Montefiore Health System
The Bronx, New York, 10451, United States
NCT Number: NCT04308148
The study will examine how medical cannabis use affects opioid analgesic use. This landmark study will be among the first to examine the effect of medical cannabis with different THC/CBD (Tetrahydrocannibinol/Cannabidiol) content on opioid use as well as adverse events.
Looking for future studies?
Notify Me18 year–99 year
All sexes
Observational
The Bronx, New York, 10451, United States
This study will examine how medical cannabis use affects opioid analgesic use, with particular attention to THC/CBD (Tetrahydrocannibinol/Cannabidiol) content and adverse events. We will enroll adults with (a) severe or chronic neuropathic or joint pain, (b) prescribed opioid analgesic use, (c) active certification for medical cannabis, and (d) intends to have soft gel capsule products dispensed at Vireo (medical cannabis dispensary) (including a high THC:low CBD product, an equal THC:CBD (Tetrahydrocannibinol:Cannabidiol) product, and a low THC:high CBD product). Over the 14 weeks, data sources will include questionnaires; medical, pharmacy, and Prescription Monitoring Program (PMP) records; and urine samples. The primary independent variable will be type of soft gel capsule product, and the primary outcome will be cumulative opioid analgesic dose.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
To maintain the integrity of the study, we do not disclose all inclusion criteria to potential participants.
Exclusion criteria
Time frame: Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.
The primary outcome will be opioid analgesic use.
Time frame: Adverse events will be over 14 weeks
(e.g. Cannabis use disorder, illicit drug use, diversion of medical cannabis, accidents and injuries)
Albert Einstein College of Medicine
Other
Does Medical Cannabis Reduce Opioid Use in Adults With Pain: An Observational Study
Acronym: ReLeaf-E
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04495725
Chemically-Induced Disorders, Chronic Pain
Queens, New York, United States
View Trial DetailsNCT03268551
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
The Bronx, New York, United States
View Trial DetailsNCT05351905
Cannabis, Chemically-Induced Disorders
Toronto, Ontario, Canada
View Trial DetailsNCT06008496
Chronic Pain, Neurologic Manifestations
Plymouth, Devon, United Kingdom
View Trial Details