- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03867786
Resistance Exercise and Cannabis Use
The Acute Effects of Resistance Exercise on Cannabis Use and Craving
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cannabis is the most widely used illicit drug and rates of hazardous use, and cannabis use disorders (CUDs), have continued to rise in recent years. The highest rates of use and CUDs are seen in young adults (20 - 24 years old) with more than 50% of young adults reporting lifetime use of cannabis, 35% report use in the past year, and 20% report use in the past month. Increased exposure produces higher risk for detrimental psychological and behavioral effects of cannabis use. Given this increased prevalence of cannabis use and associated risks, identifying effective behavioral strategies that reduce cannabis craving, negative psychological effects, and alter neurobiological mechanisms underlying problematic cannabis use are an avenue of needed research. Exercise, particularly resistance exercise, is a behavioral intervention with considerable potential as an adjunctive treatment for CUD.
The aims of this proposal seek to address these issues by implementing acute resistance exercise protocol in men and women who have cannabis use disorder. This proposal will: 1 examine the effect of an acute resistance exercise protocol on affect, stress, and compulsive urge to use in non-treatment seeking young adults with CUD 2.examine whether an acute resistance exercise session in individuals with CUD is associated with induced alterations in the appetitive/ reward hormone ghrelin These findings will inform the further development for exercise interventions for cannabis use disorder that can be used with the aim of supporting individuals with CUD reduce use and decrease the negative effects of withdrawal.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gwendolyn Thomas, PhD
- Phone Number: 8148633172
- Email: gat112@psu.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy individuals between the ages of 18-30 years who currently meet for a moderate or severe cannabis use disorder according to DSM-5 criteria.
- Untrained (no structured exercise program for at least the previous 6 months) as verified by self-report on a physical activity form.
- No previous bone or muscle problems or previous injuries that would prevent free movement about the shoulder, hip, knee or ankle, or increase the risk of discomfort or injury during exercise. No ongoing back problems.
- No known endocrine disorders (including, but not limited to Hyperthyroidism, Hypothyroidism, Hyperparathyroidism, Cushing's Syndrome, Diabetes mellitus, metabolic syndrome or other inflammatory disorders).
- No history of blood clotting disorders.
- Able to read English and complete study assessments
- Voluntarily provide informed consent and sign the informed consent document.
- Able to provide negative toxicology screenings for substances, except for cannabis, at intake.
Exclusion Criteria:
- Meet current criteria for a moderate or severe substance use disorder for any other substance besides cannabis
- Have any current psychiatric disorders with acute symptoms (i.e., psychosis, suicidal, homicidal, current mania).
- Younger or older than the specified age range of 18-30.
- Any endocrine, bone, muscle problems, previous injuries, back problems, or blood clotting disorders.
- Cardiac and severe respiratory illnesses (i.e. arrhythmias, enlarged heart, COPD) -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise Condition
Participants will undergo a 40 minute exercise protocol
|
Participants will complete an acute exercise visit.
|
|
Active Comparator: Video Control Condition
Participants will view a 40 minute nature video
|
Participants will complete a video control visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cannabis Craving
Time Frame: change from baseline
|
Craving Marijuana Craving Questionnaire (MCQ) The 45-item MCQ is a multi-dimensional questionnaire that assesses marijuana craving.
It is based on the the Cocaine Craving Questionnaire and uses items that touch on four specific constructs characterizing craving for marijuana: (1) compulsivity, an inability to control marijuana use; (2) emotionality, use of marijuana in anticipation of relief from withdrawal or negative mood; (3) expectancy, anticipation of positive outcomes from smoking marijuana; and (4) purposefulness, intention and planning to use marijuana for positive outcomes.
Each item is rated on a seven-point Likert-type scale ranging from "strongly agree to strongly disagree"
|
change from baseline
|
|
Cannabis Craving
Time Frame: Change from baseline
|
Total Ghrelin as measured by 0.5mL plasma
|
Change from baseline
|
|
Cannibis Consumption
Time Frame: change from Baseline
|
endocannabinoid N-arachidonoylethanolamine (AEA)
|
change from Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12345 (Danish Center for Healthcare Improvements)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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