Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000593639
Ethics application status
Approved
Date submitted
17/05/2023
Date registered
31/05/2023
Date last updated
4/04/2024
Date data sharing statement initially provided
31/05/2023
Date results provided
4/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Does cannabidiol enhance exercise enjoyment? A randomised controlled trial.
Scientific title
The effect of cannabidiol on affective responses to self-paced aerobic exercise in healthy adults: A randomised, double-blind, placebo-controlled, crossover trial.
Secondary ID [1] 309567 0
None
Secondary ID [2] 310060 0
CT-2023-CTN-02338-1
Universal Trial Number (UTN)
U1111-1292-7055
Trial acronym
Linked study record
The current study is a follow-up to ACTRN12620000941965.

Health condition
Health condition(s) or problem(s) studied:
Physical Inactivity 330035 0
Condition category
Condition code
Physical Medicine / Rehabilitation 326943 326943 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be 150 mg of cannabidiol (CBD). Specifically, it will be 2 x soft-gel capsules each containing 75 mg CBD in an oil-based formulation. The capsules will be consumed (once only) via oral ingestion under the supervision of an investigator 90 minutes prior to exercise.

The exercise task will be a supervised 25-lap (i.e., ~10 km) run on a standard, outdoor athletics track. Each participant will complete two runs – one after each treatment (i.e., CBD and placebo). The runs will be self-paced with participants instructed to minimise the amount of walking they do and run to the same self-selected 'goal' (i.e., either: (a) as fast as possible, (b) as fast as is comfortably possible or (c) at a tolerable pace) on each occasion. They will also be completed in large groups with participants instructed to run in the same ‘social context’ (i.e., either: (a) predominantly alone or (b) predominantly with one partner) on each occasion. Participants will be instructed not to listen to music or consume fluid throughout exercise.

The washout period between treatments will be greater than or equal to 7 days.
Intervention code [1] 326118 0
Treatment: Drugs
Comparator / control treatment
The control will be a placebo. Specifically, it will be 2 x soft-gel capsules containing an oil-based formulation (only). The capsules will not contain any cannabinoids or other cannabis constituents.
Control group
Placebo

Outcomes
Primary outcome [1] 334779 0
Affective Valence during exercise as assessed using the 'Feelings Scale'.
Timepoint [1] 334779 0
2.4 km (6 laps), 4.8 km (12 laps), 7.2 km (18 laps) and 9.6 km (24 laps) of running.

Note: The ratings obtained at the 9.6 km 'timepoint' will be handled with care as they may be confounded by the expectation of soon finishing exercise.
Primary outcome [2] 334780 0
Positive Affect at rest as assessed using the 'Positive and Negative Affect Schedule'.
Timepoint [2] 334780 0
Baseline, Pre-Exercise (i.e., ~90 minutes post-treatment), and shortly (i.e., <15 minutes) Post-Exercise.
Primary outcome [3] 334865 0
Negative Affect at rest as assessed using the 'Positive and Negative Affect Schedule'.
Timepoint [3] 334865 0
Baseline, Pre-Exercise (i.e., ~90 minutes post-treatment), and shortly (i.e., <15 minutes) Post-Exercise.
Secondary outcome [1] 422059 0
Exercise Enjoyment as assessed using the 'Physical Activity Enjoyment Scale'.
Timepoint [1] 422059 0
Shortly (i.e., <15 minutes) Post-Exercise.
Secondary outcome [2] 422060 0
Exercise Motivation as assessed using a 100 mm Visual Analog Scale.
Timepoint [2] 422060 0
Shortly (i.e., <15 minutes) Post-Exercise.
Secondary outcome [3] 422061 0
Exercise Self-Efficacy as assessed using a 100 mm Visual Analog Scale.
Timepoint [3] 422061 0
Shortly (i.e., <15 minutes) Post-Exercise.
Secondary outcome [4] 422064 0
Run time
Timepoint [4] 422064 0
Measured from start of run to completion of 25 laps.
Secondary outcome [5] 422065 0
Perceived Exertion during exercise as assessed using the 'Borg Scale'.
Timepoint [5] 422065 0
2.4 km (6 laps), 4.8 km (12 laps), 7.2 km (18 laps) and 9.6 km (24 laps) of running.
Secondary outcome [6] 422286 0
The Euphoria component of the 'Runner's High' as assessed using a 100 mm Visual Analog Scale.
Timepoint [6] 422286 0
Baseline, Pre-Exercise (i.e., ~90 minutes post-treatment), and shortly (i.e., <15 minutes) Post-Exercise.
Secondary outcome [7] 422287 0
The Pain component of the 'Runner's High' as assessed using a 100 mm Visual Analog Scale.
Timepoint [7] 422287 0
Baseline, Pre-Exercise (i.e., ~90 minutes post-treatment), and shortly (i.e., <15 minutes) Post-Exercise.
Secondary outcome [8] 422288 0
The Anxiety component of the 'Runner's High' as assessed using a 100 mm Visual Analog Scale.
Timepoint [8] 422288 0
Baseline, Pre-Exercise (i.e., ~90 minutes post-treatment), and shortly (i.e., <15 minutes) Post-Exercise.
Secondary outcome [9] 422289 0
The Sedation component of the 'Runner's High' as assessed using a 100 mm Visual Analog Scale.
Timepoint [9] 422289 0
Baseline, Pre-Exercise (i.e., ~90 minutes post-treatment), and shortly (i.e., <15 minutes) Post-Exercise.

