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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month | 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. | 1 month post-taper |
| Pain Self-report: Pain Catastrophizing Scale - Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29424 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I - Buprenorphine Initiation | In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol using up to 16mg of buprenoprhine 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. Buprenorphine - Phase I: In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase I - Buprenorphine Initiation |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2018 |
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| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
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. |
| Baseline |
| Pain Laboratory Testing: Mechanical - Baseline | 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. | Baseline |
| Mean Score of Current Opioid Measure (COMM) | 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. | Baseline |
| Mean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PH | 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 |
| Mean Score Pittsburgh Sleep Quality Index | 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. | baseline |
| Mean Score of Subjective Opioid Withdrawal Scale (SOWS) | 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. | baseline |
| Number of Participants Who Achieved Opioid Cessation Post-taper - 3 Months | 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. | Post-taper - 3 months |
| Number of Participants Who Achieved Opioid Cessation Post-taper - 6 Months | 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. | Post-taper - 6 months |
| Number of Participants Who Achieved Opioid Cessation Post-taper - 12 Months | 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. | Post-taper - 12 months |
| Pain Laboratory Measures - Descending Noxious Inhibitory Control (DNIC) - Average, Baseline | 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. | Baseline |
| FG001 | Phase II - Gabapentin + 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, 2 week stabilization period where buprenorphine will be titrated up as tolerated/needed to a maximum of 24 mg/day and gabapentin will be titrated up to 1600mg/day in 3 daily doses as tolerated. After the 2 week stabilization period, buprenorphine tapering will begin according to a tapering schedule that will last up to 8 weeks based on stabilizing buprenorphine dose. After the buprenorphine taper is complete, a 1 week taper of gabapentin will be provided. |
| FG002 | Phase II - Placebo + 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, 2 week stabilization period where buprenorphine will be titrated up as tolerated/needed to a maximum of 24 mg/day and placebo will be titrated up to 1600mg/day in 3 daily doses as tolerated. After the 2 week stabilization period, buprenorphine tapering will begin according to a tapering schedule that will last up to 8 weeks based on stabilizing buprenorphine dose. After the buprenorphine taper is complete, a 1 week taper of placebo will be provided. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Phase II - Randomization + Taper |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | 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. Buprenorphine - Phase I: In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 8 hours post dose |
|
|
| |||||||||||||||||||||||||||
| Primary | 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. | Posted | Count of Participants | Participants | 8 weeks after stabilization at Week 10 |
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month | 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. | Only one person in the Gabapentin + Buprenorphine Taper Arm completed the 8 week study buprenorphine taper, making them eligible for analysis for this secondary outcome measure. Zero people in the Placebo + Buprenorphne Taper Arm completed the study buprenorphine taper. | Posted | Count of Participants | Participants | 1 month post-taper |
|
| |||||||||||||||||||||||||||
| Secondary | Pain Self-report: Pain Catastrophizing Scale - Baseline | 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. | One consented and randomized participant in the Placebo + Buprenorphine Taper Arm was erroneously randomized prior to buprenorphine induction, and dropped out of the study on the day of induction prior to receiving first buprenorphine dose (prior to eligibility for randomization). This participant is not included in this analysis. | Posted | Mean | Full Range | units on a scale | Baseline |
|
| ||||||||||||||||||||||||||
| Secondary | Pain Laboratory Testing: Mechanical - Baseline | 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. | One person was erroneously randomized to placebo before they were eligible for randomization and dropped out prior to induction, so they are not considered in this analysis. | Posted | Mean | Full Range | grams per second | Baseline |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Score of Current Opioid Measure (COMM) | 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. | One person erroneously randomized to placebo before eligible for induction and who never completed buprenorphine induction not considered in this analysis. | Posted | Mean | Full Range | units on a scale | Baseline |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PH | 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 | This form was introduced after the first 2 participants had been randomized, so we only have this data for the 24 who were randomized after buprenorphine induction (vs n=26 for other outcome measures). One person was erroneously randomized prior to eligibility for randomization and was not included in calculations for these secondary outcomes. | Posted | Mean | Full Range | units on a scale | baseline |
| |||||||||||||||||||||||||||
| Secondary | Mean Score Pittsburgh Sleep Quality Index | 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. | One person erroneously randomized not included | Posted | Mean | Full Range | units on a scale | baseline |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Score of Subjective Opioid Withdrawal Scale (SOWS) | 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. | Posted | Mean | Full Range | units on a scale | baseline |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved Opioid Cessation Post-taper - 3 Months | 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. | One person in the Gabapentin + Buprenorphine Taper Arm completed the study buprenorphine taper and were eligible for analysis. Zero persons in the Placebo + Buprenorphine Taper Arm completed the study buprenoprhine taper and were eligible for analysis. | Posted | Count of Participants | Participants | Post-taper - 3 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved Opioid Cessation Post-taper - 6 Months | 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. | One person in the Gabapentin + Buprenorphine Taper Arm completed the study buprenorphine taper, and zero persons in the Placebo + Buprenorphine Taper Arm completed the study buprenorphine taper. | Posted | Count of Participants | Participants | Post-taper - 6 months |
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| Secondary | Number of Participants Who Achieved Opioid Cessation Post-taper - 12 Months | 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. | One person in the Gabapentin + Buprenorphine Taper Arm and Zero people in the Placebo + Buprenorphine Taper Arm completed the study buprenorphine taper. | Posted | Count of Participants | Participants | Post-taper - 12 months |
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| Secondary | Pain Laboratory Measures - Descending Noxious Inhibitory Control (DNIC) - Average, Baseline | 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. | One person was erroneously randomized to placebo before eligible for randomization, and never completed buprenorphine induction, so they are not considered in this analysis. | Posted | Mean | Full Range | percentage of change | Baseline |
|
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I - Buprenorphine Initiation | 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. | 0 | 27 | 0 | 27 | 2 | 27 |
| EG001 | Phase II - Gabapentin + Buprenorphine | 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. | 0 | 13 | 0 | 13 | 12 | 13 |
| EG002 | Phase II - Gabapentin + Placebo | 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. | 0 | 14 | 0 | 14 | 12 | 14 |
| EG003 | 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. | 0 | 27 | 0 | 27 | 0 | 27 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dry Mouth | General disorders | Non-systematic Assessment |
| ||
| Lower extremity swelling | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Insomnia | General disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Muscle twitching/spasm | Nervous system disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Sedation/sleepiness | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kelly Barth | Medical University of South Carolina | 843-792-0686 | stephen@musc.edu |
| Feb 23, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Phase II - Placebo + 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. Buprenorphine - Phase I: In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol. 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. 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. |
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| Placebo + Buprenorphine Taper |
Those randomized to Placebo during buprenorphine taper in Phase II after buprenorphine induction. |
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