A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Explore the Safety and Therapeutic Potential of Dronabinol as an Adjunct for Reducing Pain
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.
• 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 in the past 6 months (Items 1 \& 2 from the Research Standards for Chronic Low-Back Pain (RScLBP) assessment).
• 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):
‣ 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 administration of the study drug. One of the following acceptable methods of contraception must be utilized:
‣ 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 male participant)
⁃ 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 pain treatment (pharmacological or otherwise) for ≥3 months at the time of the screening.