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Completed

NCT Number: NCT04902092

Brain Exercise and Addiction Trial

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.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monash University, BrainPark

Melbourne, Victoria, 3800, Australia

About this study

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.

  • 12 weeks of regular HIIT exercise
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 20-55 years
  • Voluntary and able to provide informed consent
  • Fluent in English
  • Current moderate - severe cannabis use disorder
  • Major history of cannabis use (i.e. ≥3 days per week on average for ≥4 of the past 6 years)
  • Capacity to tolerate physical exercise according to 'Fitness to Exercise'

Exclusion criteria

  • 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
  • Severe claustrophobia, non-MR compatible metallic implant, or other contraindication to MRI scanning
  • Lifetime history of significant neurological illness, or moderate - severe brain injury,
  • Current major unstable medical illness or chronic pain condition
  • Lifetime history of schizophrenia, schizoaffective disorder, OCD, PTSD, bipolar disorder
  • Current significant depression or anxiety that precludes ability to reliably engage in the exercise program
  • Current moderate - severe substance use disorder for substances other than cannabis (excluding nicotine)
  • Currently pregnant or lactating
  • Shift work employment schedule within the prior 6-months
  • Have engaged in ≥5 sessions of HITT or resistance training within the past 12-months
  • History of treatment with antipsychotic medications
  • Current participation in psychosocial treatment for substance use disorder
  • 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.

Treatment and study plan

High Intensity Interval Training

Behavioral

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.

Strength and Resistance Training

Behavioral

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).

Primary outcomes

  1. Change in hippocampal integrity

    Time frame: Baseline (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 outcomes

  1. Change in cannabis use

    Time frame: Baseline (0 months), post (3 months), follow up (6 months)

    Time line follow back

  2. Change in cannabis dependence

    Time frame: Baseline (0 months), post (3 months), follow up (6 months)

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

  3. Change in cannabis craving

    Time frame: Baseline (0 months), post (3 months), follow up (6 months)

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

  4. Change in depression symptoms

    Time frame: Baseline (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)

  5. Change in anxiety symptoms

    Time frame: Baseline (0 months), post (3 months), follow up (6 months)

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

  6. Change in resilience

    Time frame: Baseline (0 months), post (3 months), follow up (6 months)

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

  7. Change in coping skills

    Time frame: Baseline (0 months), post (3 months), follow up (6 months)

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

  8. Change in sleep quality

    Time frame: Baseline (0 months), post (3 months), follow up (6 months)

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

  9. Change in mental wellbeing

    Time frame: Baseline (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)

  10. Change in quality of life

    Time frame: Baseline (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)

  11. Change in memory

    Time frame: Baseline (0 months), post (3 months), follow up (6 months)

    Rey Auditory Verbal Learning Test (RAVLT)

  12. Change in associative memory

    Time frame: Baseline (0 months), post (3 months), follow up (6 months)

    Paired Associates Learning Task (PAL)

  13. Change in visual memory

    Time frame: Baseline (0 months), post (3 months)

    Figural Memory Tasks

  14. Change in cardiorespiratory fitness

    Time frame: Baseline (0 months), post (3 months)

    VO2 max

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • Turning Point

Registry information

Official study title

Brain Exercise and Addiction Trial: Efficacy of a 12-week Aerobic Exercise Regime for Restoring 'Brain Health' in Cannabis Users

Acronym: BEAT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 26, 2021
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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