Combined THC and CBD for OUD and Chronic Pain

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06544291
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Pain
  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • CBD 300mg — DRUG
    3 Nantheia™ (100mg) softgel capsules and 3 placebo (0mg) softgel capsules will be administered to participants on one of the three test session days.
  • CBD 600mg — DRUG
    6 Nantheia™ (100mg) softgel capsules will be administered to participants on one of the three test session days.
  • Placebo 0mg — DRUG
    6 placebo (0 mg) softgel capsules will be administered to participants on one of the three test session days.

Study Details

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.

Key Dates

Start date
Oct 22, 2024
Status verified
Jan 2026
Primary completion
Jan 28, 2028
Completion
Jan 28, 2028

Study Design

Enrollment
147 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Active Comparator: Dronabinol 5mg
    Participants will be randomized to which dronabinol (or placebo) dose they receive. The fixed dose they receive will be administered across all three test sessions. Therefore, participants may receive a single capsule of 5 mg Dronabinol across all three test sessions
  • Active Comparator: Dronabinol 10mg
    Participants will be randomized to which dronabinol (or placebo) dose they receive. The fixed dose they receive will be administered across all three test sessions. Therefore, participants may receive a single capsule of 10 mg Dronabinol across all three test sessions
  • Placebo Comparator: Placebo 0mg
    Participants will be randomized to which dronabinol (or placebo) dose they receive. The fixed dose they receive will be administered across all three test sessions. Therefore, participants may receive a single capsule of 0 mg Dronabinol across all three test sessions

Primary Outcome Measure

Primary Outcome Variable #1: Pain Sensitivity [ Time Frame: Up to 8 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Connecticut Mental Health CenterNew HavenConnecticut06519
Thomas McMahon
[email protected]
203-974-5950

Find similar trials in New Haven, CT

By research site
Connecticut Mental Health Center· New Haven, CT

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