Status:
COMPLETED
Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients With Chronic Non-Cancer Pain
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Cambridge Health Alliance
MaineHealth
Conditions:
Opioid Use
Pain
Eligibility:
All Genders
18-75 years
Phase:
NA
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 opio...
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...
Eligibility Criteria
Inclusion
- Men and women aged 18-75, inclusive.
- Endorsing \> 6 months of chronic, non-cancer pain.
- On stable prescription opioid doses of 25 MME or greater for \>90 days, verified by the Prescription Monitoring Program.
- Either no prior use or current light cannabis use (weekly or less in the past 12 months).
- Plans to use medical cannabis for pain to control pain and/or reduce opioid dose.
- Competent and willing to provide written informed consent in English.
- Potential participants of childbearing potential must not be pregnant at enrollment. They will be asked to self-report pregnancy status and the start date of their most recent menstrual period and agree to use effective contraception: abstinence; hormonal contraception; intra-uterine device, sterilization; or double barrier contraception, during the study.
Exclusion
- 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).
- Current cannabis use disorder; current moderate to severe substance use disorder for any substance by structured interview, EXCEPT nicotine and opioids (OUD).
- Current uncontrolled major medical illness, such as cancer, symptomatic hypothyroidism/hyperthyroidism or severe respiratory compromise.
- Use of non-prescribed opioids, by self-report.
- Dose change or initiation of medications with significant analgesic effects (e.g., tricyclic antidepressants, SSRIs, gabapentin, NSAIDs) in the past 4 weeks.
- 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.
- Actively suicidal and/or suicide attempt or psychiatric hospitalization in past year, or current suicidal ideation with specific plan or intent.
- History of intellectual disability (e.g., Down's syndrome) or other severe developmental disorder or IQ \< 70.
- 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.
- Surgery within the past month or planned during the next 6 months.
- Pregnant or trying to get pregnant or breastfeeding.
- In the opinion of the investigator or study physicians, not able to complete study procedures or safely participate in this study.
Key Trial Info
Start Date :
August 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2025
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04827992
Start Date
August 23 2021
End Date
October 31 2025
Last Update
November 5 2025
Active Locations (3)
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1
Maine Medical Center
Portland, Maine, United States, 04102
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2523
3
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139