Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06544291

Combined THC and CBD for OUD and Chronic Pain

Led by Yale University · Updated on 2026-01-13

147

Participants Needed

1

Research Sites

170 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary objective of this phase 2 study is to investigate the therapeutic potential of orally administered combined delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in relieving both pain and cue-induced opioid craving in people with co-occurring opioid use disorder (OUD) and chronic pain who are undergoing methadone therapy.

CONDITIONS

Official Title

Combined THC and CBD for OUD and Chronic Pain

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form.
  • Willingness to comply with all study procedures and availability for the study duration.
  • Male or female aged 18 to 65 years.
  • Diagnosed with both opioid use disorder (meeting DSM-5 criteria) and chronic non-cancer low back pain lasting at least 3 months.
  • Prior cannabis or cannabinoid use at least once in the last 10 years.
  • Stable methadone therapy dose between 30-150 mg/day for at least 3 weeks.
  • For females of reproductive potential, use of effective contraception for at least 1 month before screening and during study participation plus 2 weeks after last dose.
  • For males of reproductive potential, use of condoms or other effective contraception methods with partner.
Not Eligible

You will not qualify if you...

  • Cannabis use disorder or other substance use disorders within the last 3 months (except opioid or tobacco use disorder).
  • Significant medical problems such as liver dysfunction (ALT/AST >1.5 times normal).
  • Neurological conditions affecting pain response or balance.
  • Untreated hypertension or other contraindications to pain stimuli.
  • Abnormal EKG findings, arrhythmia, or vasospastic disease.
  • Positive pregnancy test or lack of birth control in women of childbearing potential; refusal to use contraception in males.
  • Currently breastfeeding.
  • Planning to donate sperm (males) or ova (females) during and shortly after the study.
  • History of primary psychotic disorders or mood disorders with psychotic features.
  • Current suicidal thoughts or behavior.
  • Use of psychoactive drugs affecting pain unless on stable doses for at least 3 months.
  • Regular use of benzodiazepines, prescription opioids, or platelet inhibitors.
  • Allergies to cannabis, sesame oil/seeds, or Butylated Hydroxytoluene (BHT).
  • Difficulty swallowing capsules.
  • Recent high levels of THC in urine requiring abstinence before participation.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Connecticut Mental Health Center

New Haven, Connecticut, United States, 06519

Actively Recruiting

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Research Team

J

Julia V. Meyerovich, M.S.

CONTACT

J

Joao P. De Aquino, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

3

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