Brain Exercise and Addiction Trial
BEAT
BEAT
Sponsor study identifier
interventional
65
1 country
1
Study Start
January 23, 2019
Actual (reported)Primary Completion
June 10, 2022
Actual (reported)Study Completion
November 21, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 21, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 23, 2019
Actual (reported)May 13, 2021
Actual (reported)May 26, 2021
Actual (reported)June 10, 2022
Actual (reported)November 21, 2022
Actual (reported)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.
Baseline (0 months), post (3 months)
Change in cannabis use
Baseline (0 months), post (3 months), follow up (6 months)
Change in cannabis dependence
Baseline (0 months), post (3 months), follow up (6 months)
Change in cannabis craving
Baseline (0 months), post (3 months), follow up (6 months)
Change in depression symptoms
Baseline (0 months), post (3 months), follow up (6 months)
Change in anxiety symptoms
Baseline (0 months), post (3 months), follow up (6 months)
12-week, 36 session, cardiorespiratory-focussed physical exercise program delivered by an accredited exercise physiologist
12- week, 36 session, strength-focussed physical exercise program delivered by an accredited exercise physiologist
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.
Monash University, BrainPark
Melbourne, Victoria, 3800, Australia
Richardson KE, Suo C, Albertella L, Maleki S, Coxon J, Hendrikse J, Hughes S, Pitt J, Kayayan E, Brown C, Nguyen L, Solowij N, Lubman DI, Segrave R, Yucel M. High-Intensity Exercise and Hippocampal Integrity in Adults With Cannabis Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Dec 1;82(12):1240-1245. doi: 10.1001/jamapsychiatry.2025.2319.
Murat Yucel
Monash University
65 participants (actual enrollment reported by the registry).
First Submitted
May 13, 2021
First Posted
May 26, 2021
Study Start
January 23, 2019
Actual (reported)Cannabis and Processing Emotions Study
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).
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Primary Completion
June 10, 2022
Actual (reported)Study Completion
November 21, 2022
Actual (reported)Last Updated
October 23, 2023
Record last verified: 2023-10
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Source: ClinicalTrials.gov.
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