NCT03867786

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2018

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 8, 2019

Completed
3.9 years until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

February 11, 2018

Last Update Submit

January 19, 2023

Conditions

Keywords

Resistance Exercise Neurobiological Mechanisms

Outcome Measures

Primary Outcomes (3)

  • 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"

    change from baseline

  • Cannabis Craving

    Total Ghrelin as measured by 0.5mL plasma

    Change from baseline

  • Cannibis Consumption

    endocannabinoid N-arachidonoylethanolamine (AEA)

    change from Baseline

Study Arms (2)

Exercise Condition

EXPERIMENTAL

Participants will undergo a 40 minute exercise protocol

Behavioral: Exercise

Video Control Condition

ACTIVE COMPARATOR

Participants will view a 40 minute nature video

Behavioral: Video Control

Interventions

ExerciseBEHAVIORAL

Participants will complete an acute exercise visit.

Exercise Condition
Video ControlBEHAVIORAL

Participants will complete a video control visit.

Video Control Condition

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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) -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Gwendolyn Thomas, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Professor, Kinesiology

Study Record Dates

First Submitted

February 11, 2018

First Posted

March 8, 2019

Study Start

February 1, 2023

Primary Completion

August 31, 2023

Study Completion

December 1, 2024

Last Updated

January 20, 2023

Record last verified: 2023-01