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Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults (SCCAN)

Primary Purpose

Cannabis Dependence, Cannabis Withdrawal

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rimonabant
placebo
Sponsored by
The Scripps Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cannabis Dependence focused on measuring Cannabis Dependence, Marijuana Dependence, Cannabis Withdrawal, Rimonabant, cannabinoid receptor type 1 (CB1) inverse agonist, Neuropsychology, functional magnetic resonance imaging (fMRI), Endocannabinoids, Cortisol

Eligibility Criteria

21 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Scripps Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Cannabis-dependent rimonabant

Cannabis-dependent placebo

Non-cannabis using control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 7, 2008
Last Updated
May 23, 2017
Sponsor
The Scripps Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00656487
Brief Title
Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults
Acronym
SCCAN
Official Title
Translational Center on the Clinical Neurobiology of Cannabis Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 30, 2008 (Actual)
Primary Completion Date
December 28, 2010 (Actual)
Study Completion Date
January 6, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Scripps Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabis-dependent rimonabant
Arm Type
Experimental
Arm Description
Cannabis dependent young adults administered rimonabant 90 mg at Day 0 and followed for 28 days post.
Arm Title
Cannabis-dependent placebo
Arm Type
Placebo Comparator
Arm Description
Cannabis dependent young adults administered matched placebo at Day 0 and followed for 28 days post.
Arm Title
Non-cannabis using control
Arm Type
No Intervention
Arm Description
Non-cannabis using demographically similar young adults followed for 28 days.
Intervention Type
Drug
Intervention Name(s)
rimonabant
Other Intervention Name(s)
CB1 receptor antagonist
Intervention Description
double blind, placebo controlled, single 90 mg dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
matched placebo
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Day 28
Title
Plasma Norepinephrine
Description
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.
Time Frame
Day 28
Title
Plasma Cortisol
Description
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.
Time Frame
Day 28
Title
Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at Day 28
Description
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.
Time Frame
Day 0 and Day 28
Title
Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Total Errors at Day 28
Description
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.
Time Frame
Day 0 and Day 28
Title
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
Description
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.
Time Frame
Day 0 and Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J Mason, Ph.D.
Organizational Affiliation
The Scripps Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Scripps Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults

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