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Reducing Pain and Opioid Use With CBD

Primary Purpose

Opioid Use Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol
Placebo
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring Opioids, Pain, Cannabidiol, CBD, Cannabis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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.

Sites / Locations

  • University of Colorado DenverRecruiting
  • University of Colorado DenverRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Full-spectrum Cannabidiol

Broad-spectrum Cannabidiol

Hemp Seed Oil Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change 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.
Change in sleep disturbance
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.
Change in 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.
Change 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.
Change in pain intensity
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.
Change in pain interference
The PROMIS Short Form v1.1 - Pain Interference - 6b scale will be used to assess how disruptive pain was over the past 7 days. There are six questions with a total score of 30-higher scores indicate more interference.
Change in pain behavior
the PROMIS Pain Behavior Scale will be used to assess changes in pain behavior on seven aspects. Each is measured on a 6 point scale with a higher score indicating more pain behavior (scale 0-42).
Change in subjective pain
The McGill Pain Questionnaire measure the severity of subjective pain. Possible scores range from 0 to 78 with higher scores indicating a worse outcome/more severe symptoms of subjective pain.

Secondary Outcome Measures

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.
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.
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.
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.
Change in inflammation
Differences in inflammatory markers (e.g. IL-6) will be assessed over time as a moderating factor.
Change in inflammation
Differences in inflammatory markers (e.g. IL-6) will be assessed over time as a moderating factor.
Change in inflammation
Differences in inflammatory markers (e.g. IL-6) will be assessed over time as a moderating factor.
Change in inflammation
Differences in inflammatory markers (e.g. IL-6) will be assessed over time as a moderating factor.
Change in Anandamide (AEA)
Differences in AEA will be assessed over time as a moderating factor.
Change in Anandamide (AEA)
Differences in AEA will be assessed over time as a moderating factor.
Change in Anandamide (AEA)
Differences in AEA will be assessed over time as a moderating factor.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 22, 2022
Last Updated
December 12, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05299944
Brief Title
Reducing Pain and Opioid Use With CBD
Official Title
Reducing Pain and Opioid Use With CBD
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
February 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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. The initial Week 0 / Baseline visit will take place at the University of Colorado Anschutz Medical Campus. There will be in-person visits at Weeks 1, 6, and 12. Participants will be contacted by Zoom each remaining week during the 12-week period. A follow up Zoom interview will occur in Week 16, approximately 4 weeks after the end of dosing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
Opioids, Pain, Cannabidiol, CBD, Cannabis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full-spectrum Cannabidiol
Arm Type
Active Comparator
Arm Description
210mg/day of full-spectrum cannabidiol, containing less than 0.3%THC.
Arm Title
Broad-spectrum Cannabidiol
Arm Type
Active Comparator
Arm Description
210mg/day of full-spectrum cannabidiol, containing 0%THC.
Arm Title
Hemp Seed Oil Placebo
Arm Type
Placebo Comparator
Arm Description
210mg/day of hemp-seed oil with no cannabinoids present.
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Other Intervention Name(s)
CBD
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo arm
Primary Outcome Measure Information:
Title
Change in opioid use
Description
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.
Time Frame
0-12 Weeks
Title
Change in sleep disturbance
Description
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.
Time Frame
0-12 Weeks
Title
Change in fatigue
Description
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.
Time Frame
0-12 Weeks
Title
Change in anxiety
Description
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.
Time Frame
0-12 Weeks
Title
Change in pain intensity
Description
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.
Time Frame
0-12 Weeks
Title
Change in pain interference
Description
The PROMIS Short Form v1.1 - Pain Interference - 6b scale will be used to assess how disruptive pain was over the past 7 days. There are six questions with a total score of 30-higher scores indicate more interference.
Time Frame
0-12 Weeks
Title
Change in pain behavior
Description
the PROMIS Pain Behavior Scale will be used to assess changes in pain behavior on seven aspects. Each is measured on a 6 point scale with a higher score indicating more pain behavior (scale 0-42).
Time Frame
0-12 Weeks
Title
Change in subjective pain
Description
The McGill Pain Questionnaire measure the severity of subjective pain. Possible scores range from 0 to 78 with higher scores indicating a worse outcome/more severe symptoms of subjective pain.
Time Frame
0-12 Weeks
Secondary Outcome Measure Information:
Title
Change in opioid craving
Description
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.
Time Frame
0-6 Weeks
Title
Change in opioid craving
Description
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.
Time Frame
6-12 Weeks
Title
Change in opioid craving
Description
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.
Time Frame
0-12 Weeks
Title
Change in opioid craving
Description
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.
Time Frame
0-16 Weeks
Title
Change in inflammation
Description
Differences in inflammatory markers (e.g. IL-6) will be assessed over time as a moderating factor.
Time Frame
0-6 Weeks
Title
Change in inflammation
Description
Differences in inflammatory markers (e.g. IL-6) will be assessed over time as a moderating factor.
Time Frame
6-12 Weeks
Title
Change in inflammation
Description
Differences in inflammatory markers (e.g. IL-6) will be assessed over time as a moderating factor.
Time Frame
0-12 Weeks
Title
Change in inflammation
Description
Differences in inflammatory markers (e.g. IL-6) will be assessed over time as a moderating factor.
Time Frame
0-16 Weeks
Title
Change in Anandamide (AEA)
Description
Differences in AEA will be assessed over time as a moderating factor.
Time Frame
0-6 Weeks
Title
Change in Anandamide (AEA)
Description
Differences in AEA will be assessed over time as a moderating factor.
Time Frame
6-12 Weeks
Title
Change in Anandamide (AEA)
Description
Differences in AEA will be assessed over time as a moderating factor.
Time Frame
0-12 Weeks
Title
Change in quality of life
Description
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.
Time Frame
0-6 Weeks
Title
Change in quality of life
Description
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.
Time Frame
6-12 Weeks
Title
Change in quality of life
Description
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.
Time Frame
0-12 Weeks
Title
Change in quality of life
Description
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.
Time Frame
0-16 Weeks
Title
Change in self-reported cognitive function
Description
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.
Time Frame
0-6 Weeks
Title
Change in self-reported cognitive function
Description
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.
Time Frame
6-12 Weeks
Title
Change in self-reported cognitive function
Description
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.
Time Frame
0-12 Weeks
Title
Change in self-reported cognitive function
Description
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.
Time Frame
0-16 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Self-reported desire or intent to use cannabidiol to reduce pain and/or opioid use Must be 18 years of age or older. Exclusion Criteria: Self-reported recreational drug use (other than opioids) in the past 30 days or failed urine screen for cocaine, benzodiazepines, 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 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raeghan Mueller
Phone
302.724.2208
Email
raeghan.mueller@cuanschutz.edu
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raeghan Mueller
Phone
303-724-2208
Email
raeghan.mueller@cuanschutz.edu
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raeghan Mueller
Email
raeghan.mueller@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Kent Hutchison, PhD

12. IPD Sharing Statement

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Reducing Pain and Opioid Use With CBD

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