Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cannabis Dependence Cannabis Withdrawal	Drug: rimonabant Drug: placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Translational Center on the Clinical Neurobiology of Cannabis Addiction

Resource links provided by NLM:

MedlinePlus related topics: Marijuana

U.S. FDA Resources

Further study details as provided by Barbara J. Mason, The Scripps Research Institute:

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 [ 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.
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.
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.
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.
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.
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.


Enrollment:	66
Actual Study Start Date:	April 30, 2008
Study Completion Date:	January 6, 2011
Primary Completion Date:	December 28, 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cannabis-dependent rimonabant Cannabis dependent young adults administered rimonabant 90 mg at Day 0 and followed for 28 days post.	Drug: rimonabant double blind, placebo controlled, single 90 mg dose Other Name: CB1 receptor antagonist
Placebo Comparator: Cannabis-dependent placebo Cannabis dependent young adults administered matched placebo at Day 0 and followed for 28 days post.	Drug: placebo matched placebo
No Intervention: Non-cannabis using control Non-cannabis using demographically similar young adults followed for 28 days.

Eligibility


Ages Eligible for Study:	21 Years to 30 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656487

Locations


United States, California
The Scripps Research Institute
La Jolla, California, United States, 92037

Sponsors and Collaborators

The Scripps Research Institute

National Institute on Drug Abuse (NIDA)

Investigators


Principal Investigator:	Barbara J Mason, Ph.D.	The Scripps Research Institute

More Information


Responsible Party:	Barbara J. Mason, PI, The Scripps Research Institute
ClinicalTrials.gov Identifier:	NCT00656487 History of Changes
Other Study ID Numbers:	DA024194 P20DA024194 ( U.S. NIH Grant/Contract )
Study First Received:	April 7, 2008
Results First Received:	April 5, 2017
Last Updated:	May 23, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Barbara J. Mason, The Scripps Research Institute:


Cannabis Dependence Marijuana Dependence Cannabis Withdrawal Rimonabant cannabinoid receptor type 1 (CB1) inverse agonist	Neuropsychology functional magnetic resonance imaging (fMRI) Endocannabinoids Cortisol

Additional relevant MeSH terms:


Marijuana Abuse Cannabinoid Receptor Antagonists Cannabinoid Receptor Modulators Substance-Related Disorders Chemically-Induced Disorders Mental Disorders	Rimonabant Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 25, 2017

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