Neurobiology of Cannabis Dependence

Cannabis Dependence Clinical Trial

— SCCAN  

Official title:

Neurobiology of Cannabis Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656487
• Other study ID #: DA024194
• Secondary ID: DA024194
• Status: Completed
• Phase: N/A
• First received: April 7, 2008
• Last updated: July 19, 2012
• Start date: April 2008
• Est. completion date: November 2010

Study information

• Verified date: July 2012
• Source: The Scripps Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cannabis Dependence
• Cannabis Withdrawal
• Marijuana Abuse

Intervention

Drug:
• rimonabant
double blind, placebo controlled, single dose
• placebo
placebo

Locations

Country	Name	City	State
United States	The Scripps Research Institute	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
The Scripps Research Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannabis Withdrawal		2 times per week for 28 days	No
Primary	Neuroendocrine and monoamine assays		2 times over 28 days	No
Primary	Neuropsychological performance		baseline and final study visit	No
Primary	fMRI		baseline and final visit	No
Secondary	Mood		1 time per week for 28 days	No
Secondary	Anxiety		1 time per week for 28 days	No
Secondary	Craving		2 times per week for 28 days	No