Dronabinol for Chronic Low Back Pain
This study is exploring if dronabinol (a synthetic form of THC, the active ingredient in cannabis, also known as Marinol) can help reduce chronic low back pain. Researchers want to see if it's safe enough to consider for larger studies in the future. You might be eligible if you are 18-64 years old and have ongoing low back pain. Participants will receive either dronabinol or a placebo (an inactive substance) for 8 weeks. The main goals are to measure changes in your pain intensity and to track any side effects you might experience. The study aims to enroll up to 75 people, but its current recruitment status is unclear.
- Study design
- This is a double-blind, placebo-controlled, randomized study where participants and researchers won't know who is receiving dronabinol and who is receiving the placebo. Up to 75 participants will be enrolled.
- What's involved
- Participants will take oral medication daily for 8 weeks, with the dose gradually increasing as needed. Pain intensity and adverse events will be monitored.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pain intensity and safety will be monitored from the start of the study until 8 weeks later.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Dronabinol as an Adjunct for Reducing Pain
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Christopher D Verrico, phD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
Who to contact
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What this trial measures
- Pain IntensityBaseline to 8-weeks
For change in pain intensity from baseline to 8-weeks, the investigators will estimate the mean within each arm using the Research Standards for Chronic Low-Back Pain (RScLBP).
- Safety Analysis - Adverse Events (AEs)Baseline to 8-weeks
AEs will be coded using the most recent version of the Medical Dictionary of Regulatory Activities (MedDRA) preferred terms and will be grouped by system, organ, and class (SOC) designation. The severity, frequency, and relationship of AEs to investigational product will be presented by preferred term by SOC grouping. Listings of each individual AE including start date, stop date, severity, relationship, outcome, and duration will be provided.