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OpenTrials
Completed

NCT Number: NCT02205983

The Effects of Hydromorphone on Responses to Verbal Tasks

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Hospital

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2 mg hydromorphone

Drug

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

1000 mg acetaminophen

Drug

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

4 mg hydromorphone

Drug

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

Dextrose

Drug

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

Primary outcomes

  1. Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire

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

    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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: HESS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 1, 2014
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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