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Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper

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ClinicalTrials.gov Identifier: NCT02737826
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Opioid Pain Medication Drug: Buprenorphine - Phase I Drug: Gabapentin - Phase II Drug: Placebo - Phase II Drug: Buprenorphine taper - Phase II Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
Study Start Date : May 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase - Buprenorphine Initiation
In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol. "Buprenorphine tolerability" will be defined as pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper.
Drug: Buprenorphine - Phase I
In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol.

Active Comparator: Phase II - Gabapentin
Subjects who tolerate buprenorphine initiation in Phase I (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.
Drug: Buprenorphine - Phase I
In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol.

Drug: Gabapentin - Phase II
Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.

Drug: Placebo - Phase II
Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.

Placebo Comparator: Phase II - Placebo
Subjects who tolerate buprenorphine initiation in Phase I (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.
Drug: Buprenorphine - Phase I
In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol.

Drug: Gabapentin - Phase II
Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.

Drug: Placebo - Phase II
Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.

Experimental: Phase II - Buprenorphine taper
Subjects who tolerate buprenorphine initiation in Phase I (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.
Drug: Gabapentin - Phase II
Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.

Drug: Placebo - Phase II
Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.

Drug: Buprenorphine taper - Phase II
Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.




Primary Outcome Measures :
  1. Percentage of patients who tolerate buprenorphine initiation [ Time Frame: 8 hours ]
    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.

  2. Opioid cessation [ Time Frame: 8 weeks ]
    For Phase II, the primary outcome measure will be opioid cessation at 8 weeks, 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737826


Contacts
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Contact: Kayla Research Specialist 843-792-0684 whaley@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29424
Contact: Kayla Research Specialist         
Principal Investigator: Kelly Barth, DO         
Sponsors and Collaborators
Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02737826     History of Changes
Other Study ID Numbers: Pro00046473
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Buprenorphine
Gabapentin
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents