The Effects of Buprenorphine on Responses to Verbal Tasks

Study Overview
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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.

Official Title
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The Effects of Buprenorphine on Responses to Verbal Tasks

Conditions
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Basic Science

Intervention / Treatment
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* Drug: Buprenorphine 0.2 MG Sublingual Tablet
* Drug: Placebo
* Drug: Buprenorphine 0.4 MG Sublingual Tablet


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Healthy volunteers receive placebo during session (within-subjects design). | Drug: Placebo<br>* This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive a placebo<br>|
| Experimental: buprenorphine (0.2 mg) group<br>Healthy volunteers receive buprenorphine (0.2 mg) during session (within-subjects design). | Drug: Buprenorphine 0.2 MG Sublingual Tablet<br>* This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.2)<br>|
| Experimental: buprenorphine (0.4 mg) group<br>Healthy volunteers receive buprenorphine (0.4 mg) during session (within-subjects design). | Drug: Buprenorphine 0.4 MG Sublingual Tablet<br>* This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.4)<br>|

What is the study measuring?
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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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress, opioid, subjective, buprenorphine