Clinical trial
Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC): Effectiveness, Side Effects and Neurobiological Changes
Name
IRB_00103451
Description
This is a study comparing the effects of Delta-9-Tetrahydrocannabinol (THC) versus Cannabidiol (CBD) versus a placebo on chronic non-cancer pain.
Trial arms
Trial start
2018-02-01
Estimated PCD
2024-12-30
Trial end
2025-03-01
Status
Recruiting
Phase
Early phase I
Treatment
Delta-9-Tetrahydrocannabinol
An oral dose of Delta-9-Tetrahydrocannabinol (THC) will be given once a day for five day with pain ratings taken before and after each dose every day.
Arms:
Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on pain
Other names:
THC, Delta-9-THC
Cannabidiol
An oral dose of Cannabidiol (CBD) will be given once a day for five day with pain ratings taken before and after each dose every day.
Arms:
Cannabidiol's (CBD) effects on pain
Other names:
CBD
Placebos
An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day.
Arms:
Placebo
Other names:
placebo
Size
75
Primary endpoint
Brain Changes
5 days
Eligibility criteria
Inclusion criteria:
1. Age between 18-50 yrs.
2. History of cannabis use.
3. Chronic musculoskeletal and joint pain for at least 3 months or longer.
4. Participants must live within a 60 mile radius of Salt Lake City, Utah to be eligible.
Exclusion criteria:
1. Current or past neurological illness.
2. Substance abuse or dependence within the prior 60 days.
3. Contraindication to brain MRI.
4. Type I and type II diabetes.
5. Unstable medical conditions.
6. Consumption of more than 2 drinks of alcohol per night.
7. Current pregnancy or planning to become pregnant or breastfeeding
8. History of seizures or head trauma
9. Active or history of major mental illness
10. LFT results 3 times greater than the upper limit of normal at screening.
11. Participants may be excluded if the PI feels they do not meet safety criteria.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}
Updated at
2024-04-26
1 organization
Organization
University of Utah