The Effects of Buprenorphine on Responses to Verbal Tasks

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Basic Science

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo group

Healthy volunteers receive placebo during session (within-subjects design).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

buprenorphine (0.2 mg) group

Healthy volunteers receive buprenorphine (0.2 mg) during session (within-subjects design).

Group Type EXPERIMENTAL

Buprenorphine 0.2 MG Sublingual Tablet

Intervention Type DRUG

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

buprenorphine (0.4 mg) group

Healthy volunteers receive buprenorphine (0.4 mg) during session (within-subjects design).

Group Type EXPERIMENTAL

Buprenorphine 0.4 MG Sublingual Tablet

Intervention Type DRUG

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

Interventions

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Buprenorphine 0.2 MG Sublingual Tablet

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Buprenorphine 0.4 MG Sublingual Tablet

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy men and women
* ages 18-40 years
* high school education
* fluent in English

Exclusion Criteria

* history of adverse drug reactions
* taking oral contraceptives or planning to become pregnant
* taking any medications
* smokers
* night shift workers
* drink more than 4 alcoholic or caffeinated drinks per day

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes