MedPath

Brain Exercise and Addiction Trial

Not Applicable
Completed
Conditions
Cannabis Use Disorder, Severe
Cannabis Use Disorder, Moderate
Interventions
Behavioral: Strength and Resistance Training
Behavioral: High Intensity Interval Training
Registration Number
NCT04902092
Lead Sponsor
Monash University
Brief Summary

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.

Detailed Description

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.

1. 12 weeks of regular HIIT exercise

2. 12 weeks of regular strength training

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
65
Inclusion Criteria
  1. Aged 20-55 years
  2. Voluntary and able to provide informed consent
  3. Fluent in English
  4. Current moderate - severe cannabis use disorder
  5. Major history of cannabis use (i.e. ≥3 days per week on average for ≥4 of the past 6 years)
  6. Capacity to tolerate physical exercise according to 'Fitness to Exercise'
Exclusion Criteria
  1. Have a history of cardiovascular disease, high blood pressure, musculoskeletal injury or other condition that would preclude safe engagement in VO2 max fitness testing and/or regular physical exercise
  2. Severe claustrophobia, non-MR compatible metallic implant, or other contraindication to MRI scanning
  3. Lifetime history of significant neurological illness, or moderate - severe brain injury,
  4. Current major unstable medical illness or chronic pain condition
  5. Lifetime history of schizophrenia, schizoaffective disorder, OCD, PTSD, bipolar disorder
  6. Current significant depression or anxiety that precludes ability to reliably engage in the exercise program
  7. Current moderate - severe substance use disorder for substances other than cannabis (excluding nicotine)
  8. Currently pregnant or lactating
  9. Shift work employment schedule within the prior 6-months
  10. Have engaged in ≥5 sessions of HITT or resistance training within the past 12-months
  11. History of treatment with antipsychotic medications
  12. Current participation in psychosocial treatment for substance use disorder
  13. Other psychoactive medications or psychosocial treatments will be considered on a case-by-case basis. Where a current psychoactive medication is deemed acceptable, both dose and type must have been stable for a minimum of four weeks prior to baseline assessment, and remain stable throughout the 12-week exercise phase of the study.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Low Intensity Physical TrainingStrength and Resistance Training12- week, 36 session, strength-focussed physical exercise program delivered by an accredited exercise physiologist
High Intensity Physical TrainingHigh Intensity Interval Training12-week, 36 session, cardiorespiratory-focussed physical exercise program delivered by an accredited exercise physiologist
Primary Outcome Measures
NameTimeMethod
Change in hippocampal integrityBaseline (0 months), post (3 months)

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.

Secondary Outcome Measures
NameTimeMethod
Change in anxiety symptomsBaseline (0 months), post (3 months), follow up (6 months)

StateTrait Anxiety Inventory (STAI; range = 20 to 80, higher scores indicate greater anxiety)

Change in resilienceBaseline (0 months), post (3 months), follow up (6 months)

Connor David Resilience Scale (CDRS; range = 0-100 higher scores indicate higher resilience)

Change in sleep qualityBaseline (0 months), post (3 months), follow up (6 months)

Pittsburgh Sleep Quality Index (PSQI; range = 0 to 21 higher scores indicate worse sleep quality)

Change in associative memoryBaseline (0 months), post (3 months), follow up (6 months)

Paired Associates Learning Task (PAL)

Change in memoryBaseline (0 months), post (3 months), follow up (6 months)

Rey Auditory Verbal Learning Test (RAVLT)

Change in cannabis dependenceBaseline (0 months), post (3 months), follow up (6 months)

Severity of Dependence Scale (SDS; range = 0-15 higher scores indicate higher dependence

Change in quality of lifeBaseline (0 months), post (3 months), follow up (6 months)

Quality of Life and Satisfaction Questionnaire - Short Form (QOL-SF; range = 70 higher scores indicate greater life satisfaction and enjoyment)

Change in cardiorespiratory fitnessBaseline (0 months), post (3 months)

VO2 max

Change in cannabis useBaseline (0 months), post (3 months), follow up (6 months)

Time line follow back

Change in cannabis cravingBaseline (0 months), post (3 months), follow up (6 months)

Penn Craving Scale (PCS; range = 0 - 30 higher scores indicate greater craving)

Change in coping skillsBaseline (0 months), post (3 months), follow up (6 months)

Perceived Stress Scale (10 item; range = 0 - 40 higher scores indicate greater stress)

Change in depression symptomsBaseline (0 months), post (3 months), follow up (6 months)

Quick Inventory of Depressive Symptomology (QUIDS; range = 0 - 27 higher scores indicate greater depression symptom severity)

Change in mental wellbeingBaseline (0 months), post (3 months), follow up (6 months)

Warwick Edinburgh Mental Wellbeing Scale (WEMWBS; range = 14-70 higher scores indicate increased mental well being)

Change in visual memoryBaseline (0 months), post (3 months)

Figural Memory Tasks

Trial Locations

Locations (1)

Monash University, BrainPark

🇦🇺

Melbourne, Victoria, Australia

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