Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04902092




Registration number
NCT04902092
Ethics application status
Date submitted
13/05/2021
Date registered
26/05/2021
Date last updated
23/10/2023

Titles & IDs
Public title
Brain Exercise and Addiction Trial
Scientific title
Brain Exercise and Addiction Trial: Efficacy of a 12-week Aerobic Exercise Regime for Restoring 'Brain Health' in Cannabis Users
Secondary ID [1] 0 0
12563
Universal Trial Number (UTN)
Trial acronym
BEAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cannabis Use Disorder, Moderate 0 0
Cannabis Use Disorder, Severe 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - High Intensity Interval Training
Behaviour - Strength and Resistance Training

Active Comparator: High Intensity Physical Training - 12-week, 36 session, cardiorespiratory-focussed physical exercise program delivered by an accredited exercise physiologist

Active Comparator: Low Intensity Physical Training - 12- week, 36 session, strength-focussed physical exercise program delivered by an accredited exercise physiologist


Behaviour: High Intensity Interval 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.

Behaviour: Strength and Resistance Training
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).
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in hippocampal integrity
Timepoint [1] 0 0
Baseline (0 months), post (3 months)
Secondary outcome [1] 0 0
Change in cannabis use
Timepoint [1] 0 0
Baseline (0 months), post (3 months), follow up (6 months)
Secondary outcome [2] 0 0
Change in cannabis dependence
Timepoint [2] 0 0
Baseline (0 months), post (3 months), follow up (6 months)
Secondary outcome [3] 0 0
Change in cannabis craving
Timepoint [3] 0 0
Baseline (0 months), post (3 months), follow up (6 months)
Secondary outcome [4] 0 0
Change in depression symptoms
Timepoint [4] 0 0
Baseline (0 months), post (3 months), follow up (6 months)
Secondary outcome [5] 0 0
Change in anxiety symptoms
Timepoint [5] 0 0
Baseline (0 months), post (3 months), follow up (6 months)
Secondary outcome [6] 0 0
Change in resilience
Timepoint [6] 0 0
Baseline (0 months), post (3 months), follow up (6 months)
Secondary outcome [7] 0 0
Change in coping skills
Timepoint [7] 0 0
Baseline (0 months), post (3 months), follow up (6 months)
Secondary outcome [8] 0 0
Change in sleep quality
Timepoint [8] 0 0
Baseline (0 months), post (3 months), follow up (6 months)
Secondary outcome [9] 0 0
Change in mental wellbeing
Timepoint [9] 0 0
Baseline (0 months), post (3 months), follow up (6 months)
Secondary outcome [10] 0 0
Change in quality of life
Timepoint [10] 0 0
Baseline (0 months), post (3 months), follow up (6 months)
Secondary outcome [11] 0 0
Change in memory
Timepoint [11] 0 0
Baseline (0 months), post (3 months), follow up (6 months)
Secondary outcome [12] 0 0
Change in associative memory
Timepoint [12] 0 0
Baseline (0 months), post (3 months), follow up (6 months)
Secondary outcome [13] 0 0
Change in visual memory
Timepoint [13] 0 0
Baseline (0 months), post (3 months)
Secondary outcome [14] 0 0
Change in cardiorespiratory fitness
Timepoint [14] 0 0
Baseline (0 months), post (3 months)

Eligibility
Key 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'
Minimum age
20 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/11/2022
Sample size
Target
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University, BrainPark - Melbourne
Recruitment postcode(s) [1] 0 0
3800 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Turning Point
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04902092
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Murat Yucel
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04902092