Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper

• Status: Completed
• Trial end date: 2021-01-13
• Target enrollment: 0
• Participant gender: All

Summary

Chronic opioid therapy for pain can be associated with significant risks, and a significant number of patients maintained on chronic opioids have continued pain and/or poor functioning. When patients need to or want to come off their opioid pain medications, there is little to guide physicians as to how to best help them do so, and it is not known how patients do after coming off opioid medications. The goals of this study are (1) to evaluate two medications in assisting patients in coming off their opioid pain medications and (2) determining outcomes after discontinuing opioids.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Buprenorphine; Gabapentin; gamma-Aminobutyric Acid

Criteria

Inclusion Criteria:

• 18 - 70 years of age

• Ability to speak and read in English

• Currently taking chronic opioid therapy for pain for at least 6 months

• On opioid dose of >60mg and <200mg oral morphine equivalents/day

• Voluntarily seeking opioid discontinuation

• Willing to attempt buprenorphine-assisted opioid discontinuation

• Willing to be randomized to gabapentin or placebo

• Have current physician who is actively prescribing opioids and who will be notified by the research team of the patient's entry into the study.

Exclusion Criteria:

• Previous intolerance or allergy to buprenorphine or gabapentin

• Diagnostic & Statistical Manual -V criteria for substance use disorder currently or in the past (other than nicotine)

• Unstable medical or psychiatric condition that would preclude safe or meaningful participation (e.g. traumatic brain injury; severe mental illness; severe cardiac, renal, pulmonary, or liver disease)

• Current use of illicit drugs

• Maintenance on fentanyl or methadone

• Current treatment with gabapentin