N/A
N=50
The Effects of Hydromorphone on Responses to Verbal Tasks
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02205983 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire — 7.41; 14.75; 28; 5.76 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 2 mg hydromorphone (Drug); 1000 mg Acetaminophen (Drug); 4 mg hydromorphone (Drug); dextrose (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Jul 2016
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 |
7.41; 14.75; 28; 5.76; 25.9; 35.58 | — |
Summary
In this study, the investigators will examine the effects of hydromorphone, 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. The investigators have recently shown that buprenorphine, a partial mu-opioid agonist, reduces cortisol responses to stress. Here, the investigators propose to further explore the role of the opioid system in mediating stress responses in humans through the use of hydromorphone, a full mu opioid agonist, in addition to acetaminophen. The investigators hypothesize that like acetaminophen, hydromorphone will reduce both physiological and subjective measures of stress.
Eligibility Criteria
Inclusion Criteria
- Healthy adult volunteers
Exclusion Criteria
- any current medical condition requiring medication or abnormal electrocardiogram
- current or past medical condition considered to be a contraindication for the study conditions
- any current Axis I psychiatric disorder (APA, 1994) including Substance Use Disorder, or Anxiety Disorder or Major Depression in the past year, any history of psychosis
- less than high school education
- lack of fluency in English
- night shift work
- Pregnancy, lactation or plans to become pregnant.
- Use of hormonal contraception.
- Daily cigarette smokers i.e., >7 cigarettes per week
Data sourced from ClinicalTrials.gov (NCT02205983). 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.