Trial · NCT02737826
Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
NCT02737826, Not applicable, Completed, Medical University of South Carolina; results first posted 2021-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper. Trials, record NCT02737826. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02737826
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
- NCT number
- NCT02737826
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 32 participants, actual
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Chronic Pain, Opioid Pain Medication
- Interventions
- Buprenorphine Initiation - Phase I, Gabapentin + Buprenorphine - Phase II, Placebo + Buprenorphine - Phase II, Buprenorphine taper - Phase II
- First posted
- 2016-04-14
- Last updated
- 2022-12-01
- Results first posted
- 2021-04-13
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Who Tolerate Buprenorphine Initiation | 8 hours post dose | 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. |
| Primary | Number of Participants Who Achieve Opioid Cessation | 8 weeks after stabilization at Week 10 | 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. |
| Secondary | Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month | 1 month post-taper | 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. |
| Secondary | Pain Self-report: Pain Catastrophizing Scale - Baseline | 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. |
| Secondary | Pain Laboratory Testing: Mechanical - Baseline | 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. |
| Secondary | Mean Score of Current Opioid Measure (COMM) | Baseline | 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. |
| Secondary | Mean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PH | baseline | 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 |
| Secondary | Mean Score Pittsburgh Sleep Quality Index | baseline | 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. |
| Secondary | Mean Score of Subjective Opioid Withdrawal Scale (SOWS) | baseline | 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. |
| Secondary | Number of Participants Who Achieved Opioid Cessation Post-taper - 3 Months | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Who Tolerate Buprenorphine Initiation | 8 hours post dose | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Who Achieve Opioid Cessation | 8 weeks after stabilization at Week 10 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month | 1 month post-taper | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pain Self-report: Pain Catastrophizing Scale - Baseline | Baseline | 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. | units on a scale | MEAN |
| SECONDARY | Pain Laboratory Testing: Mechanical - Baseline | Baseline | 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. | grams per second | MEAN |
| SECONDARY | Mean Score of Current Opioid Measure (COMM) | Baseline | One person erroneously randomized to placebo before eligible for induction and who never completed buprenorphine induction not considered in this analysis. | units on a scale | MEAN |
| SECONDARY | Mean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PH | baseline | 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. | units on a scale | MEAN |
| SECONDARY | Mean Score Pittsburgh Sleep Quality Index | baseline | One person erroneously randomized not included | units on a scale | MEAN |
| SECONDARY | Mean Score of Subjective Opioid Withdrawal Scale (SOWS) | baseline | units on a scale | MEAN | |
| SECONDARY | Number of Participants Who Achieved Opioid Cessation Post-taper - 3 Months | Post-taper - 3 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Who Tolerate Buprenorphine Initiation | Phase I - Buprenorphine Initiation | 27 | Participants | ||
| Number of Participants Who Achieve Opioid Cessation | Phase II - Gabapentin + Buprenorphine Taper | 1 | Participants | ||
| Number of Participants Who Achieve Opioid Cessation | Phase II - Placebo + Buprenorphine Taper | 0 | Participants | ||
| Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month | Gabapentin + Buprenorphine Taper - Opioid Cessation 1 Month Post-taper | 0 | Participants | ||
| Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month | Placebo + Buprenorphine Taper - Opioid Cessation 1 Month Post-taper | 0 | Participants | ||
| Pain Self-report: Pain Catastrophizing Scale - Baseline | Gabapentin + Buprenorphine Taper | 21.9 | Full Range 3 to 39 | units on a scale | |
| Pain Self-report: Pain Catastrophizing Scale - Baseline | Placebo + Buprenorphine Taper | 21.2 | Full Range 0 to 48 | units on a scale | |
| Pain Laboratory Testing: Mechanical - Baseline | Gabapentin + Buprenorphine Taper | 284.2 | Full Range 113.7 to 482.7 | grams per second | |
| Pain Laboratory Testing: Mechanical - Baseline | Placebo + Buprenorphine Taper | 289.1 | Full Range 163.6 to 627.3 | grams per second | |
| Mean Score of Current Opioid Measure (COMM) | Gabapentin + Buprenorphine Taper | 16 | Full Range 1 to 41 | units on a scale |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I - Buprenorphine Initiation | STARTED | Phase I - Buprenorphine Initiation | 27 | |
| Phase I - Buprenorphine Initiation | STARTED | Phase II - Gabapentin + Buprenorphine Taper | 0 | |
| Phase I - Buprenorphine Initiation | STARTED | Phase II - Placebo + Buprenorphine Taper | 0 | |
| Phase I - Buprenorphine Initiation | COMPLETED | Phase I - Buprenorphine Initiation | 27 | |
| Phase I - Buprenorphine Initiation | COMPLETED | Phase II - Gabapentin + Buprenorphine Taper | 0 | |
| Phase I - Buprenorphine Initiation | COMPLETED | Phase II - Placebo + Buprenorphine Taper | 0 | |
| Phase I - Buprenorphine Initiation | NOT COMPLETED | Phase I - Buprenorphine Initiation | 0 | |
| Phase I - Buprenorphine Initiation | NOT COMPLETED | Phase II - Gabapentin + Buprenorphine Taper | 0 | |
| Phase I - Buprenorphine Initiation | NOT COMPLETED | Phase II - Placebo + Buprenorphine Taper | 0 | |
| Phase II - Randomization + Taper | STARTED | Phase I - Buprenorphine Initiation | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Increased Pain | Musculoskeletal and connective tissue disorders | Phase I - Buprenorphine Initiation | 0 | 27 | 0 |
| other | Increased Pain | Musculoskeletal and connective tissue disorders | Phase II - Gabapentin + Buprenorphine | 4 | 13 | 7 |
| other | Increased Pain | Musculoskeletal and connective tissue disorders | Phase II - Gabapentin + Placebo | 5 | 14 | 9 |
| other | Increased Pain | Musculoskeletal and connective tissue disorders | Phase II - Buprenorphine Taper | 0 | 27 | 0 |
| other | Nausea | Gastrointestinal disorders | Phase I - Buprenorphine Initiation | 2 | 27 | 2 |
| other | Nausea | Gastrointestinal disorders | Phase II - Gabapentin + Buprenorphine | 4 | 13 | 8 |
| other | Nausea | Gastrointestinal disorders | Phase II - Gabapentin + Placebo | 4 | 14 | 7 |
| other | Nausea | Gastrointestinal disorders | Phase II - Buprenorphine Taper | 0 | 27 | 0 |
| other | Dry Mouth | General disorders | Phase I - Buprenorphine Initiation | 0 | 27 | 0 |
| other | Dry Mouth | General disorders | Phase II - Gabapentin + Buprenorphine | 3 | 13 | 5 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I - Buprenorphine Initiation | 0 | 27 |
| Total, all-cause mortality | Phase II - Gabapentin + Buprenorphine | 0 | 13 |
| Total, all-cause mortality | Phase II - Gabapentin + Placebo | 0 | 14 |
| Total, all-cause mortality | Phase II - Buprenorphine Taper | 0 | 27 |
| Total, other adverse events | Phase I - Buprenorphine Initiation | 2 | 27 |
| Total, other adverse events | Phase II - Gabapentin + Buprenorphine | 12 | 13 |
| Total, other adverse events | Phase II - Gabapentin + Placebo | 12 | 14 |
| Total, other adverse events | Phase II - Buprenorphine Taper | 0 | 27 |
| Total, serious adverse events | Phase I - Buprenorphine Initiation | 0 | 27 |
| Total, serious adverse events | Phase II - Gabapentin + Buprenorphine | 0 | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Phase II - Gabapentin + Buprenorphine Taper vs Phase II - Placebo + Buprenorphine Taper: Number of Participants Who Achieve Opioid Cessation |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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