Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04902092
Registration number
NCT04902092
Ethics application status
Date submitted
13/05/2021
Date registered
26/05/2021
Titles & IDs
Public title
Brain Exercise and Addiction Trial
Query!
Scientific title
Brain Exercise and Addiction Trial: Efficacy of a 12-week Aerobic Exercise Regime for Restoring 'Brain Health' in Cannabis Users
Query!
Secondary ID [1]
0
0
12563
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
BEAT
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cannabis Use Disorder, Moderate
0
0
Query!
Cannabis Use Disorder, Severe
0
0
Query!
Condition category
Condition code
Mental Health
0
0
0
0
Query!
Addiction
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
BEHAVIORAL - High Intensity Interval Training
BEHAVIORAL - 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
BEHAVIORAL: 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.
BEHAVIORAL: 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).
Query!
Intervention code [1]
0
0
BEHAVIORAL
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change in hippocampal integrity
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline (0 months), post (3 months)
Query!
Secondary outcome [1]
0
0
Change in cannabis use
Query!
Assessment method [1]
0
0
Time line follow back
Query!
Timepoint [1]
0
0
Baseline (0 months), post (3 months), follow up (6 months)
Query!
Secondary outcome [2]
0
0
Change in cannabis dependence
Query!
Assessment method [2]
0
0
Severity of Dependence Scale (SDS; range = 0-15 higher scores indicate higher dependence
Query!
Timepoint [2]
0
0
Baseline (0 months), post (3 months), follow up (6 months)
Query!
Secondary outcome [3]
0
0
Change in cannabis craving
Query!
Assessment method [3]
0
0
Penn Craving Scale (PCS; range = 0 - 30 higher scores indicate greater craving)
Query!
Timepoint [3]
0
0
Baseline (0 months), post (3 months), follow up (6 months)
Query!
Secondary outcome [4]
0
0
Change in depression symptoms
Query!
Assessment method [4]
0
0
Quick Inventory of Depressive Symptomology (QUIDS; range = 0 - 27 higher scores indicate greater depression symptom severity)
Query!
Timepoint [4]
0
0
Baseline (0 months), post (3 months), follow up (6 months)
Query!
Secondary outcome [5]
0
0
Change in anxiety symptoms
Query!
Assessment method [5]
0
0
StateTrait Anxiety Inventory (STAI; range = 20 to 80, higher scores indicate greater anxiety)
Query!
Timepoint [5]
0
0
Baseline (0 months), post (3 months), follow up (6 months)
Query!
Secondary outcome [6]
0
0
Change in resilience
Query!
Assessment method [6]
0
0
Connor David Resilience Scale (CDRS; range = 0-100 higher scores indicate higher resilience)
Query!
Timepoint [6]
0
0
Baseline (0 months), post (3 months), follow up (6 months)
Query!
Secondary outcome [7]
0
0
Change in coping skills
Query!
Assessment method [7]
0
0
Perceived Stress Scale (10 item; range = 0 - 40 higher scores indicate greater stress)
Query!
Timepoint [7]
0
0
Baseline (0 months), post (3 months), follow up (6 months)
Query!
Secondary outcome [8]
0
0
Change in sleep quality
Query!
Assessment method [8]
0
0
Pittsburgh Sleep Quality Index (PSQI; range = 0 to 21 higher scores indicate worse sleep quality)
Query!
Timepoint [8]
0
0
Baseline (0 months), post (3 months), follow up (6 months)
Query!
Secondary outcome [9]
0
0
Change in mental wellbeing
Query!
Assessment method [9]
0
0
Warwick Edinburgh Mental Wellbeing Scale (WEMWBS; range = 14-70 higher scores indicate increased mental well being)
Query!
Timepoint [9]
0
0
Baseline (0 months), post (3 months), follow up (6 months)
Query!
Secondary outcome [10]
0
0
Change in quality of life
Query!
Assessment method [10]
0
0
Quality of Life and Satisfaction Questionnaire - Short Form (QOL-SF; range = 70 higher scores indicate greater life satisfaction and enjoyment)
Query!
Timepoint [10]
0
0
Baseline (0 months), post (3 months), follow up (6 months)
Query!
Secondary outcome [11]
0
0
Change in memory
Query!
Assessment method [11]
0
0
Rey Auditory Verbal Learning Test (RAVLT)
Query!
Timepoint [11]
0
0
Baseline (0 months), post (3 months), follow up (6 months)
Query!
Secondary outcome [12]
0
0
Change in associative memory
Query!
Assessment method [12]
0
0
Paired Associates Learning Task (PAL)
Query!
Timepoint [12]
0
0
Baseline (0 months), post (3 months), follow up (6 months)
Query!
Secondary outcome [13]
0
0
Change in visual memory
Query!
Assessment method [13]
0
0
Figural Memory Tasks
Query!
Timepoint [13]
0
0
Baseline (0 months), post (3 months)
Query!
Secondary outcome [14]
0
0
Change in cardiorespiratory fitness
Query!
Assessment method [14]
0
0
VO2 max
Query!
Timepoint [14]
0
0
Baseline (0 months), post (3 months)
Query!
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'
Query!
Minimum age
20
Years
Query!
Query!
Maximum age
55
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
23/01/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
21/11/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
65
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Monash University, BrainPark - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3800 - Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Monash University
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Turning Point
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04902092
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Murat Yucel
Query!
Address
0
0
Monash University
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04902092