Completed
NA
INTERVENTIONAL
NCT02737826
Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
Buprenorphine Initiation - Phase I
Type:
DRUG
Description:
In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol up to 16mg sublingually over an 8 hour induction window.
Name:
Gabapentin + Buprenorphine - Phase II
Type:
DRUG
Description:
Subjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to oral gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to gabapentin will receive up to 1600mg gabapentin (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated.
Name:
Placebo + Buprenorphine - Phase II
Type:
DRUG
Description:
Subjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to oral gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to placebo will receive up to 1600mg placebo (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated.
Name:
Buprenorphine taper - Phase II
Type:
DRUG
Description:
After a 2 week stabilization period where sublingual buprenorphine is titrated up to 24 mg/day and oral gabapentin/placebo is titrated up to 1600mg/day, subjects will enter a buprenorphine tapering period lasting up to 8 weeks. The suggested buprenorphine taper will be determined by stabilizing dose, but able to be altered by prescriber or participant based on symptoms.
Primary Outcomes
Measure:
Percentage of Patients Who Tolerate Buprenorphine Initiation
TimeFrame:
8 hours post dose
Description:
For Phase I, the primary outcome measure is the percentage of patients who tolerate buprenorphine initiation within an 8-hour initiation period, as evidenced by a total score of 3 points when summing the following measures (1) moderate-good level of pain control (same or improved rating on a 0-10 visual analogue scale for pain) = 1 point, (2) mild to no withdrawal symptoms (≤10 on the Subjective Opioid Withdrawal Scale) = 1 point, and (3) willingness to continue to the stabilization and tapering phase of the study; "yes" = 1 point.
Measure:
Number of Participants Who Achieve Opioid Cessation
TimeFrame:
8 weeks after stabilization at Week 10
Description:
For Phase II, the primary outcome measure will be number of participants opioid who achieve cessation 8 weeks after stabilization at Week 10, evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point.
Trial Information
NCT ID
NCT02737826
Status
Completed
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Medical University of South Carolina
Last Updated
December 15, 2025