Safety of Cannabidiol Given to Subject With Methadone or Buprenorphine

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05076370
Collaborator
(none)
6
Enrollment
1
Location
3
Arms
14
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overarching goal of this study is to evaluate the potential of Cannabidiol (CBD) as an adjunctive treatment for comorbid opioid use disorder (OUD) and chronic pain. This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving medication-assisted treatment (MAT) with methadone or buprenorphine.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: CBD Day 1
  • Drug: CBD Day 2
  • Drug: CBD Day 3
Early Phase 1

Detailed Description

An initial safety pilot phase will recruit six participants: three receiving treatment with methadone and three receiving treatment with buprenorphine. If the results of the pilot study support the safety of CBD administration in this clinical sample, the general study will recruit 48 participants with comorbid OUD and chronic pain, for a total of 24 completers - 12 subjects (6 men and 6 women) receiving methadone and 12 subjects (6 men and 6 women) receiving buprenorphine. Both sub-studies will enroll participants who do not currently require an inpatient hospitalization.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Initial safety pilot phase of 6 participants,(3 methadone and 3 on Buprenorphine) The general study is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving medication-assisted treatment (MAT) with methadone or buprenorphine.Initial safety pilot phase of 6 participants,(3 methadone and 3 on Buprenorphine) The general study is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving medication-assisted treatment (MAT) with methadone or buprenorphine.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Cannabidiol Pharmacotherapy for Comorbid Opioid Addiction and Chronic Pain
Actual Study Start Date :
Jun 30, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: CBD 400mg

CBD 400mg

Drug: CBD Day 1
CBD 400mg

Active Comparator: CBD 800mg

CBD 800mg

Drug: CBD Day 2
CBD 800mg

Active Comparator: CBD 1200mg

CBD 1200mg

Drug: CBD Day 3
CBD 1200mg

Outcome Measures

Primary Outcome Measures

  1. Pain Threshold [4 measurements per test day, 3 total test days]

    The Cold Pressor (CPT measures Pain threshold (in seconds). For this test, a cooler filled with cold water (32.9-34.7degrees F/0.5-1.5 degrees C) are used. Participants are instructed to immerse their hand into the water and report the first time they experience pain (pain threshold). Lower scores indicate lower pain threshold. Minimum score is 0 seconds, and a maximum cut-off score of 300 seconds is used to prevent tissue damage.

  2. Pain Tolerance [4 measurements per test day, 3 total test days]

    The Cold Pressor Test (CPT) measures pain threshold and pain tolerance (in seconds). For this test, a water cooler is filled with cold water (32.9-34.7ºF/0.5-1.5ºC) are used. To begin the CPT, Participants are then instructed to immerse their hand into the cold water bath and report when the pain becomes unbearable (pain tolerance). Lower scores indicate lower pain tolerance. Minimum score is 0 seconds, and a maximum cut-off score of 300 seconds is used to prevent tissue damage.

  3. Pain Threshold [4 measurements per test day, 3 total test days]

    The QST is a reliable, dynamic, and computerized method of quantifying distinct mechanisms of the pain experience

  4. Pain Tolerance [4 Measurements per test day, 3 total days.]

    The QST is a reliable, dynamic, and computerized method of quantifying distinct mechanisms of the pain experience

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 pain for ≥ 6 months 49.

  • Capable of providing informed consent in English.

  • Compliant in opioid maintenance treatment and on a stable dose for four 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. Acceptable contraception for females includes oral contraceptives, contraceptive depot injections, contraceptive subdermal implants, intrauterine devices, or surgical contraception methods. Acceptable contraception for males includes condoms or surgical contraception 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.

  • Methadone dose under 60mg or over 100mg

  • Buprenorphine over 24mg.

  • Having received inpatient psychiatric treatment recently (≤ 60 days before enrollment).

  • Candidates receiving products containing either THC or CBD will be excluded.

  • Current use regular use other prescription opioids, gabapentinoids (pregabalin, gabapentin), antidepressants (SSRIs, SNRIs, TCAs), benzodiazepines, platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor), or NSAIDs.

  • Current weight of less of 60 kg.

  • Allergy to sesame seed oil, which is an ingredient of the CBD formulation used.

  • Serious medical or neurological illness or treatment for a medical disorder that could interfere with study participation as determined by principal investigator.

  • Participants who have elevation of liver enzymes (ALT and/or AST) 2x above the normal limit or higher.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Veteran Affairs HospitalWest HavenConnecticutUnited States06516

Sponsors and Collaborators

  • Yale University

Investigators

  • Principal Investigator: Joao De Aquino, M.D., Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joao De Aquino, Principal Investigator, Yale University
ClinicalTrials.gov Identifier:
NCT05076370
Other Study ID Numbers:
  • 2000029286
First Posted:
Oct 13, 2021
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021