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NCT01860287 · ClinicalTrials.gov registry record · Early Phase 1
The Effects of Buprenorphine on Responses to Verbal Tasks
A Early Phase 1 study, sponsored by University of Chicago.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 48
- Enrollment target
NCT01860287: Completed Early Phase 1 study, sponsored by University of Chicago.
NCT01860287 is a Early Phase 1 study that has completed, run by University of Chicago. The registered enrollment target is 48 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01860287, a Early Phase 1 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 48 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Buprenorphine 0.2 MG Sublingual Tablet
- DRUG Buprenorphine 0.4 MG Sublingual Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-09 |
| Est. Completion | 2017-01 |
| Phase | Early Phase 1 |
What the finished NCT01860287 record still lists
NCT01860287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01860287 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01860287 about?
NCT01860287 is a clinical study titled "The Effects of Buprenorphine on Responses to Verbal Tasks". 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 opio...
What is the current status of trial NCT01860287?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 48 participants. The study started on 2013-09. Estimated completion is 2017-01.
What interventions are being tested in trial NCT01860287?
The interventions under investigation include: Placebo (DRUG), Buprenorphine 0.2 MG Sublingual Tablet (DRUG), Buprenorphine 0.4 MG Sublingual Tablet (DRUG).
Who is sponsoring clinical trial NCT01860287?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01860287's enrollment target sits among peer trials
48 541st of 2000 higher than 1,439 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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