The Effects of Buprenorphine on Responses to Verbal Tasks

Early Phase 1

Completed

• Conditions: Basic Science
• Interventions: Drug: Placebo; Drug: Buprenorphine 0.2 MG Sublingual Tablet; Drug: Buprenorphine 0.4 MG Sublingual Tablet

• Registration Number: NCT01860287
• Lead Sponsor: University of Chicago

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-22
• Study Start: 2013-09
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2019-04
• Results First Submitted: 2019-04-04
• Results First Submitted QC: 2019-05-30
• Last Update Submitted: 2019-05-30
• Results First Posted: 2019-08-01
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Healthy volunteers receive placebo during session (within-subjects design).
buprenorphine (0.2 mg) group	Buprenorphine 0.2 MG Sublingual Tablet	Healthy volunteers receive buprenorphine (0.2 mg) during session (within-subjects design).
buprenorphine (0.4 mg) group	Buprenorphine 0.4 MG Sublingual Tablet	Healthy volunteers receive buprenorphine (0.4 mg) during session (within-subjects design).

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States