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Brief Title: Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain
Official Title: Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain
Study ID: NCT04827992
Brief 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 = 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Maine Medical Center, Portland, Maine, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Cambridge Health Alliance, Cambridge, Massachusetts, United States