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

November 16, 2023 updated by: Jodi Gilman, Massachusetts General Hospital
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).

Study Overview

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 = 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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Maine
      • Portland, Maine, United States, 04102
    • Massachusetts
      • Boston, Massachusetts, United States, 02114-2523
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
      • Cambridge, Massachusetts, United States, 02139
        • Active, not recruiting
        • Cambridge Health Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women aged 18-75, inclusive.
  2. Endorsing > 6 months of chronic, non-cancer pain.
  3. On stable prescription opioid doses of 25 MME or greater for >90 days, verified by the Prescription Monitoring Program.
  4. Either no prior use or current light cannabis use (weekly or less in the past 12 months).
  5. Plans to use medical cannabis for pain to control pain and/or reduce opioid dose.
  6. Competent and willing to provide written informed consent in English.
  7. Potential participants of childbearing potential must have a negative urine pregnancy test at enrollment and agree to use effective contraception: abstinence; hormonal contraception; intra-uterine device, sterilization; or double barrier contraception, during the study.

Exclusion Criteria:

  1. Current cannabis use (including inhaled or ingested CBD products) of greater than weekly on average in the past 12 months, assessed via self-report (no more than 10 times in the past 90 days).
  2. Current cannabis use disorder; current moderate to severe substance use disorder for any substance by structured interview, EXCEPT nicotine and opioids (OUD).
  3. Current uncontrolled major medical illness, such as cancer, symptomatic hypothyroidism/hyperthyroidism or severe respiratory compromise.
  4. Use of non-prescribed opioids, by self-report.
  5. Dose change or initiation of medications with significant analgesic effects (e.g., tricyclic antidepressants, SSRIs, gabapentin, NSAIDs) in the past 4 weeks.
  6. Concomitant medications will be discussed at each study visit, and any medications that may interact with cannabinoids (e.g., warfarin) will be discussed with a study clinician prior to enrollment or continued participation.
  7. Actively suicidal and/or suicide attempt or psychiatric hospitalization in past year, or current suicidal ideation with specific plan or intent.
  8. History of intellectual disability (e.g., Down's syndrome) or other severe developmental disorder or IQ < 70.
  9. Current diagnosis of delirium, dementia, amnestic, or other cognitive disorder; current diagnosis of bipolar II disorder; lifetime diagnosis of bipolar I disorder, schizophrenia spectrum, or other psychotic disorder.
  10. Surgery within the past month or planned during the next 6 months.
  11. Pregnant or trying to get pregnant or breastfeeding.
  12. In the opinion of the investigator or study physicians, not able to complete study procedures or safely participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medical Marijuana + Prescription Opioid Taper Support (POTS) behavioral treatment
This group can begin using medical marijuana immediately and will participate in the POTS treatment groups.
Patients in this group can choose what type, how much, and when to use medical marijuana to use.
Other Names:
  • Cannabis
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.
Active Comparator: Prescription Opioid Taper Support (POTS) treatment alone
This group must abstain from marijuana use and will participate in the POTS behavioral treatment alone.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Difference in Prescription Monitoring Program verified opioid dose at baseline and week 24
Time Frame: Baseline and week 24
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.
Baseline and week 24
Mean Difference in Pain, Enjoyment, General Activity (PEG) Scale Summed Score over post-baseline to week 24 interval
Time Frame: Every post-baseline day until week 24
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.
Every post-baseline day until week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form Summed Score at weeks 4, 8, 12, 16, 20, 24
Time Frame: Week 4, week 8, week 12, week 16, week 20, week 24
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.
Week 4, week 8, week 12, week 16, week 20, week 24
Mean Difference in PROMIS-29 Depression Subscale Summed Score at weeks 4, 8, 12, 16, 20, 24
Time Frame: Week 4, week 8, week 12, week 16, week 20, week 24
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.
Week 4, week 8, week 12, week 16, week 20, week 24
Mean Difference in PROMIS-29 Anxiety Subscale Summed Score at weeks 4, 8, 12, 16, 20, 24
Time Frame: Week 4, week 8, week 12, week 16, week 20, week 24
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.
Week 4, week 8, week 12, week 16, week 20, week 24
Mean Difference in Opioid Use Disorder Symptoms at weeks 4, 8, 12, 16, 20, 24
Time Frame: Week 4, week 8, week 12, week 16, week 20, week 24
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.
Week 4, week 8, week 12, week 16, week 20, week 24
Mean Difference in Cannabis Use Disorder Symptoms at weeks 4, 8, 12, 16, 20, 24
Time Frame: Week 4, week 8, week 12, week 16, week 20, week 24
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.
Week 4, week 8, week 12, week 16, week 20, week 24
Mean Difference in Self-Reported Opioid Dose at weeks 4, 8, 12, 16, 20, 24
Time Frame: Week 4, week 8, week 12, week 16, week 20, week 24
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.
Week 4, week 8, week 12, week 16, week 20, week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2021

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will become available beginning one year after publication of the results.

IPD Sharing Access Criteria

Data will be provided pending a scientific review and a completed data use agreement/material transfer agreement. Requests should be submitted to Jodi Gilman at jgilman1@mgh.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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