Cannabis Use Disorder, ModerateBEATNCT04902092
Brain Exercise and Addiction Trial
A study testing High Intensity Interval Training and Strength and Resistance Training in people with Cannabis Use Disorder, Moderate and Cannabis Use Disorder, Severe, run by Monash University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe
- What is being tested?
- High Intensity Interval Training and Strength and Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteAustralia
- Study dates
- 23 Jan 2019to 21 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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'
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Exercise and Addiction Trial: Efficacy of a 12-week Aerobic Exercise Regime for Restoring 'Brain Health' in 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. 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.
Read the 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.
- 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.
- Being tested
- High Intensity Interval Training, Strength and Resistance Training
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingBehavioural
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 TrainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Physical Training | Active comparator | 12-week, 36 session, cardiorespiratory-focussed physical exercise program delivered by an accredited exercise physiologist Receives: Behavioral: High Intensity Interval Training |
| Low Intensity Physical Training | Active comparator | 12- week, 36 session, strength-focussed physical exercise program delivered by an accredited exercise physiologist Receives: Behavioral: Strength and Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (0 months), post (3 months)
Secondary outcomes (14)
Change in cannabis use
Time line follow back
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline (0 months), post (3 months), follow up (6 months)
Change in memory
Rey Auditory Verbal Learning Test (RAVLT)
Measured: Baseline (0 months), post (3 months), follow up (6 months)
Change in associative memory
Paired Associates Learning Task (PAL)
Measured: Baseline (0 months), post (3 months), follow up (6 months)
Change in visual memory
Figural Memory Tasks
Measured: Baseline (0 months), post (3 months)
Change in cardiorespiratory fitness
VO2 max
Measured: Baseline (0 months), post (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start23 Jan 2019
- Primary completion10 Jun 2022
- Study completion21 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis Use Disorder, ModerateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Turning Point
- Responsible party
- Principal investigator, Rebecca Segrave, Monash University
- Investigators
- Murat Yucel, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902092
- Sponsor's protocol ID
- 12563
- Acronym
- BEAT
- Status last verified
- Oct 2023
- First submitted
- 13 May 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40928796
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Exercise and Addiction Trial: Efficacy of a 12-week Aerobic Exercise Regime for Restoring 'Brain Health' in Cannabis Users
- ClinicalTrials.gov ID
- NCT04902092
- Acronym / sponsor ID
- BEAT / 12563
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- Turning Point
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Physical Training | Active comparator | Behavioral: High Intensity Interval Training12-week, 36 session, cardiorespiratory-focussed physical exercise program delivered by an accredited exercise physiologist |
| Low Intensity Physical Training | Active comparator | Behavioral: Strength and Resistance Training12- week, 36 session, strength-focussed physical exercise program delivered by an accredited exercise physiologist |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval TrainingExercise 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. | Behavioural | High Intensity Physical Training |
| Strength and Resistance TrainingExercise 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). | Behavioural | Low Intensity Physical Training |
Primary outcome
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.
14 secondary outcomes
Change in cannabis use
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in cannabis dependence
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in cannabis craving
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in depression symptoms
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in anxiety symptoms
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in resilience
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in coping skills
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in sleep quality
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in mental wellbeing
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in quality of life
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in memory
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in associative memory
Time frame: Baseline (0 months), post (3 months), follow up (6 months)
Change in visual memory
Time frame: Baseline (0 months), post (3 months)
Change in cardiorespiratory fitness
Time frame: Baseline (0 months), post (3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 40928796Richardson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murat Yucel principal investigator
Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training and Strength and Resistance Training in people with Cannabis Use Disorder, Moderate and Cannabis Use Disorder, Severe, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hippocampal integrity (time frame: Baseline (0 months), post (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04902092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.