Resistance Exercise and Cannabis Use

• ClinicalTrials.gov Identifier: NCT03867786
• Recruitment Status: Not yet recruiting
• First Posted: March 8, 2019
• Last Update Posted: January 20, 2023
• Sponsor: Penn State University
• Information provided by (Responsible Party): Gwendolyn Thomas, Penn State University

Tracking Information

• First Submitted Date: February 11, 2018
• First Posted Date: March 8, 2019
• Last Update Posted Date: January 20, 2023
• Estimated Study Start Date: February 1, 2023
• Estimated Primary Completion Date: August 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 7, 2019)

• 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"
• Cannabis Craving [ Time Frame: Change from baseline ]
  Total Ghrelin as measured by 0.5mL plasma
• Cannibis Consumption [ Time Frame: change from Baseline ]
  endocannabinoid N-arachidonoylethanolamine (AEA)

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Resistance Exercise and Cannabis Use
• Official Title: The Acute Effects of Resistance Exercise on Cannabis Use and Craving
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cannabis Use Disorder

Intervention

• Behavioral: Exercise
  Participants will complete an acute exercise visit.
• Behavioral: Video Control
  Participants will complete a video control visit.

Study Arms

• Experimental: Exercise Condition
  Participants will undergo a 40 minute exercise protocol
  Intervention: Behavioral: Exercise
• Active Comparator: Video Control Condition
  Participants will view a 40 minute nature video
  Intervention: Behavioral: Video Control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: March 7, 2019): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2024
• Estimated Primary Completion Date: August 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. 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.
2. Untrained (no structured exercise program for at least the previous 6 months) as verified by self-report on a physical activity form.
3. 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.
4. No known endocrine disorders (including, but not limited to Hyperthyroidism, Hypothyroidism, Hyperparathyroidism, Cushing's Syndrome, Diabetes mellitus, metabolic syndrome or other inflammatory disorders).
5. No history of blood clotting disorders.
6. Able to read English and complete study assessments
7. Voluntarily provide informed consent and sign the informed consent document.
8. Able to provide negative toxicology screenings for substances, except for cannabis, at intake.

Exclusion Criteria:

1. Meet current criteria for a moderate or severe substance use disorder for any other substance besides cannabis
2. Have any current psychiatric disorders with acute symptoms (i.e., psychosis, suicidal, homicidal, current mania).
3. Younger or older than the specified age range of 18-30.
4. Any endocrine, bone, muscle problems, previous injuries, back problems, or blood clotting disorders.
5. Cardiac and severe respiratory illnesses (i.e. arrhythmias, enlarged heart, COPD) -

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 30 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Gwendolyn Thomas, PhD; 8148633172; gat112@psu.edu

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03867786
• Other Study ID Numbers: 12345
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Gwendolyn Thomas, Penn State University
• Original Responsible Party: gwthomas, Syracuse University, Assistant Professor, Exercise Science
• Current Study Sponsor: Penn State University
• Original Study Sponsor: Syracuse University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Penn State University
• Verification Date: January 2023