The Effects of Hydromorphone on Responses to Verbal Tasks

NCT ID: NCT02205983

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-09-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

2 mg hydromophone

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.

Group Type: EXPERIMENTAL

2 mg hydromorphone

Intervention Type: DRUG

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

4 mg hydromphone

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

Group Type: EXPERIMENTAL

4 mg hydromorphone

Intervention Type: DRUG

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

1000 mg acetaminophen

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.

Group Type: EXPERIMENTAL

1000 mg Acetaminophen

Intervention Type: DRUG

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

Dextrose

Healthy adult volunteers will recieve Dextrose (placebo).

Group Type: PLACEBO_COMPARATOR

dextrose

Intervention Type: DRUG

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

Interventions

2 mg hydromorphone

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

Intervention Type: DRUG

1000 mg Acetaminophen

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

Intervention Type: DRUG

4 mg hydromorphone

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

Intervention Type: DRUG

dextrose

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harriet de Wit, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Jerome Jaffe, MD

Role: STUDY_CHAIR

University of Maryland

Locations

University of Chicago Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

R01DA002812

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UC13-1027

Identifier Type: -

Identifier Source: org_study_id