The Effects of Hydromorphone on Responses to Verbal Tasks

N/ACompletedNCT02205983

University of Chicago50 enrolled

Overview

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.

Participants be randomly assigned to receive 1000 mg acetaminophen, 2mg hydromorphone, 4mg hydromorphone, or placebo at each of two sessions; one during which they well participate in a stressful speaking task, and one during which they'll participate in a nonstressful control task. Physiological and subjective measures will be taken throughout each session.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy

2 mg hydromorphoneDRUG

We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.

1000 mg AcetaminophenDRUG

We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.

4 mg hydromorphoneDRUG

We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.

dextroseDRUG

We are administering dextrose to healthy volunteers for our placebo group.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adult volunteers Exclusion Criteria: 1. any current medical condition requiring medication or abnormal electrocardiogram 2. current or past medical condition considered to be a contraindication for the study conditions 3. 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 4. less than high school education 5. lack of fluency in English 6. night shift work 7. Pregnancy, lactation or plans to become pregnant. 8. Use of hormonal contraception. 9. Daily cigarette smokers i.e., \>7 cigarettes per week

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

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", "Like Drug", 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. The values shown below are only from week 4

Time frame: End of study (time 0 and approximately 4 weeks later), week 4 reported.