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Dronabinol as an Adjunct for Reducing Pain

NCT06454669 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Christopher D. Verrico

    lead OTHER

Principal Investigators

  • Christopher D Verrico, phD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06454669 on ClinicalTrials.gov