# Dronabinol as an Adjunct for Reducing Pain

> **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637)
> **Publisher:** CED Clinic (https://cedclinic.com)
> **Canonical URL:** https://cedclinic.com/dronabinol-placebo-controlled-trial-chronic-pain/
> **Published:** 2026-03-18T17:40:04-04:00 | **Last Modified / Clinically Audited:** 2026-09-28T15:54:04-04:00
> **Clinical Summary:** Explore the dronabinol placebo-controlled trial assessing safety and feasibility for chronic low back pain treatment in this clinical study.

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CED Clinical Relevance  #97High Clinical Relevance  Strong evidence or policy relevance with direct clinical implications.
Clinical Trial Watch  |  CED Clinic
Clinical Trial[Chronic Pain](https://cedclinic.com/cannabinoids-pain-management-opioid-alternative/)Low Back PainDronabinolPlacebo-Controlled

Trial ID
NCT06454669

Phase
N/A

Status
Recruiting

Condition
Low Back Pain

Intervention
Dronabinol

Why This Matters

Chronic low back pain affects millions globally with limited effective treatment options, and this represents one of the first rigorous placebo-controlled trials specifically examining synthetic THC for this indication. The study addresses a critical evidence gap in [cannabinoid medicine](https://cedclinic.com/cannabinoids-prostate-cancer-anti-tumor-drugs/) where most [chronic pain](https://cedclinic.com/cannabinoids-pain-management-opioid-alternative/) data comes from observational studies rather than controlled trials.

Clinical Summary

This is an exploratory proof-of-concept, double-blind, placebo-controlled trial randomizing up to 75 participants with chronic low back pain 2:1 to receive oral dronabinol (synthetic THC) up to 30mg daily versus placebo over 8 weeks. The primary focus is establishing safety profiles and feasibility rather than efficacy endpoints, with results intended to inform the design of future larger-scale trials. The study is currently recruiting participants at a single site.

Dr. Caplan’s Take

“If this trial demonstrates acceptable safety and tolerability profiles, it could provide the foundational data needed to advance synthetic THC into larger efficacy trials for chronic low back pain. This represents an important step toward evidence-based cannabinoid prescribing for one of the most common pain conditions I encounter in practice.”

Clinical Perspective
Patients should understand this is an early-stage safety study, not designed to definitively prove effectiveness for pain relief. Clinicians interested in cannabinoid [pain management](https://cedclinic.com/cbd-cbg-topicals-for-eczema/) should monitor these results closely, as they may inform future [prescribing guidelines](https://cedclinic.com/private-uk-cannabis-clinics-regulation-patient-safety/) and help establish dosing frameworks for dronabinol in chronic pain conditions.

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📰 Source: [https://clinicaltrials.gov/study/NCT06454669](https://clinicaltrials.gov/study/NCT06454669)

Table of Contents

- [FAQ](#FAQ)[What is dronabinol, and how is it being tested in this trial?](#What_is_dronabinol_and_how_is_it_being_tested_in_this_trial)
- [How many people will be enrolled, and how are they assigned?](#How_many_people_will_be_enrolled_and_how_are_they_assigned)
- [Is this trial designed to prove that dronabinol relieves back pain?](#Is_this_trial_designed_to_prove_that_dronabinol_relieves_back_pain)
- [Is the dronabinol back pain trial currently enrolling participants?](#Is_the_dronabinol_back_pain_trial_currently_enrolling_participants)
- [Related](#Related)

## FAQ

### What is dronabinol, and how is it being tested in this trial?

Dronabinol is synthetic THC. In this trial, people with chronic low back pain take oral dronabinol at doses up to 30 mg daily, or a placebo, over 8 weeks, and the two groups are compared.

### How many people will be enrolled, and how are they assigned?

The trial plans to randomize up to 75 participants with chronic low back pain in a 2:1 ratio, so about two participants receive dronabinol for every one who receives placebo. It is an exploratory proof-of-concept study with a double-blind, placebo-controlled design.

### Is this trial designed to prove that dronabinol relieves back pain?

No. Its primary focus is establishing safety profiles and feasibility rather than efficacy endpoints. The results are intended to inform the design of future, larger trials, so this study is not built to show definitively whether dronabinol reduces low back pain.

### Is the dronabinol back pain trial currently enrolling participants?

Yes. The trial, registered as NCT06454669, is listed as recruiting, with participants being enrolled at a single site. The summary does not describe eligibility criteria beyond chronic low back pain, and it does not name the site location.

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Understand the clinical implications of real-world evidence in [cannabinoid research](https://cedclinic.com/cannabinoids-in-reward-processing-pain-perception/), relevant to dronabinol and [pain management](https://cedclinic.com/cbd-cbg-topicals-for-eczema/).

[Learn about real-world evidence](https://cedclinic.com/clinical-implications-real-world-evidence-cannabis-care/)

 

### Related

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### Verification & Medical Governance

- **Lead Clinical Author:** Benjamin Caplan, MD
- **Credentials:** Board Certified in Family Medicine (ABFM), Former CMO Canna Care Docs (250,000+ patients supervised), Founder & CMO CED Clinic & CED Foundation, Author of *The Doctor-Approved Cannabis Handbook* (Penguin Random House).
- **Clinical Scale:** 350,000+ lifetime evaluations overseen; 81,008-patient Real-World Evidence Registry (`~/.ced_rwe_vault.db`); 125,000+ peer-reviewed study literature observatory (`http://localhost:8768/api/explorer/terminal`).
- **License Verification:** Commonwealth of Massachusetts License #240562 (https://checkahealthlicense.mass.gov/).
- **NPI Registry:** 1962722637 (https://npiregistry.cms.hhs.gov/provider-view/1962722637).
- **Ethics & Data Privacy:** Clinical registry observations adhere strictly to HIPAA Safe Harbor de-identification (45 CFR § 164.514(b)) and criteria for secondary research exemption under 45 CFR § 46.104(d)(4).
