A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Explore the Safety and Therapeutic Potential of Dronabinol as an Adjunct for Reducing Pain
Christopher D. Verrico
Summary
This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol \[dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)\] for chronic low back pain (cLBP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg/day), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study.
Description
Musculoskeletal pain can be due to an injury to the bones, joints, muscles, tendons, ligaments, or nerves, which can be caused by jerking movements, car accidents, falls, fractures, sprains, dislocations, and direct blows to the muscle. Musculoskeletal pain can be localized in one area, or widespread. Lower back pain is the most common type of musculoskeletal pain. Other common types include tendonitis, myalgia (muscle pain), and stress fractures. A review of opioids for non-cancer musculoskeletal diseases concluded that opioids were "only slightly more effective than their placebos, no more e…
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Ability to take oral medication per protocol. 4. Male or female, aged 18-64 years. 5. Has chronic low back pain (i.e., in the space between the lower posterior margin of the rib cage and the horizontal gluteal fold) that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months (Items 1 \& 2 from the Research Standards for Chronic Low-Back Pain (RScLBP) assessment).…
Interventions
- DrugDronabinol
Eligible subjects will be randomized (2:1) to dronabinol or placebo, administered orally. The dose of dronabinol will be titrated such that on Day 1, subjects will take 2.5 mg, twice. On subsequent days patients may gradually increase the total number of doses, by one dose each day, as needed and tolerated until either the optimal dose is achieved, or the dose reaches 30 mg THC per day.
- DrugPlacebo
Matching placebo will be prepared and administered in the same manner as the active medication. Titration will occur in a masked fashion such that individuals assigned to placebo undergo a similar perceived titration process.
Location
- Michael E Debakey VA Medical CenterHouston, Texas