Clinical trial NCT00656487: Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults
Official title: Translational Center on the Clinical Neurobiology of Cannabis Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cannabis Dependence
Cannabis Withdrawal
Keywords: Cannabis Dependence
Marijuana Dependence
Cannabis Withdrawal
Rimonabant
cannabinoid receptor type 1 (CB1) inverse agonist
Neuropsychology
functional magnetic resonance imaging (fMRI)
Endocannabinoids
Cortisol
Lead sponsor: The Scripps Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-04-11
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Day 28
measure: Plasma Norepinephrine
timeFrame: Day 28
measure: Plasma Cortisol
timeFrame: Day 28
measure: Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at Day 28
timeFrame: Day 0 and Day 28
measure: Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Total Errors at Day 28
timeFrame: Day 0 and Day 28
measure: 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
timeFrame: Day 0 and Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: The Scripps Research Institute
state: California
Study officials:
affiliation: The Scripps Research Institute
name: Barbara J Mason, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: