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Clinical Trials/NCT01860287
NCT01860287CompletedEarly Phase 1

The Effects of Buprenorphine on Responses to Verbal Tasks

University of Chicago1 site in 1 country48 target enrollmentStarted: September 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
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

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • night shift workers
  • drink more than 4 alcoholic or caffeinated drinks per day

Arms & Interventions

Placebo group

Placebo Comparator

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

Intervention: Placebo (Drug)

buprenorphine (0.2 mg) group

Experimental

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

Intervention: Buprenorphine 0.2 MG Sublingual Tablet (Drug)

buprenorphine (0.4 mg) group

Experimental

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

Intervention: Buprenorphine 0.4 MG Sublingual Tablet (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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