N/A
N=27
Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
Chronic Pain · Opioid Pain Medication
Bottom Line
View on ClinicalTrials.gov: NCT02737826 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Percentage of Patients Who Tolerate Buprenorphine Initiation — 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Buprenorphine Initiation - Phase I (Drug); Gabapentin + Buprenorphine - Phase II (Drug); Placebo + Buprenorphine - Phase II (Drug); Buprenorphine taper - Phase II (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Tolerate Buprenorphine Initiation |
27 | — |
| PRIMARY Number of Participants Who Achieve Opioid Cessation |
1; 0 | — |
| SECONDARY Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month |
0; 0 | — |
| SECONDARY Pain Self-report: Pain Catastrophizing Scale - Baseline |
21.9; 21.2 | — |
| SECONDARY Pain Laboratory Testing: Mechanical - Baseline |
284.2; 289.1 | — |
| SECONDARY Mean Score of Current Opioid Measure (COMM) |
16; 15 | — |
| SECONDARY Mean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PH |
10.3; 11 | — |
| SECONDARY Mean Score Pittsburgh Sleep Quality Index |
12.5; 10.6 | — |
| SECONDARY Mean Score of Subjective Opioid Withdrawal Scale (SOWS) |
17.3; 11.9 | — |
| SECONDARY Number of Participants Who Achieved Opioid Cessation Post-taper - 3 Months |
1; 0 | — |
| SECONDARY Number of Participants Who Achieved Opioid Cessation Post-taper - 6 Months |
1; 0 | — |
| SECONDARY Number of Participants Who Achieved Opioid Cessation Post-taper - 12 Months |
1; 0 | — |
| SECONDARY Pain Laboratory Measures - Descending Noxious Inhibitory Control (DNIC) - Average, Baseline |
312.5; 326.4 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02737826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.