The Effects of Buprenorphine on Responses to Verbal Tasks

May 30, 2019 updated by: University of Chicago
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo group
Healthy volunteers receive placebo during session (within-subjects design).
Drug: Placebo
This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive a placebo
EXPERIMENTAL: buprenorphine (0.2 mg) group
Healthy volunteers receive buprenorphine (0.2 mg) during session (within-subjects design).
Drug: 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)
EXPERIMENTAL: buprenorphine (0.4 mg) group
Healthy volunteers receive buprenorphine (0.4 mg) during session (within-subjects design).
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine
Time Frame: End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shown
The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0 -100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shown

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Harriet de Wit, Ph.D., University of Chicago
  • Study Chair: Jerome Jaffe, M.D., University of Maryland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

May 6, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (ESTIMATE)

May 22, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2019

Last Update Submitted That Met QC Criteria

May 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCIRB-130197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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