The Effects of Hydromorphone on Responses to Verbal Tasks

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Hydromorphone on Responses to Verbal Tasks

Conditions
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Healthy

Intervention / Treatment
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* Drug: 2 mg hydromorphone
* Drug: 1000 mg Acetaminophen
* Drug: 4 mg hydromorphone
* Drug: dextrose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 mg hydromophone<br>Healthy 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. | Drug: 2 mg hydromorphone<br>* We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.<br>|
| Experimental: 4 mg hydromphone<br>Healthy 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 | Drug: 4 mg hydromorphone<br>* We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.<br>|
| Experimental: 1000 mg acetaminophen<br>Healthy 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. | Drug: 1000 mg Acetaminophen<br>* We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.<br>|
| Placebo Comparator: Dextrose<br>Healthy adult volunteers will recieve Dextrose (placebo). | Drug: dextrose<br>* We are administering dextrose to healthy volunteers for our placebo group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | End of study (time 0 and approximately 4 weeks later), week 4 reported. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enrolling, adult, volunteers