Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Resistance Exercise and Cannabis Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03867786
Recruitment Status : Not yet recruiting
First Posted : March 8, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
gwthomas, Syracuse University

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.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Behavioral: Exercise Behavioral: Video Control Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Acute Effects of Resistance Exercise on Cannabis Use and Craving
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Condition
Participants will undergo a 40 minute exercise protocol
Behavioral: Exercise
Participants will complete an acute exercise visit.

Active Comparator: Video Control Condition
Participants will view a 40 minute nature video
Behavioral: Video Control
Participants will complete a video control visit.




Primary Outcome Measures :
  1. 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"

  2. Cannabis Craving [ Time Frame: Change from baseline ]
    Total Ghrelin as measured by 0.5mL plasma

  3. Cannibis Consumption [ Time Frame: change from Baseline ]
    endocannabinoid N-arachidonoylethanolamine (AEA)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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) -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867786


Contacts
Layout table for location contacts
Contact: Gwendolyn Thomas, PhD 315-443-1411 gwthomas@syr.edu

Sponsors and Collaborators
Syracuse University

Layout table for additonal information
Responsible Party: gwthomas, Assistant Professor, Exercise Science, Syracuse University
ClinicalTrials.gov Identifier: NCT03867786     History of Changes
Other Study ID Numbers: 12345
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by gwthomas, Syracuse University:
Resistance Exercise Neurobiological Mechanisms
Additional relevant MeSH terms:
Layout table for MeSH terms
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders