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Completed

NCT Number: NCT00656487

Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults

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.

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Key information

Conditions

Cannabis Dependence Cannabis Withdrawal Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

21 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Scripps Research Institute

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rimonabant

Drug

double blind, placebo controlled, single 90 mg dose

Other names: CB1 receptor antagonist

Placebo

Drug

matched placebo

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Scripps Research Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Translational Center on the Clinical Neurobiology of Cannabis Addiction

Acronym: SCCAN

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Apr 11, 2008
Registry last updated
Jun 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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