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Interactions Between Physical Activity and Cannabis Use in Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Maciej Buchowski, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00838448
First received: January 23, 2009
Last updated: November 23, 2011
Last verified: November 2011
History of Changes
  Purpose

In this study the investigators will explore the relationship between physical activity and cannabis use. The investigators will compare regional brain activation detected by imaging technique(fRMI) before and after exercise in cannabis users and compare results with results from controls. The investigators hypothesize that the regional brain activation in response to visual cues (pictures related to cannabis use and food) will be different in cannabis users than in controls and that exercise will significantly alter brain responses to the cues.


Condition Intervention
Cannabis Dependence
 Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Interactions Between Physical Activity and Cannabis Use in Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Craving for cannabis [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: June 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cannabis users
Cannabis users
 Behavioral: Exercise
Exercise performed on a treadmill for 20-30 minutes
Experimental: Cannabis no-users
Cannabis no-users
 Behavioral: Exercise
Exercise performed on a treadmill for 20-30 minutes

Detailed Description:

It is unknown how the response of cannabis users might compare to those of non-users in response to similar dose of physical activity. We will therefore compare brain activation during craving to cannabis, a natural reward (food) and a neutral scene (nature images). The food cues will allow us to determine if effects of exercise on brain activation and craving generalize to two different reward conditions and the nature scenes provide a neutral, no rewarding control. In addition to the analysis of predetermined regions of interest, whole-brain exploratory analyses will also be conducted to examine for additional brain regions showing associations between various conditions of interest and regional brain activation.

Specific Aims

1. To explore methodological factors involved in finding the relationship between PA and cannabis use.

  1. to examine the effects of cannabis and food cues on brain activation and craving in cannabis users and nonusers
  2. to examine the effects of vigorous exercise on brain activation and craving in response to cannabis and food cues.

Our working hypothesis is that the regional brain activation in response to drug cues will be different in cannabis users than in controls and that exercise will significantly alter brain responses to these cues in both groups. Our secondary hypothesis is that exercise will tend to normalize the abnormal brain activation observed in cannabis users.

Our expectation is that exercise will alter cue-responding in terms of brain activation or craving. It is possible that exercise may be a useful treatment in cannabis dependence. Future studies may examine this specific relationship.

There are no reports available exploring the relationship between physical activity and cannabis use.

Current data suggest that there are convergent findings regarding the chronic and acute effects of cannabis on brain activity

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cases and Controls must:

    • Be able to understand the study and provide written informed consent.
    • Be male or female 18 -35 years of age.
    • Be in generally good health
    • If female of childbearing potential, have a negative serum pregnancy test on study day

Cases must:

  • Meet criteria for cannabis dependence as primary diagnosis as determined by the Substance Abuse module of SCID (Structured Clinical Interview for DSM-IV).
  • Not currently seeking treatment for cannabis dependence.
  • Have a positive urine drug test for cannabis on the study day
  • Avoid alcohol and other recreational drug use (except cannabis and/or nicotine) for 48 h before testing.

Exclusion Criteria:

  • Cases and Controls must not:

    • Be pregnant or lactating
    • Have implanted electrical medical device (e.g. pacemaker, vagal nerve stimulator)
    • Have non-secure metallic foreign bodies
    • Have met criteria for another axis 1 diagnosis in the past 6 months
    • Receive psychotropically active or vasoactive medications (within 6 weeks of screen day)
    • Have chronic medical illness
    • Have epilepsy
    • Have a history of head injury that required hospitalization
    • Have claustrophobia
    • Have orthopedic or other problems precluding them from performing exercise protocol
    • Have body mass index (BMI) less than 19 kg/m2
    • Weighing more than 275 pounds (MRI table limit)

Cases must not:

  • Have current dependence, as determined by the SCID, on any psychoactive substance other than nicotine and/or cannabinoid
  • Have any serious medical or psychiatric illnesses and/or clinically significant symptoms, which in the judgment of the PI or his/her designee would make them unsafe, or would make compliance with the study protocol difficult or put the study staff at undue risk
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838448

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Maciej S Buchowski, Ph.D. Vanderbilt University
  More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Maciej Buchowski, Research Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00838448     History of Changes
Other Study ID Numbers: 081302
Study First Received: January 23, 2009
Last Updated: November 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
exercise
cannabis use
visual cues

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013