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Combined THC and CBD for OUD and Chronic Pain

NCT06544291 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2026-01-13

No results posted yet for this study

Summary

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

Interventions

DRUG

CBD 300mg

3 Nantheia™ (100mg) softgel capsules and 3 placebo (0mg) softgel capsules will be administered to participants on one of the three test session days.

DRUG

CBD 600mg

6 Nantheia™ (100mg) softgel capsules will be administered to participants on one of the three test session days.

DRUG

Placebo 0mg

6 placebo (0 mg) softgel capsules will be administered to participants on one of the three test session days.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Joao P. De Aquino, M.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2028-01-28
Completion
2028-01-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06544291 on ClinicalTrials.gov