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Brain Exercise and Addiction Trial (BEAT)

Primary Purpose

Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe

Status

Completed

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

High Intensity Interval Training

Strength and Resistance Training

About this trial

This is an interventional treatment trial for Cannabis Use Disorder, Moderate

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Monash University, BrainPark

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

High Intensity Physical Training

Low Intensity Physical Training

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in cannabis use

Time line follow back

Change in cannabis dependence

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

Change in cannabis craving

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

Change in depression symptoms

Quick Inventory of Depressive Symptomology (QUIDS; range = 0 - 27 higher scores indicate greater depression symptom severity)

Change in anxiety symptoms

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

Change in resilience

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

Change in coping skills

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

Change in sleep quality

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

Change in mental wellbeing

Warwick Edinburgh Mental Wellbeing Scale (WEMWBS; range = 14-70 higher scores indicate increased mental well being)

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)

Change in memory

Rey Auditory Verbal Learning Test (RAVLT)

Change in associative memory

Paired Associates Learning Task (PAL)

Change in visual memory

Figural Memory Tasks

Change in cardiorespiratory fitness

VO2 max

Full Information

NCT ID

NCT04902092

First Posted

May 13, 2021

Last Updated

October 18, 2023

Sponsor

Monash University

Collaborators

Turning Point

1. Study Identification

Unique Protocol Identification Number

NCT04902092

Brief Title

Brain Exercise and Addiction Trial

Acronym

BEAT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

January 23, 2019 (Actual)

Primary Completion Date

June 10, 2022 (Actual)

Study Completion Date

November 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Monash University

Collaborators

Turning Point

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High Intensity Physical Training

Arm Type

Active Comparator

Arm Description

12-week, 36 session, cardiorespiratory-focussed physical exercise program delivered by an accredited exercise physiologist

Arm Title

Low Intensity Physical Training

Arm Type

Active Comparator

Arm Description

12- week, 36 session, strength-focussed physical exercise program delivered by an accredited exercise physiologist

Intervention Type

Behavioral

Intervention Name(s)

High Intensity Interval Training

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Strength and Resistance Training

Intervention Description

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 Outcome Measure Information:

Title

Change in hippocampal integrity

Description

Time Frame

Baseline (0 months), post (3 months)

Secondary Outcome Measure Information:

Title

Change in cannabis use

Description

Time line follow back

Time Frame