Resistance Exercise and Cannabis Use
Primary Purpose
Cannabis Use Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Video Control
Sponsored by
About this trial
This is an interventional treatment trial for Cannabis Use Disorder focused on measuring Resistance Exercise Neurobiological Mechanisms
Eligibility Criteria
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) -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise Condition
Video Control Condition
Arm Description
Participants will undergo a 40 minute exercise protocol
Participants will view a 40 minute nature video
Outcomes
Primary Outcome Measures
Cannabis Craving
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"
Cannabis Craving
Total Ghrelin as measured by 0.5mL plasma
Cannibis Consumption
endocannabinoid N-arachidonoylethanolamine (AEA)
Secondary Outcome Measures
Full Information
NCT ID
NCT03867786
First Posted
February 11, 2018
Last Updated
January 19, 2023
Sponsor
Penn State University
1. Study Identification
Unique Protocol Identification Number
NCT03867786
Brief Title
Resistance Exercise and Cannabis Use
Official Title
The Acute Effects of Resistance Exercise on Cannabis Use and Craving
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder
Keywords
Resistance Exercise Neurobiological Mechanisms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Condition
Arm Type
Experimental
Arm Description
Participants will undergo a 40 minute exercise protocol
Arm Title
Video Control Condition
Arm Type
Active Comparator
Arm Description
Participants will view a 40 minute nature video
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Participants will complete an acute exercise visit.
Intervention Type
Behavioral
Intervention Name(s)
Video Control
Intervention Description
Participants will complete a video control visit.
Primary Outcome Measure Information:
Title
Cannabis Craving
Description
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"
Time Frame
change from baseline
Title
Cannabis Craving
Description
Total Ghrelin as measured by 0.5mL plasma
Time Frame
Change from baseline
Title
Cannibis Consumption
Description
endocannabinoid N-arachidonoylethanolamine (AEA)
Time Frame
change from Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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) -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gwendolyn Thomas, PhD
Phone
8148633172
Email
gat112@psu.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Resistance Exercise and Cannabis Use
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