Actively Recruiting
Dronabinol as an Adjunct for Reducing Pain
Led by Christopher D. Verrico · Updated on 2026-03-13
75
Participants Needed
1
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dronabinol as an Adjunct for Reducing Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided.
- Willingness to comply with all study procedures and available for the study duration.
- Ability to take oral medication as required by the study.
- Male or female aged 18 to 64 years.
- Chronic low back pain lasting at least 3 months with pain on at least half the days in the past 6 months.
- For females of reproductive potential: using two effective types of birth control with low failure rates for at least 1 month before screening and agreeing to continue during the study and 4 weeks after.
- Males agree to use acceptable contraception methods if their partner could become pregnant during the study and for 30 days after.
- Agreement to follow lifestyle considerations during the study.
- On stable pain treatment for 3 months or more at screening.
You will not qualify if you...
- Current use of cannabis, marijuana, or any cannabinoids including over-the-counter CBD products and unwillingness to stop.
- Allergic reactions to cannabis, CBD, THC, or study medication components.
- Blood Urea Nitrogen or Creatinine outside normal range or other significant lab abnormalities.
- Current use of antiepileptic drugs.
- Current use of barbiturates, benzodiazepines, ethanol, lithium, buspirone, or muscle relaxants.
- Current use of amphetamines, sympathomimetics, atropine, amoxapine, scopolamine, antihistamines, anticholinergics, amitriptyline, desipramine, or other tricyclic antidepressants within 3 months.
- Participation in another investigational drug or intervention trial within 3 months.
- Pregnancy, plans to become pregnant, or breastfeeding.
- Interventional pain procedures within 6 weeks prior to screening or during study.
- Surgical intervention or opioid dose changes during study.
- Implanted spinal cord or dorsal root ganglion stimulator.
- Current major psychiatric illness including bipolar disorder, major depression, or psychosis.
- History of substance abuse or dependence.
- History or current suicidality requiring inpatient treatment or current suicidal plan.
- History of seizures.
- Uncontrolled renal, hepatic, or systemic disorders.
- History of cardiac disorders.
- Myocardial infarction or stroke in past 6 months.
- Resting heart rate over 120 bpm.
- Blood pressure over 140/90 mm Hg.
- Uncontrolled communicable diseases (e.g., HIV, AIDS, tuberculosis, COVID).
- Any other illness or medication use that may prevent safe study completion.
- History of head trauma, epilepsy, or cognitive disorders like Alzheimer's or dementia.
- ECG abnormalities including bradycardia below 55 bpm, prolonged QTc interval over 450 msec, Wolff-Parkinson White syndrome, wide complex tachycardia, certain heart blocks, or bundle branch block.
- Severe gastrointestinal narrowing.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Michael E Debakey VA Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Christopher D Verrico, PhD
CONTACT
A
Adetola O Vaughan, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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