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Safety and Efficacy of Oral Cannabis in Chronic Spine Pain

NCT05052541 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2026-01-23

No results posted yet for this study

Summary

The overall objectives of this study are to investigate the efficacy of extended cannabis treatment to reduce patient exposure to prescription opioids through its use 1) as a non-opioid analgesic treatment, and 2) as a therapy for reducing high-dose opioid use in patients with chronic spine pain.

Conditions

Interventions

DRUG

THC/CBD

Oral solution containing 5mg THC and 50 mg CBD per 1 ml

DRUG

THC

Oral solution containing 5mg THC per 1 ml

DRUG

Placebo

Oral solution containing no active drug

Sponsors & Collaborators

  • Institute of Cannabis Research

    collaborator UNKNOWN

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Emily Lindley, PhD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05052541 on ClinicalTrials.gov