled, single dose
Other Name: CB1 receptor antagonist
Drug: placebo
placebo
Experimental: 2
Cannabis dependent/placebo
Drug: rimonabant
double blind, placebo controlled, single dose
Other Name: CB1 receptor antagonist
Drug: placebo
placebo
No Intervention: 3
Non-using controls

Detailed Description:

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

Ages Eligible for Study:   21 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Cannabis Dependent Subjects:

Inclusion Criteria:

  • males or females 21-30 years of age
  • meets 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
  • high school diploma recipient
  • English native language

Exclusion Criteria:

  • active suicide ideation
  • meets DSM-IV diagnosis for dependence on other substances other than cannabis
  • use of hallucinogens in the past year
  • significant medical disorders
  • pregnant women
  • meets DSM-IV diagnosis for a major Axis I disorder other than cannabis dependence, including mood or anxiety disorders
  • currently taking psychoactive medication
  • history of neurological disorder
  • left-handed
  • color blindness or non correctable vision or hearing problems
  • claustrophobic
  • non-removable metal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656487

Locations
United States, California
The Scripps Research Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
The Scripps Research Institute
Investigators
Principal Investigator: Barbara J Mason, Ph.D. The Scripps Research Institute
  More Information

No publications provided

Responsible Party: Barbara J. Mason, PI, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00656487     History of Changes
Other Study ID Numbers: DA024194, DA024194
Study First Received: April 7, 2008
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by The Scripps Research Institute:
Cannabis Dependence
Marijuana Dependence
Cannabis Withdrawal
Rimonabant
CB1 receptor antagonist
Neuropsychology
fMRI
Endocannabinoids
Cortisol

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014