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RECRUITING
NCT06454669
PHASE2

Dronabinol as an Adjunct for Reducing Pain

Sponsor: Christopher D. Verrico

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Explore the Safety and Therapeutic Potential of Dronabinol as an Adjunct for Reducing Pain

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2024-06-15

Completion Date

2029-12-31

Last Updated

2026-03-13

Healthy Volunteers

Yes

Interventions

DRUG

Dronabinol

Eligible subjects will be randomized (2:1) to dronabinol or placebo, administered orally. The dose of dronabinol will be titrated such that on Day 1, subjects will take 2.5 mg, twice. On subsequent days patients may gradually increase the total number of doses, by one dose each day, as needed and tolerated until either the optimal dose is achieved, or the dose reaches 30 mg THC per day.

DRUG

Placebo

Matching placebo will be prepared and administered in the same manner as the active medication. Titration will occur in a masked fashion such that individuals assigned to placebo undergo a similar perceived titration process.

Locations (1)

Michael E Debakey VA Medical Center

Houston, Texas, United States