The Effects of Buprenorphine on Responses to Verbal Tasks

NCT01860287 | Completed Early Phase 1 Results DMC

• 1 other identifier: UCIRB-130197
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Basic Science

Keywords

opioid; subjective; stress; buprenorphine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

buprenorphine (0.2 mg) group

EXPERIMENTAL

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

Drug: Buprenorphine 0.2 MG Sublingual Tablet

buprenorphine (0.4 mg) group

EXPERIMENTAL

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

Drug: Buprenorphine 0.4 MG Sublingual Tablet

Interventions

Buprenorphine 0.2 MG Sublingual Tablet DRUG

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

buprenorphine (0.2 mg) group

Placebo DRUG

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

Placebo group

Buprenorphine 0.4 MG Sublingual Tablet DRUG

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

buprenorphine (0.4 mg) group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Buprenorphine; Administration, Sublingual

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Administration, Oral; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Harriet de Wit
• Organization: University of Chicago

dewitlab@yoda.bsd.uchicago.edu

7737023560

Study Officials

• Harriet de Wit, Ph.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Jerome Jaffe, M.D.

  University of Maryland

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 22, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 1, 2019
• Results First Posted: August 1, 2019

Record last verified: 2019-04

Locations

US (1)