Queen Mary Hospital
Hong Kong
Location status: Recruiting
NCT Number: NCT07091292
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.
Interested in participating?
Request Info18 year–40 year
All sexes
Interventional
Not applicable
Hong Kong
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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)
Indoor cycling at 60-70% HR reserve for 30 minutes.
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
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
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
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
Time frame: At enrollment and 4, 8, and 12 weeks after enrollment
Cannabis Problems Questionnaire (CPQ) is used to assess cannabis-related problems
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
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
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
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
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
Time frame: At enrollment and 4, 8, and 12 weeks after enrollment
Time frame: At enrollment
Time frame: At enrollment and 4, 8, and 12 weeks after enrollment
Time frame: At enrollment and 4, 8, and 12 weeks after enrollment
Maximal oxygen uptake (V̇O2max) is measured to assess cardiopulmonary capacity
Time frame: At enrollment and 4, 8, and 12 weeks after enrollment
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
Contact information is provided by the study sponsor or research team.
The University of Hong Kong
Other
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
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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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