Early Phase 1
Completed N=48
The Effects of Buprenorphine on Responses to Verbal Tasks
Basic Science
Source: ClinicalTrials.gov NCT01860287 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: 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 — 13.57; 36.57; 59.89; 9.4 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
13.57; 36.57; 59.89; 9.4; 43.27; 56.25 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01860287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.