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The Effects of Hydromorphone on Responses to Verbal Tasks

Not Applicable
Completed
Conditions
Healthy
Interventions
Drug: 2 mg hydromorphone
Drug: 4 mg hydromorphone
Registration Number
NCT02205983
Lead Sponsor
University of Chicago
Brief 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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
2 mg hydromophone2 mg hydromorphoneHealthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion.
4 mg hydromphone4 mg hydromorphoneHealthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion
1000 mg acetaminophen1000 mg AcetaminophenHealthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion.
DextrosedextroseHealthy adult volunteers will recieve Dextrose (placebo).
Primary Outcome Measures
NameTimeMethod
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects QuestionnaireEnd 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Chicago Hospital

🇺🇸

Chicago, Illinois, United States

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