Cannabis DependenceNCT00838448
Interactions Between Physical Activity and Cannabis Use in Adults
A study testing Exercise in people with Cannabis Dependence, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Dependence
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
Read the 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
- 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
- Conditions
- Cannabis Dependence
- Being tested
- Exercise
- Keywords
- exercise, cannabis use, visual cues
- Medical subject headings
- Marijuana Abuse, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise performed on a treadmill for 20-30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Cannabis users | Experimental | Cannabis users Receives: Behavioral: Exercise |
| Cannabis no-users | Experimental | Cannabis no-users Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving for cannabis
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cannabis DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maciej Buchowski, Vanderbilt University
- Investigators
- Maciej S Buchowski, Ph.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838448
- Sponsor's protocol ID
- 081302
- Status last verified
- Jun 2013
- First submitted
- 23 Jan 2009
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24035535Buchowski 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.
PubMed 21408154
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactions Between Physical Activity and Cannabis Use in Adults
- ClinicalTrials.gov ID
- NCT00838448
- Acronym / sponsor ID
- 081302
- Conditions
- Cannabis Dependence
- Keywords
- exercise, cannabis use, visual cues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis users | Experimental | Behavioral: ExerciseCannabis users |
| Cannabis no-users | Experimental | Behavioral: ExerciseCannabis no-users |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Cases and Controls 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.
Key exclusion criteria (16 listed)
- Cases and Controls 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise performed on a treadmill for 20-30 minutes | Behavioural | Cannabis no-users, Cannabis users |
Primary outcome
Craving for cannabis
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
- Derived from this study: PubMed 24035535Charboneau 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.
- Derived from this study: PubMed 21408154Buchowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maciej S Buchowski, Ph.D. principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cannabis Dependence, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving for cannabis (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00838448, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.