An interventional study of High Intensity Interval Training and Strength and Resistance Training in Cannabis Use Disorder, Moderate and Cannabis Use Disorder, Severe, sponsored by Monash University. Completed at 1 site in Australia. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Monash University · Not applicable, Interventional, and Treatment
Heavy cannabis use is associated with substantive learning and memory impairments and elevated risk of psychopathology. It has been repeatedly demonstrated that the hippocampus, centrally implicated in these processes, is particularly vulnerable to the deleterious effects of prolonged exposure to cannabis. This deterioration of hippocampal structure, function, and biochemistry can be reversed, but this requires two or more years of abstinence from cannabis. However, most heavy cannabis users find it extremely difficult to maintain abstinence over extended periods and current treatments for cannabis use disorders are inadequate. There is a pressing clinical need for an intervention that rapidly accelerates hippocampal recovery, ameliorates the associated cognitive impairments and mental health symptoms, and leads to improved treatment outcomes. One promising candidate is physical exercise. In addition to the well-known physical health benefits, regular exercise also has a potent positive effect on brain health. The current study will investitive the capacity of two different neuroscientifically-informed 12-week exercise programs can restore brain health for heavy long term cannabis users.
Heavy cannabis use is associated with substantive learning and memory impairments and elevated risk of psychopathology. It has been repeatedly demonstrated that the hippocampus, centrally implicated in these processes, is particularly vulnerable to the deleterious effects of prolonged exposure to cannabis. This deterioration of hippocampal structure, function, and biochemistry can be reversed, but this requires two or more years of abstinence from cannabis. However, most heavy cannabis users find it extremely difficult to maintain abstinence over extended periods and current treatments for cannabis use disorders are inadequate. There is a pressing clinical need for an intervention that rapidly accelerates hippocampal recovery, ameliorates the associated cognitive impairments and mental health symptoms, and leads to improved treatment outcomes. One promising candidate is physical exercise. In addition to the well-known physical health benefits, regular exercise also has a potent positive effect on brain health and can increase the size of the hippocampus. It's not yet known how much or what kind of exercise produces the best results. This study has been designed to compare the effects of two different exercise programs.
The research team are investigating whether the programs have a positive impact on brain health and, if they do, whether one is more effective than the other. The research team will also measure whether engaging in either program leads to a reduction in cannabis consumption, and improvements in thinking skills, mental health, and general wellbeing.
517 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.
This study's enrollment of 65 is close to the median of 60 across 421 interventional studies indexed under Marijuana Abuse.
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Exclusion Criteria:
12-week, 36 session, cardiorespiratory-focussed physical exercise program delivered by an accredited exercise physiologist
Behavioral: High Intensity Interval Training
12- week, 36 session, strength-focussed physical exercise program delivered by an accredited exercise physiologist
Behavioral: Strength and Resistance Training
Exercise sessions will commence with an initial 3-week accustomization period whereby training load will increase incrementally from 2 x 45min sessions with effort peaking at 60% VO2 max (week 1) increasing to 3 x 45minute with effort peaking at 80% VO2max (week 3). Participants will transition to the full HIIT protocol for the remaining weeks. The HIIT component will comprise a work-rest ratio of ≥1:1minutes, with alternating exertion epochs at \>80% VO2max and \<60% VO2max. As VO2max is likely to increase as fitness improves toward the end of the 3-month program, adjustments to HIIT will be made by the exercise physiologist based on real-time heart rate monitoring, ensuring greater accuracy in participants achieving their heart rate targets.
Exercise sessions will comprise a combination of strength, coordination and mobility exercises. The strength component will consist of 2-3 sets of resistance exercises at ≤70% of a predicted 1 repetition maximum, targeting all body segments. Heart rate tracking will occur to ensure participants do not exceed 70% v02 (or exceed Lactate Threshold).
Change in hippocampal integrity
Composite score derived from three hippocampal health indices: volume (structural MRI), connectivity (DTI), neuronal health (MRS NAA) calculated as described in Yucel et al (2016), doi:10.1038/tp.2015.201.
Time frame: Baseline (0 months), post (3 months)
Change in cannabis use
Time line follow back
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in cannabis dependence
Severity of Dependence Scale (SDS; range = 0-15 higher scores indicate higher dependence
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in cannabis craving
Penn Craving Scale (PCS; range = 0 - 30 higher scores indicate greater craving)
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in depression symptoms
Quick Inventory of Depressive Symptomology (QUIDS; range = 0 - 27 higher scores indicate greater depression symptom severity)
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in anxiety symptoms
StateTrait Anxiety Inventory (STAI; range = 20 to 80, higher scores indicate greater anxiety)
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in resilience
Connor David Resilience Scale (CDRS; range = 0-100 higher scores indicate higher resilience)
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in coping skills
Perceived Stress Scale (10 item; range = 0 - 40 higher scores indicate greater stress)
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in sleep quality
Pittsburgh Sleep Quality Index (PSQI; range = 0 to 21 higher scores indicate worse sleep quality)
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in mental wellbeing
Warwick Edinburgh Mental Wellbeing Scale (WEMWBS; range = 14-70 higher scores indicate increased mental well being)
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in quality of life
Quality of Life and Satisfaction Questionnaire - Short Form (QOL-SF; range = 70 higher scores indicate greater life satisfaction and enjoyment)
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in memory
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in associative memory
Paired Associates Learning Task (PAL)
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in visual memory
Figural Memory Tasks
Time frame: Baseline (0 months), post (3 months)
Change in cardiorespiratory fitness
VO2 max
Time frame: Baseline (0 months), post (3 months)
Plan to share: No
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Monash University