Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
CompletedNot applicableNCT02737826
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
- Conditions
- Chronic Pain
- Opioid Pain Medication
- Interventions
- Drug: Buprenorphine Initiation - Phase I
- Drug: Gabapentin + Buprenorphine - Phase II
- Drug: Placebo + Buprenorphine - Phase II
- Drug: Buprenorphine taper - Phase II
- Sponsor
- Medical University of South Carolina
- Start date
- 2016-05
- Primary completion
- 2019-12-09
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02737826