Eligibility
Key inclusion criteria
(a) Greater than or equal to 18 years of age
(b) Able to perform aerobic exercise as assessed using the ‘Physical Activity Readiness Questionnaire for Everyone ’ (PAR-Q+).
(c) Proficient in English (i.e., able to provide informed consent).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(a) A self-reported history of allergic reaction to cannabis or cannabinoid-containing products
(b) A self-reported history of liver disease or renal disease
(c) A self-reported or physician-suspected history of drug/alcohol dependence (excluding nicotine dependence)
(d) Current suicide ideation (i.e., a score >0 on Question 9 of the 'Patient Health Questionnaire' or at the physician's discretion)
(e) Regular (i.e., more than twice weekly) use of cannabis or CBD
(f) Unwilling to adhere to trial procedures
(g) Pregnant, lactating, or trying to conceive.

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)
Allocation will be concealed using numbered containers (or 'sachets').

Each participant will be assigned a unique Randomisation Code (e.g., R001, R002, R003, etc.) that is linked to two sachets (e.g., labeled R001-Session 1 and R001-Session 2) carrying their assigned treatments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary Outcome #1: Feelings Scale (FS) ratings will be analysed using linear mixed effects models that include Treatment, Time, and the Treatment × Time interaction as fixed effects and the participant (crossed by treatment) as a random effect. A priori planned pairwise comparisons of FS ratings on CBD versus placebo at the 6-, 12- and 18-lap ‘timepoints’ will also be performed. (Note: The ratings obtained at the 24-lap 'timepoint' will be handled with care as they may be confounded by the expectation of soon finishing exercise).

Primary Outcome #2: Total ‘Positive’ and ‘Negative’ scores on the Positive and Negative Affect Schedule will be calculated and analysed using linear mixed effects models (as described above). Bonferroni corrected pairwise comparisons will be used to compare the estimated marginal means by Treatment if a relevant main effect or interaction is observed.

The secondary outcomes will be analysed using linear mixed effects models. Treatment, Time, and the Treatment × Time interaction will be included as fixed effects (as applicable) and the participant (crossed by treatment) will be included as a random effect. Bonferroni corrected pairwise comparisons will be used to compare the estimated marginal means on CBD versus placebo if a relevant main effect or interaction is observed. Statistical significance will be accepted as p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/07/2023
Actual
17/07/2023
Date of last participant enrolment
Anticipated
21/08/2023
Actual
1/08/2023
Date of last data collection
Anticipated
28/08/2023
Actual
28/08/2023
Sample size
Target
120
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 313756 0
Other
Name [1] 313756 0
Lambert Initiative for Cannabinoid Therapeutics
Country [1] 313756 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 315712 0
None
Name [1] 315712 0
Address [1] 315712 0
Country [1] 315712 0
Other collaborator category [1] 282682 0
University
Name [1] 282682 0
Griffith University
Address [1] 282682 0
Parklands Drive, Southport QLD 4215
Country [1] 282682 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312927 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 312927 0
Ethics committee country [1] 312927 0
Australia
Date submitted for ethics approval [1] 312927 0
25/01/2023
Approval date [1] 312927 0
24/04/2023
Ethics approval number [1] 312927 0
2023/253

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126366 0
Dr Danielle McCartney
Address 126366 0
The University of Sydney
Brain and Mind Centre
94 Mallett Street, Camperdown NSW 2050
Country 126366 0
Australia
Phone 126366 0
+61 2 8627 8818
Fax 126366 0
Email 126366 0
[email protected]
Contact person for public queries
Name 126367 0
Danielle McCartney
Address 126367 0
The University of Sydney
Brain and Mind Centre
94 Mallett Street, Camperdown NSW 2050
Country 126367 0
Australia
Phone 126367 0
+61 2 8627 8818
Fax 126367 0
Email 126367 0
[email protected]
Contact person for scientific queries
Name 126368 0
Danielle McCartney
Address 126368 0
The University of Sydney
Brain and Mind Centre
94 Mallett Street, Camperdown NSW 2050
Country 126368 0
Australia
Phone 126368 0
+61 2 8627 8818
Fax 126368 0
Email 126368 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial (in non-identifiable form).
When will data be available (start and end dates)?
Start: Immediately following publication; End: 15 years from the day the study is completed.
Available to whom?
Researchers (upon reasonable request).
Available for what types of analyses?
Meta-analyses.
How or where can data be obtained?
The Principal Investigator ([email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.