Dronabinol As an Adjunct for Reducing Pain (DARP)-Texas Children's Hospital (NCT06834997) | Clinical Trial Compass
WithdrawnPhase 2
Dronabinol As an Adjunct for Reducing Pain (DARP)-Texas Children's Hospital
Stopped: Due to an ongoing national shortage of dronabinol, the study is being discontinued. Given the inability to ensure consistent medication availability, continuation of the study would compromise protocol integrity and participant safety.
United States0Started 2026-04-01
Plain-language 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 e endometriosis-associated chronic pelvic pain (endo-CPP) 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 participate
Age range18 Years – 64 Years
SexFEMALE
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Inclusion 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.
✓. Female, aged 18-64 years.
✓. Females aged ≥ 18 years clinically diagnosed with endometriosis meeting one of the following criteria: a. Patients with previous surgical confirmation of endometriosis and a high suspicion of recurrence b. Patients with imaging (MRI or ultrasonography) findings highly suggestive of endometriosis and confirmed after surgery.
✓. Has chronic endometriosis pain that has persisted at least 3 months and has resulted in pain as determined by the Endometriosis Health Profile Questionnaire (EHP-30).
✓. 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): a. contraceptive sponge, b. patch, c. double barrier (diaphragm/spermicidal or condom/spermicidal), d. intrauterine contraceptive system, e etonogestrel implant, f. medroxyprogesterone acetate contraceptive injection, g. complete abstinence from sexual intercourse, and/or hormonal vaginal contraceptive ring.
✓. Patients using oral contraceptives, vaginal ring for contraception and/or management of endometriosis, can be included if both they and their primary provider agree to stopping their medication and transitioning to dronabinol (THC) as the primary treatment of endometriosis throughout the study period
Exclusion criteria
✕. Current and unwilling to stop use of cannabis/marijuana and any other cannabinoids (CBD), including over the counter CBD products.
✕. Known 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 automated external defibrillator (AED)
✕. Chronic daily opioid use and any chronic pain or frequently reoccurring pain condition, other than endometriosis, that is treated with opioids for \> 14 days per month
✕. Women with a BMI \> 35 kg/m2
✕. Current use of barbiturates, benzodiazepines, ethanol, lithium, buspirone, muscle relaxants which in the opinion of the P.I. and/or the admitting clinician would preclude the safe and/or successful completion of the study.
✕. Current use of amphetamines, other sympathomimetic agents, atropine, amoxapine, scopolamine, antihistamines, other anticholinergic agents, amitriptyline, or desipramine, within 3 months of randomization