Dronabinol as an Adjunct for Reducing Pain (NCT06454669)
๐ฉบ Plain-English Summary (8th-Grade Level)
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 \[dronabinol, synthetic ฮ9-tetrahydrocannabinol (THC)\] 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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (23 items) and avoid the listed exclusions (26 items).
Location: Michael E Debakey VA Medical Center โ Houston, Texas
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Non-English speaking or inability to read and understand English.
- Current and unwilling to stop the use of cannabis/marijuana and any other cannabinoids, including over the counter CBD products.
- Reported allergic reactions to cannabis, CBD, THC, or components of the study interventions.
- Have Blood Urea Nitrogen or Creatinine levels outside the normal range, or other clinically significant laboratory abnormalities.
- Current use of Antiepileptic drugs.
- Current use of barbiturates, benzodiazepines, ethanol, lithium, buspirone, muscle relaxants
- 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.
- Treatment with another investigational drug or other intervention within 3 months of the screening visit.
- Pregnancy, plans to become pregnant, or lactation.
- Any interventional pain procedures within 6 weeks prior to screening or at any point during study enrollment.
- Surgical intervention or introduction/increased dose of an opioid or analgesic regimen at any point during study enrollment.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- Michael E Debakey VA Medical Center โ Houston, Texas
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.