Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults

NCT ID: NCT00656487

Last Updated: 2017-06-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cannabis Dependence Cannabis Withdrawal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cannabis-dependent rimonabant

Cannabis dependent young adults administered rimonabant 90 mg at Day 0 and followed for 28 days post.

Group Type EXPERIMENTAL

rimonabant

Intervention Type DRUG

double blind, placebo controlled, single 90 mg dose

Cannabis-dependent placebo

Cannabis dependent young adults administered matched placebo at Day 0 and followed for 28 days post.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

matched placebo

Non-cannabis using control

Non-cannabis using demographically similar young adults followed for 28 days.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rimonabant

double blind, placebo controlled, single 90 mg dose

Intervention Type DRUG

placebo

matched placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CB1 receptor antagonist

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

The Scripps Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Barbara J. Mason

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Barbara J Mason, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Scripps Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Scripps Research Institute

La Jolla, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P20DA024194

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DA024194

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Rimonabant to Reduce Alcohol Consumption
NCT00075205 COMPLETED PHASE2
Cannabidiol in Youth Alcohol Use Disorder
NCT05317546 COMPLETED PHASE2
Cannabidiol and Cannabis Concentrate Users
NCT06575751 RECRUITING PHASE2
Cannabinoids and Cerebellar-Motor Functioning
NCT01853020 COMPLETED EARLY_PHASE1