Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Opioid Pain Medication; Chronic Pain

Treatments: Drug: Gabapentin + Buprenorphine - Phase II; Drug: Placebo + Buprenorphine - Phase II; Drug: Buprenorphine taper - Phase II; Drug: Buprenorphine Initiation - Phase I

Study type: Interventional

Funder types: Other

Identifiers

NCT02737826

Pro00046473

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 4 patient groups, including a placebo group

Phase - Buprenorphine Initiation

Experimental group

Description:

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.

Treatment:

Drug: Buprenorphine Initiation - Phase I

Phase II - Gabapentin + Buprenorphine

Active Comparator group

Description:

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.

Treatment:

Drug: Gabapentin + Buprenorphine - Phase II

Phase II - Placebo + Buprenorphine

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo + Buprenorphine - Phase II

Phase II - Buprenorphine taper

Experimental group

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.

Treatment:

Drug: Buprenorphine taper - Phase II