Reducing Pain and Opioid Use With CBD

February 14, 2024 updated by: University of Colorado, Denver
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To better understand the effects of hemp-derived CBD with and without a small amount of THC, the investigators propose a Phase II randomized clinical trial (RCT) to examine the safety, tolerability, and clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of opioid users.

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.

Study visits will take place both in-person and via Zoom/online. Study participants will attend four in-person visits at the University of Colorado Anschutz at Week 0 (Baseline Medical Director Screen and Medication Dispense), Week 6, and Week 12. Research staff will meet with participants over Zoom during their Week 1 visit and will be contacted weekly during the 12-week study period. Following the Week 1 Zoom visit, participants will have the option to receive the survey link via email for Weeks 2-5 and 7-11 in lieu of meeting with a research team member over Zoom to allow more flexibility in time to complete the study surveys (participants can complete surveys at their convenience within a 3-business day period). In Week 16, approximately 4 weeks after the end of dosing, a final follow-up Zoom interview will occur.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado - Anschutz Medical Campus
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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;
  2. 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);
  3. Actively seeking or in treatment for or history of any substance use disorder, other than opioid use disorder;
  4. Currently being treated for or diagnosed with a moderate, severe, or unstable medical illness (e.g., renal disease, liver disease, cardiovascular disease). If the person has had a recent operation, they must be cleared for study participation by their surgeon or primary care doctor. Study inclusion/exclusion will be evaluated by our medical director when there are questions about applying criteria;

  5. Currently taking any of the following medications:

    1. Those known to have a major interaction with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide)
    2. Acute treatment with any antiepileptic medications (e.g. clobazam, sodium valproate)
  6. Report being treated for bipolar disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder in the last year.
  7. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
  8. Endorsing item 2 on the C-SSRS measure of suicide risk.
  9. Currently using CBD for medical reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Full-spectrum Cannabidiol
210mg/day of full-spectrum cannabidiol, containing less than 0.3%THC.
Drug: Cannabidiol
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.
Other Names:
  • CBD
Placebo Comparator: Hemp Seed Oil Placebo
210mg/day of hemp-seed oil with no cannabinoids present.
Drug: Placebo
Placebo arm
Active Comparator: Broad-spectrum Cannabidiol
210mg/day of broad-spectrum cannabidiol, containing 0%THC.
Drug: Cannabidiol
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.
Other Names:
  • CBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in opioid use
Time Frame: 0-12 Weeks
The Time Line Follow Back is a calendar-assisted measure that can be used to assess opioid use. The investigators will use this measure to create the opioid use variable.
0-12 Weeks
Reduction in anxiety
Time Frame: 0-12 Weeks
The Depression Anxiety Stress Scale measures the severity of anxiety symptoms. Possible scores range from 0 to 41 with higher scores indicating a worse outcome/more severe symptoms of anxiety.
0-12 Weeks
Reduction in pain
Time Frame: 0-12 Weeks
-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.
0-12 Weeks
Reduction in sleep disturbance / fatigue
Time Frame: 0-12 Weeks
  • The PROMIS Short Form v1.0 - Sleep Disturbance - 4A measure the severity of sleep disturbances. Possible scores range from 0 to 4 with lower scores indicating a worse outcome/more severe symptoms of sleep disturbance/fatigue.
  • The PROMIS Short Form v1.0 - Fatigue - 4a measures subject fatigue over the past 7 days on a 4 point scale, with higher scores indicating more fatigue.
0-12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in opioid craving
Time Frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
The Opioid Craving Scale will be used to assess changes in craving over time. This scale has three questions assessed using a 10-pt likert scale. Higher scores (0-30) indicate greater opioid craving.
0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in inflammation
Time Frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Differences in inflammatory markers (e.g. IL-6) will be assessed over time as a moderating factor.
0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in Anandamide (AEA)
Time Frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Differences in AEA will be assessed over time as a moderating factor.
0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in quality of life
Time Frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Changes in subjective quality of life will be assessed using the PROMIS Global-10 Short Form). Scores range from 10-50, with higher scores indicating poorer quality of life.
0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in self-reported cognitive function
Time Frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Changes in self-reported cognitive function will be assessed using the FACT-Cog. There are 37 questions on a 5-pt likert scale with higher scores indicating poorer cognition.
0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2022

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

February 22, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-5122

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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