- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02737826
Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29424
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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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.
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Active Comparator: 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.
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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.
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Placebo Comparator: 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.
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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.
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Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Patients Who Tolerate Buprenorphine Initiation
Time Frame: 8 hours post dose
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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.
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8 hours post dose
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Number of Participants Who Achieve Opioid Cessation
Time Frame: 8 weeks after stabilization at Week 10
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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.
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8 weeks after stabilization at Week 10
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month
Time Frame: 1 month post-taper
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Opioid cessation post taper: 1 month with opioid cessation measured through self-report, prescription drug monitoring data, and confirmatory UDS for a full panel of opioids.
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1 month post-taper
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Pain Self-report: Pain Catastrophizing Scale - Baseline
Time Frame: Baseline
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The Self Reporting Pain Catastrophizing scale consists of 13 items scored from 0 to 4. The total possible score is 52.
A higher score indicates more catastrophizing thoughts are present.
A lower score indicates less catastrophizing thoughts.
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Baseline
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Pain Laboratory Testing: Mechanical - Baseline
Time Frame: Baseline
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Mechanical (Pressure) Pain Threshold Assessment (PPTh): A digital anesthesiometer (IITC Life Sciences ElectroVonFrey) will be used to assess mechanical pain perception.
Pain threshold to static mechanical stimuli will be determined by applying the rigid monofilament to the dorsum of each subject's right hand with increasing pressure (10 grams per second) until the participant indicates verbally that the pain threshold has been reached.
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Baseline
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Mean Score of Current Opioid Measure (COMM)
Time Frame: Baseline
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COMM is a 17 item questionnaire that is used to examine concurrent misuse.
The score range is from 0-28.
A lower score represents participant showing less aberrant behaviors associates with misuse of option medications, and a higher score represents more aberrant behaviors associated with opioid medical misuse.
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Baseline
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Mean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PH
Time Frame: baseline
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The Mean score of Physical Function on PROMIS short form. The global physical health score is a sum of responses to 4 questions. The range is from 4-20. A lower score represents lower physical function. The following questions will be asked: In general, how would you rate your physical health? (range is 1-5; 1 represents poor rating in health, 5 represents excellent rating of physical health) To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, carrying groceries, or moving a chair? (range is 1-5; 1 represents score of not at all, 5 represents score of completely) How would you rate your fatigue on average? (range is 1-5; 1 represents very severe fatigue, and 5 represents no fatigue) How would you rate your pain on average (range is 0-10; 0 represents no pain, 10 represents worst pain imaginable). The pain score is then recoded: 0, no pain = 5; 1, 2, or 3 = 4; 4, 5, or 6 =3; 7, 8, 9 =2;10 =1 |
baseline
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Mean Score Pittsburgh Sleep Quality Index
Time Frame: baseline
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The PSQI is a 19 item self-report questionnaire that assesses sleep quality over a 1-month time interval.
The measure consists of 19 individual items, creating 7 components (time gone to bed, how long it takes to go to sleep, wake up time, hours slept, issues sleeping, total hours slept etc.) that produce one global score.
Each item is weighted on a 0-3 interval scale.
The global score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, A lower scale is indicative of better sleep quality and higher score represents poor sleep quality.
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baseline
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Mean Score of Subjective Opioid Withdrawal Scale (SOWS)
Time Frame: baseline
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The Subjective Opiate Withdrawal Scale (SOWS) consist of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely.
The total score is a sum of item ratings, and ranges from 0 to 64.
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baseline
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Number of Participants Who Achieved Opioid Cessation Post-taper - 3 Months
Time Frame: Post-taper - 3 months
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Opioid cessation is 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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Post-taper - 3 months
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Number of Participants Who Achieved Opioid Cessation Post-taper - 6 Months
Time Frame: Post-taper - 6 months
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Opioid cessation is 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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Post-taper - 6 months
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Number of Participants Who Achieved Opioid Cessation Post-taper - 12 Months
Time Frame: Post-taper - 12 months
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Opioid cessation is 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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Post-taper - 12 months
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Pain Laboratory Measures - Descending Noxious Inhibitory Control (DNIC) - Average, Baseline
Time Frame: Baseline
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DNIC will be measured as the percent change in PPTh during the cold pressor tasks relative to baseline.
A percent increase represents normal functioning of pain inhibitory processes.
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Baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Chronic Pain
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Narcotic Antagonists
- Anticonvulsants
- Antimanic Agents
- Buprenorphine
- Gabapentin
Other Study ID Numbers
- Pro00046473
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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