Cannabidiol in Opioid Use Disorder and Chronic Pain
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
400mg Cannabidiol
800mg Cannabidiol
1200mg Cannabidiol
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Males and females, Veterans and non-Veterans, aged between 18 and 70 years old.
- Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment.
- Having chronic pain, uniformly operationalized as grade II (high-intensity) non-cancer musculoskeletal pain for ≥ 6 months 49
- Capable of providing informed consent in English.
- Compliant in opioid maintenance treatment and on a stable dose for two weeks or longer.
- Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco use disorder within the last 12 months.
- No current medical problems deemed contraindicated for participation by principal investigator.
- For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods.
Exclusion Criteria:
- Other current major psychiatric disorders deemed clinically unstable by the principal investigator, such as severe depression and/or active suicidal ideation.
- Having experienced major psychosocial stressors recently (≤ 6 weeks before enrollment), at the discretion of the principal investigator.
- Having received inpatient psychiatric treatment recently (≤ 60 days before enrollment).
- A study physician will determine if participants receiving products containing THC or CBD products may participate in the study.
- Current use benzodiazepines or platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor).
- Current weight of less of 60 kg.
Sites / Locations
- Department of Veterans Affairs HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
CBD 400mg
CBD 800mg
CBD 1200mg
Saline
Arm Description
CBD 400 mg
CBD 800mg
CBD 1200mg
saline
Outcomes
Primary Outcome Measures
Systematic Assessment for Treatment Emergent Events (SAFTEE)
The safety and tolerability of CBD will be assessed using the SAFTEE
Quantitative Sensory Testing (QST)
Pain will be measured by a comprehensive QST battery
Secondary Outcome Measures
Full Information
NCT ID
NCT04587791
First Posted
October 2, 2020
Last Updated
March 24, 2023
Sponsor
Yale University
Collaborators
VA Connecticut Healthcare System, National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04587791
Brief Title
Cannabidiol in Opioid Use Disorder and Chronic Pain
Official Title
Cannabidiol Pharmacotherapy for Co-occurring Opioid Use Disorder and Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
VA Connecticut Healthcare System, National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a double-blind, randomized, placebo-controlled cross-over human laboratory study with a duration of approximately 3 weeks, during which participants will come to the testing site for a total of five times: one initial screening session, and four experimental sessions where study medication, Cannabidiol (CBD) will be administered, separated by at least 72 hours to limit carryover effects.
Detailed Description
Twenty two male and female (ages 18-70) participants with comorbid opioid use disorder (OUD) and non-cancer chronic pain for at least 6 months, currently receiving methadone or buprenorphine, will be enrolled. Prior to their daily methadone or buprenorphine dose and thus at trough plasma levels of opioid, participants will receive oral CBD (400 mg, 800 mg, 1200 mg) or placebo. Subsequently, all participants will undergo laboratory testing of opioid-related outcomes.
Pain sensitivity will be measures including the well-validated Cold Pressor Test (CPT), Quantitative Sensory Testing (QST), the Short-Form McGill Pain Questionnaire (SF-MPQ) and a pain Visual Analog Scale (VAS). Attentional bias and cue-induced opioid craving will be measured using a visual probe task and the Heroin Craving Scale (HCQ-14). Negative affect will be measured using the Positive and Negative Affect Schedule (PANAS). Cognitive performance will be measured by a comprehensive cognitive battery that includes the Continuous Performance Test (CPT) and the Hopkins Verbal Learning Test (HVLT). The order of study medication administration will be counterbalanced order to minimize carryover effects. On the initial screening day and at the end of medication treatment, blood will be drawn to determine serum drug levels. Participants will be thoroughly evaluated by a physician prior to discharge on each experimental session. One week after the last study medication dose, participants will be conducted by phone for a follow-up session.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
participants will receive CBD (400 mg, 800 mg, 1200 mg) or placebo.
Masking
ParticipantInvestigator
Masking Description
participants will receive CBD (400 mg, 800 mg, 1200 mg) or placebo.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBD 400mg
Arm Type
Active Comparator
Arm Description
CBD 400 mg
Arm Title
CBD 800mg
Arm Type
Active Comparator
Arm Description
CBD 800mg
Arm Title
CBD 1200mg
Arm Type
Active Comparator
Arm Description
CBD 1200mg
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
saline
Intervention Type
Drug
Intervention Name(s)
400mg Cannabidiol
Other Intervention Name(s)
CBD
Intervention Description
Participants will receive 400mg
Intervention Type
Drug
Intervention Name(s)
800mg Cannabidiol
Other Intervention Name(s)
CBD
Intervention Description
Participants will receive 800mg
Intervention Type
Drug
Intervention Name(s)
1200mg Cannabidiol
Other Intervention Name(s)
CBD
Intervention Description
Participants will receive 1200mg
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
placebo
Intervention Description
Participants will receive saline
Primary Outcome Measure Information:
Title
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Description
The safety and tolerability of CBD will be assessed using the SAFTEE
Time Frame
up to 4 weeks
Title
Quantitative Sensory Testing (QST)
Description
Pain will be measured by a comprehensive QST battery
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females, Veterans and non-Veterans, aged between 18 and 70 years old.
Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment.
Having chronic pain, uniformly operationalized as grade II (high-intensity) non-cancer musculoskeletal pain for ≥ 6 months 49
Capable of providing informed consent in English.
Compliant in opioid maintenance treatment and on a stable dose for two weeks or longer.
Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco use disorder within the last 12 months.
No current medical problems deemed contraindicated for participation by principal investigator.
For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods.
Exclusion Criteria:
Other current major psychiatric disorders deemed clinically unstable by the principal investigator, such as severe depression and/or active suicidal ideation.
Having experienced major psychosocial stressors recently (≤ 6 weeks before enrollment), at the discretion of the principal investigator.
Having received inpatient psychiatric treatment recently (≤ 60 days before enrollment).
A study physician will determine if participants receiving products containing THC or CBD products may participate in the study.
Current use benzodiazepines or platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor).
Current weight of less of 60 kg.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joao De Aquino, M.D.
Phone
203-5711
Ext
2916
Email
joao.dequino@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Mitchell, R.N.
Phone
203-932-5711
Ext
3012
Email
ellen.mitchell@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joao De Aquino, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Veterans Affairs Hospital
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joao De'Aquino, M.D.
Phone
203-932-5711
Ext
3012
Email
joao.dequino@yale.edu
First Name & Middle Initial & Last Name & Degree
Joao De Aquino, M.D.
12. IPD Sharing Statement
Learn more about this trial
Cannabidiol in Opioid Use Disorder and Chronic Pain
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