The Effects of Buprenorphine on Responses to Verbal Tasks
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- University of Chicago
- 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
Healthy volunteers receive placebo during session (within-subjects design).
Intervention: Placebo (Drug)
buprenorphine (0.2 mg) group
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
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