Reducing Pain and Opioid Use With CBD

Opioid Use Disorder Clinical Trial

Official title:

Reducing Pain and Opioid Use With CBD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05299944
• Other study ID #: 21-5122
• Status: Recruiting
• Phase: Phase 2
• Start date: March 8, 2022
• Est. completion date: February 28, 2027

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: Raeghan Mueller
• Phone: 302.724.2208
• Email: raeghan.mueller[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 28, 2027
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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.
• Placebo
Placebo arm

Locations

Country	Name	City	State
United States	University of Colorado - Anschutz Medical Campus	Aurora	Colorado
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in opioid use	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
Primary	Reduction in anxiety	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
Primary	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.	0-12 Weeks
Primary	Reduction in sleep disturbance / fatigue	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	Change in opioid craving	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
Secondary	Change in inflammation	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
Secondary	Change in Anandamide (AEA)	Differences in AEA will be assessed over time as a moderating factor.	0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Secondary	Change in quality of life	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
Secondary	Change in self-reported cognitive function	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