Clinical trial NCT02737826: Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
Official title: Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Opioid Pain Medication
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Patients Who Tolerate Buprenorphine Initiation
timeFrame: 8 hours post dose
measure: Number of Participants Who Achieve Opioid Cessation
timeFrame: 8 weeks after stabilization at Week 10
Secondary outcomes:
measure: Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month
timeFrame: 1 month post-taper
measure: Pain Self-report: Pain Catastrophizing Scale - Baseline
timeFrame: Baseline
measure: Pain Laboratory Testing: Mechanical - Baseline
timeFrame: Baseline
measure: Mean Score of Current Opioid Measure (COMM)
timeFrame: Baseline
measure: Mean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PH
timeFrame: baseline
measure: Mean Score Pittsburgh Sleep Quality Index
timeFrame: baseline
measure: Mean Score of Subjective Opioid Withdrawal Scale (SOWS)
timeFrame: baseline
measure: Number of Participants Who Achieved Opioid Cessation Post-taper - 3 Months
timeFrame: Post-taper - 3 months
measure: Number of Participants Who Achieved Opioid Cessation Post-taper - 6 Months
timeFrame: Post-taper - 6 months
measure: Number of Participants Who Achieved Opioid Cessation Post-taper - 12 Months
timeFrame: Post-taper - 12 months
measure: Pain Laboratory Measures - Descending Noxious Inhibitory Control (DNIC) - Average, Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: