Cannabis Use DisorderNCT03867786
Resistance Exercise and Cannabis Use
A study testing Exercise in people with Cannabis Use Disorder, run by Penn State University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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) -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Acute Effects of Resistance Exercise on Cannabis Use and Craving
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.
Read the 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.
- Conditions
- Cannabis Use Disorder
- Being tested
- Exercise, Video Control
- Keywords
- Resistance Exercise Neurobiological Mechanisms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will complete an acute exercise visit.
Video ControlBehavioural
Participants will complete a video control visit.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Condition | Experimental | Participants will undergo a 40 minute exercise protocol Receives: Behavioral: Exercise |
| Video Control Condition | Active comparator | Participants will view a 40 minute nature video Receives: Behavioral: Video Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: change from baseline
Cannabis Craving
Total Ghrelin as measured by 0.5mL plasma
Measured: Change from baseline
Cannibis Consumption
endocannabinoid N-arachidonoylethanolamine (AEA)
Measured: change from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start1 Feb 2023 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gwendolyn Thomas, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867786
- Sponsor's protocol ID
- 12345
- Status last verified
- Jan 2023
- First submitted
- 11 Feb 2018
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Resistance Exercise on Cannabis Use and Craving
- ClinicalTrials.gov ID
- NCT03867786
- Acronym / sponsor ID
- 12345
- Conditions
- Cannabis Use Disorder
- Keywords
- Resistance Exercise Neurobiological Mechanisms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 8 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Condition | Experimental | Behavioral: ExerciseParticipants will undergo a 40 minute exercise protocol |
| Video Control Condition | Active comparator | Behavioral: Video ControlParticipants will view a 40 minute nature video |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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) -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipants will complete an acute exercise visit. | Behavioural | Exercise Condition |
| Video ControlParticipants will complete a video control visit. | Behavioural | Video Control Condition |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Cannabis Use Disorder
RecruitingPhase 3
Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder
Cannabis Withdrawal
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
Not yet recruitingEarly Phase 1
Research Investigating Drug Effects-2 (RiDE-2)
Cannabis Use, Substance Use Disorder (SUD)
Recruiting
MATAspire: Mental Health Awareness Tailored App for Substance Prevention and Integrated Resilience Education
Alcohol Use, Cannabis Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cannabis Use Disorder, run by Penn State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gwendolyn Thomas, PhD (8148633172, gat112@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannabis Craving (time frame: change from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.