The Effects of Buprenorphine on Responses to Verbal Tasks

The University of Chicago

Status and phase: Completed; Early Phase 1

Conditions: Basic Science

Treatments: Drug: Buprenorphine 0.2 MG Sublingual Tablet; Drug: Buprenorphine 0.4 MG Sublingual Tablet; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01860287

UCIRB-130197

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

buprenorphine (0.2 mg) group

Experimental group

Description:

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

Treatment:

Drug: Buprenorphine 0.2 MG Sublingual Tablet

buprenorphine (0.4 mg) group

Experimental group

Description:

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

Treatment:

Drug: Buprenorphine 0.4 MG Sublingual Tablet