The Effects of Buprenorphine on Responses to Verbal Tasks

Basic Science Clinical Trial

Official title:

The Effects of Buprenorphine on Responses to Verbal Tasks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860287
• Other study ID #: UCIRB-130197
• Status: Completed
• Phase: Early Phase 1
• Start date: September 2013
• Est. completion date: January 2017

Study information

• Verified date: April 2019
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Basic Science

Intervention

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

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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