Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Percentage of Patients Who Tolerate Buprenorphine Initiation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Phase - Buprenorphine Initiation
In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol up to 16mg sublingually over an up to 8 hour induction window. "Buprenorphine tolerability" will be defined as pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper.
Intervention: Buprenorphine Initiation - Phase I (Drug)
Phase II - Gabapentin + Buprenorphine
Subjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to gabapentin will receive up to 1600mg oral 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.
Intervention: Gabapentin + Buprenorphine - Phase II (Drug)
Phase II - Placebo + Buprenorphine
Subjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to placebo will receive up to 1600mg oral 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.
Intervention: Placebo + Buprenorphine - Phase II (Drug)
Phase II - Buprenorphine taper
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.
Intervention: Buprenorphine taper - Phase II (Drug)
Outcomes
Primary Outcomes
Percentage of Patients Who Tolerate Buprenorphine Initiation
Time Frame: 8 hours post dose
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.
Number of Participants Who Achieve Opioid Cessation
Time Frame: 8 weeks after stabilization at Week 10
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.
Secondary Outcomes
- Pain Self-report: Pain Catastrophizing Scale - Baseline(Baseline)
- Mean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PH(baseline)
- Number of Participants Who Achieved Opioid Cessation Post-taper - 3 Months(Post-taper - 3 months)
- Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month(1 month post-taper)
- Mean Score of Current Opioid Measure (COMM)(Baseline)
- Mean Score of Subjective Opioid Withdrawal Scale (SOWS)(baseline)
- Number of Participants Who Achieved Opioid Cessation Post-taper - 6 Months(Post-taper - 6 months)
- Pain Laboratory Testing: Mechanical - Baseline(Baseline)
- Mean Score Pittsburgh Sleep Quality Index(baseline)
- Number of Participants Who Achieved Opioid Cessation Post-taper - 12 Months(Post-taper - 12 months)
- Pain Laboratory Measures - Descending Noxious Inhibitory Control (DNIC) - Average, Baseline(Baseline)