None listed
Conditions
Brief summary
The study is a prospective, parallel-group randomized controlled trial comparing an exercise versus control intervention across a range of cannabis detoxification outcome measures during a 7-day inpatient admission, with follow-up at 28 days post-discharge. Specifically, the study will compare severity of cannabis withdrawal and cannabis cravings, detoxification completion rates, and adverse events between the two conditions in an intention-to-treat analysis. Mechanisms by which exercise affects cannabis withdrawal will be assessed through the analysis of markers of endogenous cannabinoids, and plasma and urine THC levels.
Interventions
This study will compare a behavioural intervention (exercise) with a control (stretching) regime during standard inpatient detoxification for cannabis withdrawal.
All participants will present with 1 known CVD risk factor (current smoker or have quit within the past 6 months). It is therefore likely that the majority of participants will be classified as “moderate risk” (2 or more CVD risk factors). As such, participants will be screened and the exercise intensity will be maintained at low – mo
This study will compare a behavioural intervention (exercise) with a control (stretching) regime during standard inpatient detoxification for cannabis withdrawal. All participants will present with 1 known CVD risk factor (current smoker or have quit within the past 6 months). It is therefore likely that the majority of participants will be classified as “moderate risk” (2 or more CVD risk factors). As such, participants will be screened and the exercise intensity will be maintained at low – moderate intensity in accordance with American College of Sports Medicine (ACSM) guidelines. Participants assigned to the exercise condition will complete 7 individual consecutive daily sessions of submaximal aerobic training, specifically 35 minutes of static cycling at 60% VO2 max. This will take place in dedicated rooms in each of the withdrawal facilities, equipped with a Kaiser M3 exercise bicycle, computerised cognitive testing equipment, and standard venepuncture facilities. Exercise or control interventions will occur in supervised sessions (sessions will be supervised by either an Exercise Physiology student or by a Registered Nurse who will be trained by CIC Dr Kieron Rooney, or a Nurse who is trained by a trained nurse) at the same time each day (11-12.30 pm) approximately 3 h after a standardized breakfast.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(a) At least 18 years of age, (b) meets ICD-10 criteria for cannabis dependence, (c) reports significant cannabis withdrawal symptoms in previous periods of abstinence, (d) capacity to tolerate moderate exercise, and (e) willing and capable of providing informed consent to the study procedures.
Exclusion criteria
(a) Alcohol dependence (and associated alcohol withdrawal sequel by clinical assessment); (b) Regular use of other drugs (excluding caffeine, alcohol, and tobacco) or injecting drug use more than once per week on average in previous 28 days; (c) Any Drug and Alcohol treatment in the last 28 days; (d) Significant medical conditions impacting upon exercise capacity, metabolism and excretion of cannabinoids, or assessment of cognition and performance (including severe cardiovascular, neurological, hepatic, renal, respiratory and endocrine disorders; or haematological conditions: (e) Active and severe psychiatric disorders that warrant immediate psychiatric treatment (outside of experimental trial conditions), impact upon capacity for consent, or assessment of outcomes, such as psychosis, suicidality, delirium and severe affective disorders (mild or moderate levels of depression or anxiety not excluded); (f) Use of medications that may impact upon the metabolism and excretion of cannabinoids (e.g. CYP450 enyzme inducers/inhibitors), or may impact upon measurement of withdrawal features (e.g. mood stabilisers, sedatives); and (g) Pregnancy (plasma hCG screen in women of child bearing potential).
Outcome results
None listed