Reducing Pain and Opioid Use With CBD

NCT05299944 | Completed Phase 2 FDA Drug

• 1 other identifier: 21-5122
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

Brief Summary

This is a double-blind, placebo-controlled, parallel group study designed to assess the tolerability and efficacy of fsCBD and bsCBD, compared to a placebo control, to reduce opioid use, anxiety, and pain and improve sleep and cognitive function. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

Conditions

Opioid Use Disorder

Keywords

Opioids; Pain; Cannabidiol; CBD; Cannabis

Outcome Measures

Primary Outcomes (3)

• Reduction in pain medication use

  The Time Line Follow Back is a calendar-assisted measure that can be used to assess pain medication use. The investigators will use this measure to create the pain medication use variable. For opioids users, changes in opioid use will be assessed. For non-opioid users, non-opioid pain medication will be assessed.

  0-12 Weeks

• Reduction in THC use

  The Timeline Follow-back will be used to quantify and frequency of THC use.

  0-12 Weeks

• Reduction in pain

  -The PROMIS Numeric Rating Scale v1.0 - Pain Intensity - 1a will be used to measure pain intensity with a one question item over the past 7 days. Higher scores indicate more pain. The PROMIS Short Form v1.1 - Pain Interference - 6b rates pain on a scale from 1 (not at all) to 5 (very much), as it refers to the degree to which pain limits or interferes with subjects' physical, mental, and social activities. Higher scores indicate greater pain interference.

  0-12 Weeks

Secondary Outcomes (7)

• Change in opioid craving

  0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks

• Change in inflammation

  0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks

• Change in Anandamide (AEA)

  0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks

• Change in quality of life

  0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks

• Change in self-reported cognitive function

  0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks

Study Arms (3)

Full-spectrum Cannabidiol

ACTIVE COMPARATOR

210mg/day of full-spectrum cannabidiol, containing less than 0.3%THC.

Drug: Cannabidiol

Broad-spectrum Cannabidiol

ACTIVE COMPARATOR

210mg/day of broad-spectrum cannabidiol, containing 0%THC.

Drug: Cannabidiol

Hemp Seed Oil Placebo

PLACEBO COMPARATOR

210mg/day of hemp-seed oil with no cannabinoids present.

Drug: Placebo

Interventions

Cannabidiol DRUG

The current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in opioid consumption, opioid craving, pain, peripheral markers of inflammation, and anxiety, as well as changes in sleep, AEA, and cognition.

Also known as: CBD

Broad-spectrum Cannabidiol; Full-spectrum Cannabidiol

Placebo DRUG

Placebo arm

Hemp Seed Oil Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported desire or intent to use cannabidiol to reduce pain and/or opioid use
• Must be 18 years of age or older.

You may not qualify if:

• Self-reported recreational drug use (other than opioids) in the past 30 days or failed urine screen for cocaine, benzodiazepines (if not prescribed), MDMA, sedatives, or methamphetamine;
• Self-reported current moderate/severe alcohol use, or severe opioid use disorder on the DSM V (unless patient is medically stable and approved by personal physician as well as the Medical Director for the study);
• Actively seeking or in treatment for or history of any substance use disorder, other than opioid use disorder;
• Currently taking any of the following medications:
• Those known to have a major interaction with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide)
• Acute treatment with any antiepileptic medications (e.g. clobazam, sodium valproate)
• Report being treated for bipolar disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder in the last year.
• Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
• Endorsing item 2 on the C-SSRS measure of suicide risk.
• Currently using CBD for medical reasons.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Pain; Marijuana Abuse

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 29, 2022
• Study Start: March 8, 2022
• Primary Completion: July 29, 2025
• Study Completion: August 19, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (2)