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 = 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
87
Patients in this group can choose what type, how much, and when to use medical marijuana to use.
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.
Maine Medical Center
Portland, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Cambridge Health Alliance
Cambridge, Massachusetts, United States
Mean Difference in Prescription Monitoring Program verified opioid dose at baseline and week 24
Median opioid dose verified by the Prescription Monitoring Program, in morphine milligram equivalents (MME) per day, over monthly interval preceding study visit.
Time frame: Week 24
Mean Difference in Pain, Enjoyment, General Activity (PEG) Scale Summed Score over post-baseline to week 24 interval
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.
Time frame: Every post-baseline day until week 24
Mean Difference in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form Summed Score at weeks 4, 8, 12, 16, 20, 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.
Time frame: 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
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.
Time frame: 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
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.
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Time frame: 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
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.
Time frame: Week 4, week 8, week 12, week 16, week 20, week 24
Mean Difference in Cannabis Use Disorder Symptoms at weeks 12 and 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.
Time frame: Week 12, Week 24
Mean Difference in Self-Reported Opioid Dose over post-baseline to week 24 interval
Self-reported opioid dose in morphine milligram equivalents (MME) per day.
Time frame: Every post-baseline day until week 24