Last updated: March 21, 2024
Sponsor: Albert Einstein College of Medicine
Overall Status: Completed
Phase
N/A
Condition
Pain
Chronic Pain
Substance Abuse
Treatment
N/AClinical Study ID
NCT04308148
2019-10029
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- At least 18 years of age
- English or Spanish fluency
- Actively certified for medical cannabis
- Intends to have a soft-gel capsule product dispensed at Vireo
- Medical cannabis qualifying conditions or complications of "chronic or severe pain" or "pain that degrades health and functional capability as an alternative to opioid useor substance use disorder"
- Joint or neuropathic pain
- Current severe pain
- Dispensed opioid analgesics within the last 60 days To maintain the integrity of the study, we do not disclose all inclusion criteria topotential participants.
Exclusion
Exclusion Criteria:
- Inability to provide informed consent
- Inability to complete study visits over 14 weeks
- Terminal illness
- Current or prior psychotic disorder
- Buprenorphine or methadone treatment for opioid use disorder within the past year
- Allergies to tapioca or coconut
- Currently pregnant, planning to become pregnant within the next 3 months, orbreastfeeding
- Condition that is considered by a pharmacist or medical provider to be acontraindication to medical cannabis use (e.g. unstable cardiac arrhythmia or specificdrug-use interaction)
Study Design
Total Participants: 217
Study Start date:
October 06, 2020
Estimated Completion Date:
March 13, 2024
Study Description
Connect with a study center
Montefiore Health System
Bronx, New York 10451
United StatesSite Not Available

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