At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 328 enrolled
Drug / intervention
Buprenorphine transdermal patch +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Triple-blind, Placebo- and Positive-Controlled, Parallel Group Study of the Effect of Buprenorphine Delivered by the Buprenorphine Transdermal System (BTDS) at Doses up to 80 mcg/Hour and Naltrexone on ECG Intervals in Healthy Adult Subjects
In Brief
A Phase 1 clinical trial evaluating Buprenorphine transdermal patch, Naltrexone tablet, and 2 other interventions for ECG Effects. Completed, enrolled 328 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsECG Effects
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2012
Primary CompletionOct 2012
First PostedDec 2013
TodayJul 2026
First PostedDec 3, 2013
Enrollment StartMar 1, 2012
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.6 years ago
Interventions
Buprenorphine transdermal patchdrug
Buprenorphine patch applied transdermally
Naltrexone tabletdrug
Naltrexone tablet; 1 tablet taken orally every 12 hours
Placebos (for TDS and for naltrexone and for moxifloxacin)drug
Matching placebos
Moxifloxacin tabletdrug
Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17