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This group can begin using medical marijuana immediately and will participate in the POTS treatment groups.

This group must abstain from marijuana use and will participate in the POTS behavioral treatment alone.

Patients in this group can choose what type, how much, and when to use medical marijuana to use.

Medical Marijuana

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.

Prescription Opioid Taper Support (POTS)

Jodi Gilman, PhD

Aurora Quaye, MD

Jodi Gilman

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).

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 = 125), or to a waitlist control arm (WLC) (n = 125). 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.

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

All data, code, and materials used in the analyses can be provided by Jodi Gilman and Massachusetts General Hospital pending scientific review and a completed data use agreement/material transfer agreement beginning one year after publication of the results. Requests for all materials should be submitted to Jodi Gilman at jgilman1@mgh.harvard.edu.

Opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day. If participants decide to reduce dose at week 24, we will use the reduced dose even if the new dose cannot be immediately implemented (e.g., due to delays in refilling prescription) to ensure accurate representation of change.

The Pain, Enjoyment, General Activity (PEG) scale will assess pain intensity and interference. The scale ranges from 0-30, with a higher score indicating greater pain intensity and interference. Collected daily by a self-reported online survey.

Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form will assess changes in quality of life measures. The scale ranges from 14 - 70, with a lower score indicating greater dissatisfaction with life.

The 8-item depression subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess depression symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse depression.

The 7-item anxiety subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 will be used to assess anxiety symptoms. The scale uses a t-score metric (mean of 50, SD of 10). Higher scores indicate worse anxiety.

The DSM-5 Opioid Use Disorder Checklist will evaluate symptoms of Opioid Use Disorder (number of symptoms). The scale ranges from 0 - 11, with a higher score indicating more severe Opioid Use Disorder.

The DSM-5 Cannabis Use Disorder Checklist will evaluate symptoms of Cannabis Use Disorder (number of symptoms). The scale ranges from 0 - 11, with a higher score indicating more severe Cannabis Use Disorder.

Self-reported opioid dose in morphine milligram equivalents (MME) per day. This is collected daily by a self-reported online survey and averaged over each 4-week interval.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain	NCT04827992	Opioid Use Pain Marijuana Use	Medical Marijua... Prescription Op...	18 Years - 75 Years	Massachusetts General Hospital
Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain	NCT04827992	Opioid Use Pain Marijuana Use	Medical Marijua... Prescription Op...	18 Years - 75 Years	Massachusetts General Hospital

Spots Global Cancer Trial Database for prescription opioid taper support (pots)