Combined THC and CBD for OUD and Chronic Pain
NCT Number: NCT06544291
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Pain|Opioid Use Disorder
Interventions: DRUG: CBD 300mg|DRUG: CBD 600mg|DRUG: Placebo 0mg
Sponsor: Yale University
Collaborators: National Institute on Drug Abuse (NIDA)|National Institutes of Health (NIH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 147
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-10-01
Completion Date: 2028-01-28
Locations: Connecticut Mental Health Center, New Haven, Connecticut, 06519, United States

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.

Primary Outcome Measures: Primary Outcome Variable #1: Pain Sensitivity, We will measure pain sensitivity using a comprehensive QST battery at baseline and approximately hourly for 8 hours. The battery includes several nociceptive modalities such as pressure, mechanical, heat, and cold stimuli. The main outcome will be a composite pain sensitivity measure, integrating data from the QST battery., Up to 8 hours|Primary Outcome Variable #2: Opioid Craving, We will measure opioid craving using the short form Heroin Craving Questionnaire (HCQ-14) given to participants before and after a watching a visual probe task used to induce craving., Baseline and +180 minutes post dose
Secondary Outcome Measures: Secondary Outcome Variable #1a: Cognitive/psychomotor effects (CPT), The cognitive/psychomotor effects of THC and CBD will be assessed using the Continuous Performance Test (CPT). For the CPT, the primary outcome will be the throughput score, which indexes attention/working memory accuracy (i.e. percent of correct responses) and speed (i.e. reaction time)., +180 minutes post dose|Secondary Outcome Variable #1b: Cognitive/psychomotor effects (HVLT), The cognitive/psychomotor effects of THC and CBD will be assessed using the Hopkins Verbal Learning Test (HVLT). The primary outcome for the HVLT will be immediate and delayed recall, which index verbal memory., +180 minutes post dose|Secondary Outcome Variable #2a: Abuse potential of combined THC and CBD (MCP), The abuse potential of combined THC and CBD will be assessed using a modified Multiple-Choice Procedure (MCP) at the end of each test session. The primary outcome for the MCP is the crossover point (i.e., the value at which participants choose money over the study medication)., +480 post dose|Secondary Outcome Variable #2b: Abuse potential of combined THC and CBD (DEQ), The abuse potential of combined THC and CBD will be assessed using the Drug Effects Questionnaire (DEQ) administered at baseline and every 30 minutes. The primary DEQ outcome is the Stimulatory Effects subscale, obtained by averaging participants responses to the items: "Feel High"; "Feel Stimulated"; and "Feel the Drug Strength"., Up to 8 hours|Secondary Outcome Variable #3a: Monitor adverse events from the study medications (SAFTEE), To monitor adverse events from the study medications, the Systematic Assessment for Treatment Emergent Events (SAFTEE) will be administered before and after each experimental session and during the one-week follow-up. This is a symptom checklist that has been used successfully in our previous studies to assess possible side effects of study medications. It includes information regarding severity of any presenting side effects, as well as the course of action taken by study staff in response., Baseline ; +480 minutes post dose; One-week after last test session|Secondary Outcome Variable #3b: Monitor adverse events from the study medications (Cardiovascular), To monitor cardiovascular effects from the study medications, heart rate and blood pressure will be measured at baseline and every 30 minutes during the experimental sessions, and at the one-week follow-up., Up to 8 hours and One-week after last test session
Other Outcome Measures: Central Sensitization, A central sensitization score will be generated by averaging mechanical temporal summation (TSP), thermal TSP, and conditioned pain modulation (CPM), and after-sensation Z-scores. Negative values will denote antinociception, and positive values will denote pronociception (or central sensitization)., Up to 8 hours|THC and CBD plasma levels, Whole blood methadone and THC/CBD levels will be obtained to examine potential drug interactions, using liquid chromatography-tandem mass spectrometry (LC-MS/MS). We will determine the peak concentration (Cmax) and time to attain Cmax concentration (Tmax) of each analyte., Up to 8 hours|Influence of sex, We will explore if sex moderates the relationships hypothesized in the primary and secondary objectives., Up to 8 hours