Brain Exercise and Addiction Trial

Cannabis Use Disorder, Moderate Clinical Trial

— BEAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04902092
• Other study ID #: 12563
• Status: Completed
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: November 21, 2022

Study information

• Verified date: October 2023
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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. 1. 12 weeks of regular HIIT exercise 2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 21, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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'

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.

Related Conditions & MeSH terms

• Cannabis Use Disorder, Moderate
• Cannabis Use Disorder, Severe
• Marijuana Abuse

Intervention

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.
• 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).

Locations

Country	Name	City	State
Australia	Monash University, BrainPark	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Monash University	Turning Point

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	Change in cannabis use	Time line follow back	Baseline (0 months), post (3 months), follow up (6 months)
Secondary	Change in cannabis dependence	Severity of Dependence Scale (SDS; range = 0-15 higher scores indicate higher dependence	Baseline (0 months), post (3 months), follow up (6 months)
Secondary	Change in cannabis craving	Penn Craving Scale (PCS; range = 0 - 30 higher scores indicate greater craving)	Baseline (0 months), post (3 months), follow up (6 months)
Secondary	Change in depression symptoms	Quick Inventory of Depressive Symptomology (QUIDS; range = 0 - 27 higher scores indicate greater depression symptom severity)	Baseline (0 months), post (3 months), follow up (6 months)
Secondary	Change in anxiety symptoms	StateTrait Anxiety Inventory (STAI; range = 20 to 80, higher scores indicate greater anxiety)	Baseline (0 months), post (3 months), follow up (6 months)
Secondary	Change in resilience	Connor David Resilience Scale (CDRS; range = 0-100 higher scores indicate higher resilience)	Baseline (0 months), post (3 months), follow up (6 months)
Secondary	Change in coping skills	Perceived Stress Scale (10 item; range = 0 - 40 higher scores indicate greater stress)	Baseline (0 months), post (3 months), follow up (6 months)
Secondary	Change in sleep quality	Pittsburgh Sleep Quality Index (PSQI; range = 0 to 21 higher scores indicate worse sleep quality)	Baseline (0 months), post (3 months), follow up (6 months)
Secondary	Change in mental wellbeing	Warwick Edinburgh Mental Wellbeing Scale (WEMWBS; range = 14-70 higher scores indicate increased mental well being)	Baseline (0 months), post (3 months), follow up (6 months)
Secondary	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)	Baseline (0 months), post (3 months), follow up (6 months)
Secondary	Change in memory	Rey Auditory Verbal Learning Test (RAVLT)	Baseline (0 months), post (3 months), follow up (6 months)
Secondary	Change in associative memory	Paired Associates Learning Task (PAL)	Baseline (0 months), post (3 months), follow up (6 months)
Secondary	Change in visual memory	Figural Memory Tasks	Baseline (0 months), post (3 months)
Secondary	Change in cardiorespiratory fitness	VO2 max	Baseline (0 months), post (3 months)