Neurobiology of Cannabis Dependence - Full Text View

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:

MedlinePlus related topics: Marijuana

U.S. FDA Resources

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 (Adult)
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

National Institute on Drug Abuse (NIDA)

Investigators


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

More Information


Responsible Party:	Barbara J. Mason, PI, The Scripps Research Institute
ClinicalTrials.gov Identifier:	NCT00656487 History of Changes
Other Study ID Numbers:	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 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

ClinicalTrials.gov processed this record on September 23, 2016

Neurobiology of Cannabis Dependence (SCCAN)