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NCT06454669 · ClinicalTrials.gov registry record · Phase 2

Dronabinol as an Adjunct for Reducing Pain

A Phase 2 study of Chronic Pain and Low Back Pain, sponsored by Christopher D. Verri.

Recruiting
Registry status
Phase 2
Development phase
75
Enrollment target
1
Study location

NCT06454669 is a Phase 2 study of Chronic Pain and Low Back Pain that is actively recruiting participants, run by Christopher D. Verri. The registered enrollment target is 75 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06454669, a Phase 2 study of Chronic Pain and Low Back Pain, is actively recruiting participants, sponsored by Christopher D. Verri.

RECRUITING
Registry status
Phase 2
Development phase
75 participants
Enrollment target
1
Study location

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.

Interventions

  • DRUG Placebo
  • DRUG Dronabinol

Study Locations (1)

Texas

  • Michael E Debakey VA Medical Center - Houston

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2024-06-15
Est. Completion 2029-12-31
Phase Phase 2

Sponsor

Christopher D. Verri

1 total trials

What the Registry Record Tells You About NCT06454669

The ClinicalTrials.gov registry entry for NCT06454669 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (90% lower). The listed sponsor is Christopher D. Verri, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Chronic Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06454669 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT06454669 about?

NCT06454669 is a clinical study titled "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 7...

What is the current status of trial NCT06454669?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2024-06-15. Estimated completion is 2029-12-31.

What conditions does trial NCT06454669 study?

This clinical trial studies the following conditions: Chronic Pain, Low Back Pain, Back Injuries.

What interventions are being tested in trial NCT06454669?

The interventions under investigation include: Placebo (DRUG), Dronabinol (DRUG).

Who is sponsoring clinical trial NCT06454669?

This trial is sponsored by Christopher D. Verri, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06454669 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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