BridgeMD
New treatment option for Low Back Pain
Official title Dronabinol as an Adjunct for Reducing Pain
ClinicalTrials.gov ID: NCT06454669
What this study is testing
What is Dronabinol?
Dronabinol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for low back pain.
Also referred to as Marinol, delta-9-tetrahydrocannabinol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64. Healthy volunteers may be eligible.
You may be able to join if
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability to take oral medication per protocol.
- Male or female, aged 18-64 years.
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability to take oral medication per protocol.
- Male or female, aged 18-64 years.
- 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...
- 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...
- oral contraceptives,
- contraceptive sponge,
- patch,
- double barrier (diaphragm/spermicidal or condom/spermicidal),
- intrauterine contraceptive system,
- etonogestrel implant,
- medroxyprogesterone acetate contraceptive injection,
- complete abstinence from sexual intercourse, and/or hormonal vaginal contraceptive ring.
- 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...
- Surgical sterilization (vasectomy)
- 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...
- 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)
- The participant's female partner has undergone tubal ligation (female sterilization) or is postmenopausal (one year)
- The participant's female partner has undergone placement of an intrauterine device or intrauterine system.
- True abstinence: when this is in line with the preferred and usual lifestyle of the participant.
- Agreement to adhere to Lifestyle Considerations throughout study duration.
- 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...
- 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...
- Treatment with another investigational drug or other intervention within 3 months of the screening visit.
- Pregnancy, plans to become pregnant, or lactation.
- Any treatment 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.
- Implanted spinal cord or dorsal root ganglion stimulator for pain treatment.
- 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.
- Have a history of substance abuse or dependence.
- 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...
- Have a history of seizures.
- Have uncontrolled renal, hepatic, or other systemic disorders that in the opinion of the investigator may jeopardize the patient.
- Have a history of cardiac disorders.
- Myocardial infarction or stroke in the previous 6 months.
- Resting heart rate of \> 120.
- Systolic blood pressure \> 140 mm Hg, or diastolic blood pressure \> 90 mm Hg.
- Any uncontrolled communicable disease (e.g., human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), tuberculosis, coronavirus disease (COVID), etc.).
- 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.
- Have a history of head trauma, epilepsy, or a cognitive disorder (Alzheimer's Disease, dementia).
- Have an electrocardiogram (ECG) abnormalities at screening including but not limited to bradycardia (\ 450 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.