NCT06454669 Dronabinol as an Adjunct for Reducing Pain

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 75 participants in total. It began in 2024-06-15 with a primary completion date of 2028-12-31.

Brief 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.

Eligibility Criteria

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). 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, 3. patch, 4. double barrier (diaphragm/spermicidal or condom/spermicidal), 5. intrauterine contraceptive system, 6. etonogestrel implant, 7. medroxyprogesterone acetate contraceptive injection, 8. complete abstinence from sexual intercourse, and/or hormonal vaginal contraceptive ring. 7. Agree (if male) to use acceptable methods of contraception if the male participant's partner could become pregnant from the time of the first administration of the study drug until 30 days following the final administration of the study drug. One of the following acceptable methods of contraception must be utilized: 1. Surgical sterilization (vasectomy) 2. The participant's female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or sub dermal implants (commenced at least 14 days prior to study drug administration to the male participant) 3. The participant's female partner uses a medically prescribed topically applied transdermal contraceptive patch (commenced at least 14 days prior to study drug administration to the male participant) 4. The participant's female partner has undergone tubal ligation (female sterilization) or is postmenopausal (one year) 5. The participant's female partner has undergone placement of an intrauterine device or intrauterine system. 6. True abstinence: when this is in line with the preferred and usual lifestyle of the participant. 8. Agreement to adhere to Lifestyle Considerations throughout study duration. 9. On a stable opioid treatment regimen, with or without other pharmacologic or nonpharmacologic pain treatments, for ≥3 months at the time of the screening and agree to refrain from adding new analgesic medications or increasing their current dose of analgesic medications for the duration of the study. Exclusion Criteria: 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. 9. Pregnancy, plans to become pregnant, or lactation. 10. Any interventional pain procedures within 6 weeks prior to screening or at any point during study enrollment. 11. Surgical intervention or introduction/increased dose of an opioid or analgesic regimen at any point during study enrollment. 12. Implanted spinal cord or dorsal root ganglion stimulator for pain treatment. 13. Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for a current major psychiatric illness, such as bipolar disorder, major depression, or psychosis. 14. Have a history of substance abuse or dependence. 15. Have a history or current suicidality. Have an increased risk of suicide that necessitates inpatient treatment or warrants therapy excluded by the protocol, and/or current suicidal plan, per investigator clinical judgement, based on interview and defined on the Columbia Suicidality Severity Rating Scale (C-SSRS). 16. Have a history of seizures. 17. Have uncontrolled renal, hepatic, or other systemic disorders that in the opinion of the investigator may jeopardize the patient. 18. Have a history of cardiac disorders. 19. Myocardial infarction or stroke in the previous 6 months. 20. Resting heart rate of \> 120. 21. Systolic blood pressure \> 140 mm Hg, or diastolic blood pressure \> 90 mm Hg. 22. Any uncontrolled communicable disease (e.g., human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), tuberculosis, coronavirus disease (COVID), etc.). 23. Have any other illness, condition, or use of medications, which in the opinion of the P.I. and/or the admitting clinician would preclude the safe and/or successful completion of the study. 24. Have a history of head trauma, epilepsy, or a cognitive disorder (Alzheimer's Disease, dementia). 25. Have an electrocardiogram (ECG) abnormalities at screening including but not limited to bradycardia (\<55 beats per minute); prolonged heart-rate corrected QT interval (QTc) interval (\>450 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block; pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic).

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