Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Marijuana Use
- Opioid Use
- Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Care Provider)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This trial is a randomized, six-month study of medical marijuana (MM) on opioid use that will: (1) evaluate whether adults with CNCP on COT assigned to MM+POTS, compared with those assigned to WL+POTS, have greater reduction in opioid dose and/or pain severity, (2) assess whether participants assign...
This trial is a randomized, six-month study of medical marijuana (MM) on opioid use that will: (1) evaluate whether adults with CNCP on COT assigned to MM+POTS, compared with those assigned to WL+POTS, have greater reduction in opioid dose and/or pain severity, (2) assess whether participants assigned to MM+POTS, compared with those assigned to WL+POTS, have improved quality of life, improved pain interference, depression, and anxiety; and improvement in cognitive functioning, (3) evaluate whether those assigned to MM+POTS develop symptoms of CUD 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 of OUD, and neurocognitive performance. Urine collected at each visit will be assessed with quantitative assays.
Tracking Information
- NCT #
- NCT04827992
- Collaborators
- Not Provided
- Investigators
- Not Provided