Dronabinol as an Adjunct for Reducing Pain

Part of paid clinical trials in Houston, Texas.

Sponsor
Christopher D. Verrico
Study ID
NCT06454669
Phase
PHASE2
Status
Recruiting
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Conditions

  • Back Injuries
  • Chronic Pain
  • Low Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Dronabinol — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 15, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Drug: Dronabinol
    Dronabinol capsules, over-encapsulated with filler to match the appearance of the placebo capsule, up to 15 mg, twice per day for 8 weeks.
  • Placebo Comparator: Placebo
    Capsules with placebo (i.e., cellulose filler), twice per day for 8 weeks.

Primary Outcome Measure

Pain Intensity [ Time Frame: Baseline to 8-weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Michael E Debakey VA Medical CenterHoustonTexas77030
Christopher D Verrico, PhD
[email protected]
713-791-1414
Adetola Vaughan, MA
[email protected]
713-791-1414

Find similar trials in Houston, TX

By research site
Michael E Debakey VA Medical Center· Houston, TX

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