The Effects of Hydromorphone on Responses to Verbal Tasks (HESS)

The University of Chicago

Status: Completed

Conditions: Healthy

Treatments: Drug: 2 mg hydromorphone; Drug: 4 mg hydromorphone; Drug: dextrose; Drug: 1000 mg Acetaminophen

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02205983

R01DA002812 (U.S. NIH Grant/Contract)

UC13-1027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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50 participants in 4 patient groups, including a placebo group

2 mg hydromophone

Experimental group

Description:

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.

Treatment:

Drug: 2 mg hydromorphone

4 mg hydromphone

Experimental group

Description:

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

Treatment:

Drug: 4 mg hydromorphone

1000 mg acetaminophen

Experimental group

Description:

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.

Treatment:

Drug: 1000 mg Acetaminophen

Dextrose

Placebo Comparator group

Description:

Healthy adult volunteers will recieve Dextrose (placebo).

Treatment:

Drug: dextrose