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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
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder focused on measuring Resistance Exercise Neurobiological Mechanisms

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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) -

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

    First Posted
    February 11, 2018
    Last Updated
    January 19, 2023
    Sponsor
    Penn State University
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    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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