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

The University of Hong Kong60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Clinical Diagnosis of Cannabis Use Disorder (CUD)

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

Psychological Dependence on Cannabis

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

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

Secondary Outcomes

Urine Toxicology Test

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

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

Cannabis Craving

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

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

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

Cannabis Withdrawal

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

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

Self-Efficacy in Cannabis Use Reduction

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

Self-reported Substance Use History

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

Global Cognitive Function

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

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

Psychomotor Speed

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

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

Body weight (in kg)

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

Height (in cm)

Time frame: At enrollment

Waist circumference (in cm)

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

Cardiopulmonary Capacity

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

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

Resting Energy Expenditure

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

Self-reported Physical Activity Participation

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts