Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper

NCT02737826 | Completed Results DMC

• 1 other identifier: Pro00046473
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Opioid Pain Medication

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients Who Tolerate Buprenorphine Initiation

  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.

  8 hours post dose

• Number of Participants Who Achieve Opioid Cessation

  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.

  8 weeks after stabilization at Week 10

Secondary Outcomes (11)

• Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month

  1 month post-taper

• Pain Self-report: Pain Catastrophizing Scale - Baseline

  Baseline

• Pain Laboratory Testing: Mechanical - Baseline

  Baseline

• Mean Score of Current Opioid Measure (COMM)

  Baseline

• Mean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PH

  baseline

Study Arms (4)

Phase - Buprenorphine Initiation

EXPERIMENTAL

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.

Drug: Buprenorphine Initiation - Phase I

Phase II - Gabapentin + Buprenorphine

ACTIVE COMPARATOR

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.

Drug: Gabapentin + Buprenorphine - Phase II

Phase II - Placebo + Buprenorphine

PLACEBO COMPARATOR

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.

Drug: Placebo + Buprenorphine - Phase II

Phase II - Buprenorphine taper

EXPERIMENTAL

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.

Drug: Buprenorphine taper - Phase II

Interventions

Buprenorphine Initiation - Phase I DRUG

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.

Phase - Buprenorphine Initiation

Gabapentin + Buprenorphine - Phase II DRUG

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.

Phase II - Gabapentin + Buprenorphine

Placebo + Buprenorphine - Phase II DRUG

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.

Phase II - Placebo + Buprenorphine

Buprenorphine taper - Phase II DRUG

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.

Phase II - Buprenorphine taper

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29424, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Kelly Barth
• Organization: Medical University of South Carolina

stephen@musc.edu

843-792-0686

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: April 14, 2016
• Study Start: May 1, 2016
• Primary Completion: December 9, 2019
• Study Completion: January 13, 2021
• Last Updated: December 1, 2022
• Results First Posted: April 13, 2021

Record last verified: 2022-11

Locations

US (1)