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NCT Number: NCT07091292

Exercise Intervention as Treatment for People Using Cannabis (ExIT-C)

In Hong Kong, although the total number of drug abusers is trending down in recent years, the number of cannabis users continues to surge. The misuse of cannabis, if left unattended, predisposes various degrees of dependence and use disorders, which could later on induce psychotic disorders and schizophrenia. Effective strategies combating cannabis dependence and cannabis use disorder (CUD) are therefore warranted.

Exercise presents as a low-cost and low-stigma alternative to traditional pharmacotherapy and psychotherapy in the treatment of substance use disorders, which also promotes physical well-being with virtually no side effects. While exercise has some success in treating use disorders of stimulants, alcohol, and tobacco, evidence of its effects on CUD remains scarce. Hence, the present study will be conducted to assess the effectiveness of a 12-week aerobic exercise training regimen on reducing cannabis dependence and the severity of CUD.

Participants with cannabis dependence will be randomly assigned to either the exercise or the control group. Participants assigned to the exercise group will partake in a 12-week aerobic exercise training program of vigorous-intensity using indoor bikes, whereas those assigned to the control group will perform sham exercise of very light-intensity on indoor bikes. The 12-week study is divided into three (3) 4-week phases:

1. Intensive Intervention - all participants will exercise twice a week under supervision. 2. Active Intervention - all participants will exercise once a week under supervision. 3. Passive Maintenance - no supervised exercise sessions will be provided. All participants will receive exercise reminders via weekly text messages.

Cannabis use-related, cognitive, and physical outcomes will be assessed every 4 weeks, whereas withdrawal symptoms will be assessed and urine quick test administered every week.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Young adults of 18-40 years old
  • Able to read and communicate in English and/or Chinese
  • Able to give informed consent
  • Using cannabis or marijuana as the primary psychoactive substance of abuse
  • Suffering from cannabis addiction, defined by:

i. Cannabis Dependence with an SDS score ≥ 3, or ii. Cannabis Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5), or iii. Cannabis Harmful Use or Dependence according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) or Clinical descriptions and diagnostic requirements for International Classification of Diseases 11th Revision (ICD-11) mental, behavioral, and neurodevelopmental disorders.

Exclusion criteria

  • Age < 18 or > 40 years old
  • Unable to read English or Chinese
  • Unable to give informed consent
  • Absolute and/or relative contraindications to exercise training as indicated by the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and the electronic Physical Activity Readiness Medical Examination (ePARmed-X+)
  • Had been diagnosed with the following disorders, including:

i. Neurodevelopmental Disorders DSM-5: Intellectual Disabilities, Communication Disorders, Specific Learning Disorder, Autism Spectrum Disorder and Motor Disorders ICD-11: Disorders of intellectual development (6A00), Developmental speech or language disorders (6A01), Autism spectrum disorder (6A02), Developmental learning disorder (6A03), Developmental motor coordination disorder (6A04), Stereotyped movement disorder (6A06), Primary tics or tic disorders (8A05.0) ii. Other DSM-5 defined Substance Use Disorder greater than mild in severity (i.e., severity score ≥ 2), except for tobacco or caffeine iii. Neurocognitive Disorders (DSM-5, or ICD-11 6D70-72 & 6D80-86)

Treatment and study plan

Indoor Cycling

Behavioral

Indoor cycling at 60-70% HR reserve for 30 minutes.

Primary outcomes

  1. Clinical Diagnosis of Cannabis Use Disorder (CUD)

    Time frame: At enrollment and 4, 8, and 12 weeks after enrollment

    Structured Clinical Interview for DSM-5 Disorders (SCID-5) is used to ascertain the diagnosis and severity of CUD

  2. Psychological Dependence on Cannabis

    Time frame: At enrollment and 4, 8, and 12 weeks after enrollment

    Severity of Dependence Scale (SDS) is used to assess psychological dependence on cannabis

Secondary outcomes

  1. Urine Toxicology Test

    Time frame: At enrollment and 1, 2, 3, 4, 5, 6, 7, 8, and 12 weeks after enrollment

    Drug of Abuse Urine Test Kits is used to ascertain recent use of cannabis and/or other substances

  2. Cannabis Craving

    Time frame: At enrollment and 4, 8, and 12 weeks after enrollment

    Marijuana Craving Questionnaire - Short Form (MCQ-SF) is used to assess cannabis craving

  3. Cannabis Problems

    Time frame: At enrollment and 4, 8, and 12 weeks after enrollment

    Cannabis Problems Questionnaire (CPQ) is used to assess cannabis-related problems

  4. Cannabis Withdrawal

    Time frame: At enrollment and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 weeks after enrollment

    Cannabis Withdrawal Scale (CWS) is used to assess cannabis withdrawal symptoms

  5. Self-Efficacy in Cannabis Use Reduction

    Time frame: At enrollment and 4, 8, and 12 weeks after enrollment

    Marijuana Reduction Strategies Self-Efficacy Scale (MRSSES) is used to assess self-efficacy in reducing cannabis use

  6. Self-reported Substance Use History

    Time frame: At enrollment and 4, 8, and 12 weeks after enrollment

    The frequency and amount of cannabis and substance use in the past 30 days is recorded

  7. Global Cognitive Function

    Time frame: At enrollment and 4, 8, and 12 weeks after enrollment

    Montreal Cognitive Assessment - HK version (MoCA-HK) is used to assess global cognitive function

  8. Psychomotor Speed

    Time frame: At enrollment and 1, 2, 3, 4, 5, 6, 7, 8, and 12 weeks after enrollment

    Digit Symbol Substitution Test (DSST) is used to assess psychomotor speed

  9. Body weight (in kg)

    Time frame: At enrollment and 4, 8, and 12 weeks after enrollment

  10. Height (in cm)

    Time frame: At enrollment

  11. Waist circumference (in cm)

    Time frame: At enrollment and 4, 8, and 12 weeks after enrollment

  12. Cardiopulmonary Capacity

    Time frame: At enrollment and 4, 8, and 12 weeks after enrollment

    Maximal oxygen uptake (V̇O2max) is measured to assess cardiopulmonary capacity

  13. Resting Energy Expenditure

    Time frame: At enrollment and 4, 8, and 12 weeks after enrollment

  14. Self-reported Physical Activity Participation

    Time frame: At enrollment and 9, 10, 11, and 12 weeks after enrollment

    International Physical Activity Questionnaire - Short Form (IPAQ-SF) is used to record the 7-day physical activity participation

Study contacts

Contact information is provided by the study sponsor or research team.

Albert KK Chung, MBBS(HK)

CONTACT

[email protected]

+852-2255-4486

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Exercise Intervention as Treatment for People Using Cannabis (ExIT-C)-a Randomized Controlled Trial to Investigate the Effectiveness of Aerobic Exercise on Cannabis Dependence and Use Disorder

Acronym: ExIT-C

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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