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Trial · NCT02737826

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercentage of Patients Who Tolerate Buprenorphine Initiation8 hours post doseParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants Who Achieve Opioid Cessation8 weeks after stabilization at Week 10ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Who Achieve Opioid Cessation Post-taper: 1 Month1 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.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPain Self-report: Pain Catastrophizing Scale - BaselineBaseline
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 scaleMEAN
SECONDARYPain Laboratory Testing: Mechanical - BaselineBaselineOne 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 secondMEAN
SECONDARYMean Score of Current Opioid Measure (COMM)BaselineOne person erroneously randomized to placebo before eligible for induction and who never completed buprenorphine induction not considered in this analysis.units on a scaleMEAN
SECONDARYMean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PHbaseline
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 scaleMEAN
SECONDARYMean Score Pittsburgh Sleep Quality IndexbaselineOne person erroneously randomized not includedunits on a scaleMEAN
SECONDARYMean Score of Subjective Opioid Withdrawal Scale (SOWS)baselineunits on a scaleMEAN
SECONDARYNumber of Participants Who Achieved Opioid Cessation Post-taper - 3 MonthsPost-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.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Who Achieved Opioid Cessation Post-taper - 6 MonthsPost-taper - 6 monthsOne 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.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Who Achieved Opioid Cessation Post-taper - 12 MonthsPost-taper - 12 monthsOne person in the Gabapentin + Buprenorphine Taper Arm and Zero people in the Placebo + Buprenorphine Taper Arm completed the study buprenorphine taper.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPain Laboratory Measures - Descending Noxious Inhibitory Control (DNIC) - Average, BaselineBaselineOne person was erroneously randomized to placebo before eligible for randomization, and never completed buprenorphine induction, so they are not considered in this analysis.percentage of changeMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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