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Interactions Between Physical Activity and Cannabis Use in Adults

Primary Purpose

Cannabis Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cannabis Dependence focused on measuring exercise, cannabis use, visual cues

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cannabis users

Cannabis no-users

Arm Description

Cannabis users

Cannabis no-users

Outcomes

Primary Outcome Measures

Craving for cannabis

Secondary Outcome Measures

Full Information

First Posted
January 23, 2009
Last Updated
June 11, 2013
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT00838448
Brief Title
Interactions Between Physical Activity and Cannabis Use in Adults
Official Title
Interactions Between Physical Activity and Cannabis Use in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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. to examine the effects of cannabis and food cues on brain activation and craving in cannabis users and nonusers 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence
Keywords
exercise, cannabis use, visual cues

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabis users
Arm Type
Experimental
Arm Description
Cannabis users
Arm Title
Cannabis no-users
Arm Type
Experimental
Arm Description
Cannabis no-users
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Exercise performed on a treadmill for 20-30 minutes
Primary Outcome Measure Information:
Title
Craving for cannabis
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maciej S Buchowski, Ph.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24035535
Citation
Charboneau EJ, Dietrich MS, Park S, Cao A, Watkins TJ, Blackford JU, Benningfield MM, Martin PR, Buchowski MS, Cowan RL. Cannabis cue-induced brain activation correlates with drug craving in limbic and visual salience regions: preliminary results. Psychiatry Res. 2013 Nov 30;214(2):122-31. doi: 10.1016/j.pscychresns.2013.06.005. Epub 2013 Sep 12.
Results Reference
derived
PubMed Identifier
21408154
Citation
Buchowski MS, Meade NN, Charboneau E, Park S, Dietrich MS, Cowan RL, Martin PR. Aerobic exercise training reduces cannabis craving and use in non-treatment seeking cannabis-dependent adults. PLoS One. 2011 Mar 8;6(3):e17465. doi: 10.1371/journal.pone.0017465.
Results Reference
derived

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Interactions Between Physical Activity and Cannabis Use in Adults

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