NCT00656487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
19 days until next milestone

Study Start

First participant enrolled

April 30, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2010

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2011

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

May 15, 2017

Completed
Last Updated

June 19, 2017

Status Verified

May 1, 2017

Enrollment Period

2.7 years

First QC Date

April 7, 2008

Results QC Date

April 5, 2017

Last Update Submit

May 23, 2017

Conditions

Cannabis DependenceCannabis Withdrawal

Keywords

Cannabis DependenceMarijuana DependenceCannabis WithdrawalRimonabantcannabinoid receptor type 1 (CB1) inverse agonistNeuropsychologyfunctional magnetic resonance imaging (fMRI)EndocannabinoidsCortisol

Outcome Measures

Primary Outcomes (6)

  • 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

    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.

    Day 28

  • Plasma Norepinephrine

    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.

    Day 28

  • Plasma Cortisol

    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.

    Day 28

  • Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at 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.

    Day 0 and Day 28

  • Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Total Errors at 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.

    Day 0 and Day 28

  • 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

    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.

    Day 0 and Day 28

Study Arms (3)

Cannabis-dependent rimonabant

EXPERIMENTAL

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

Drug: rimonabant

Cannabis-dependent placebo

PLACEBO COMPARATOR

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

Drug: placebo

Non-cannabis using control

NO INTERVENTION

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

Interventions

rimonabantDRUG

double blind, placebo controlled, single 90 mg dose

Also known as: CB1 receptor antagonist
Cannabis-dependent rimonabant
placeboDRUG

matched placebo

Cannabis-dependent placebo

Eligibility Criteria

Age21 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Scripps Research Institute

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Rimonabant

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Results Point of Contact

Title
Dr. Barbara Mason
Organization
The Scripps Research Institute
mason@scripps.edu
(858) 784-7324

Study Officials

  • Barbara J Mason, Ph.D.

    The Scripps Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 11, 2008

Study Start

April 30, 2008

Primary Completion

December 28, 2010

Study Completion

January 6, 2011

Last Updated

June 19, 2017

Results First Posted

May 15, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)