NCT04827992

Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will use a randomized controlled design to test whether medical marijuana use by adults on high-dose chronic opioid therapy (COT) for chronic non-cancer pain is associated with reduced opioid dose and improved pain intensity and interference when added to a 24-week behavioral intervention (POTS).

Detailed description

This trial is a randomized, six-month study of medical marijuana (MM) on opioid use that will: (1) evaluate whether adults with chronic, non-cancer pain on COT assigned to MM+POTS, compared with those assigned to WL+POTS, have greater reduction in opioid dose and/or pain intensity and interference, (2) assess whether participants assigned to MM+POTS, compared with those assigned to WL+POTS, have improved quality of life, depression, and anxiety; and reduced self-reported opioid dose, (3) evaluate whether those assigned to MM+POTS develop symptoms of CUD and have a reduced number of OUD symptoms over the 24-week intervention, as well as at the 12-month time point. Participants will be randomly assigned to either an active MM arm (n = 60), or to a waitlist control arm (WLC) (n = 60). Participants will be assessed at baseline, every 4 weeks for 6 months, and at a 12-month follow-up for opioid use, development of CUD, development or resolution of OUD, and neurocognitive performance. Urine collected will be assessed with quantitative assays.

Conditions

• Opioid Use
• Pain
• Marijuana Use

Interventions

Type	Name	Description
DRUG	Medical Marijuana	Patients in this group can choose what type, how much, and when to use medical marijuana to use.
BEHAVIORAL	Prescription Opioid Taper Support (POTS)	Prescription Opioid Taper Support (POTS), a manualized behavioral prescription opioid taper support intervention developed by consultant, will be offered weekly to all participants to support behavioral self-management of pain and structured, voluntary taper of COT dose.

Timeline

• Start date: 2021-08-23
• Primary completion: 2025-05-01
• Completion: 2025-10-31
• First posted: 2021-04-01
• Last updated: 2025-11-05

Locations

3 sites across 1 country: United States