CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 48 enrolled
Drug / intervention
Buprenorphine 0.2 MG Sublingual Tablet +2 moredrug
Likely dose
Buprenorphine 0.2 MG Sublingual Tabletfrom 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.

Search/NCT01860287
NCT01860287Early Ph 1Completed

The Effects of Buprenorphine on Responses to Verbal Tasks

University of Chicago·interventional·Posted May 22, 2013·Updated Aug 1, 2019

In Brief

A Early Phase 1 clinical trial evaluating Buprenorphine 0.2 MG Sublingual Tablet, Placebo, and 1 other intervention for Basic Science. Completed, enrolled 48 participants across 1 site.

Detailed Summary

In this study, the investigators will examine the effects of buprenorphine, as compared to placebo, upon physiological, subjective, and hormonal responses to a stressful speech task and a non-stressful control task in healthy adults. There is strong evidence in support of the role of endogenous opioids and opiates in mediating social behavior in humans and other animals, and particularly, in social distress. Recently it has been shown that buprenorphine, a partial mu-opioid agonist, reduces sensitivity to recognition of fearful facial expressions in humans. Here, the investigators propose to further explore the role of the opioid system in mediating stress responses in humans through the use of buprenorphine. The investigators hypothesize that buprenorphine with reduce both physiological and subjective measures of stress.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBasic Science
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 22, 2013
Enrollment StartSep 1, 2013
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.1 years ago

Interventions

Buprenorphine 0.2 MG Sublingual Tabletdrug

This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.2)

Placebodrug

This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive a placebo

Buprenorphine 0.4 MG Sublingual Tabletdrug

This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.4)