Dronabinol as an Adjunct for Reducing Pain
Eligible age
18–64 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: Christopher D. Verrico
You may qualify if…
- ✓ 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).
- ✓ 6. For females of reproductive potential: currently practicing an effective form of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, for at least 1 month prior to screening and agrees to use such a method during study participation and for an additional 4 weeks after the end of study medication administration unless she is surgically sterile, partner is surgically sterile, or she is postmenopausal (one year):
- ✓ 1. oral contraceptives,
- ✓ 2. contraceptive sponge,
You may not qualify if…
- ✕ 1. Non-English speaking or inability to read and understand English.
- ✕ 2. Current and unwilling to stop the use of cannabis/marijuana and any other cannabinoids, including over the counter CBD products.
- ✕ 3. Reported allergic reactions to cannabis, CBD, THC, or components of the study interventions.
- ✕ 4. Have Blood Urea Nitrogen or Creatinine levels outside the normal range, or other clinically significant laboratory abnormalities.
- ✕ 5. Current use of Antiepileptic drugs.
- ✕ 6. Current use of barbiturates, benzodiazepines, ethanol, lithium, buspirone, muscle relaxants
- ✕ 7. Current use of amphetamines, other sympathomimetic agents, atropine, amoxapine, scopolamine, antihistamines, other anticholinergic agents, amitriptyline, desipramine, or other tricyclic antidepressants within 3 months of randomization.
- ✕ 8. Treatment with another investigational drug or other intervention within 3 months of the screening visit.
Where it's recruiting
Houston
Source: ClinicalTrials.gov · NCT06454669 · last updated 2026-05-18