The Effects of Hydromorphone on Responses to Verbal Tasks

NCT02205983 | Completed Results

• 2 other identifiers: UC13-1027R01DA002812
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

enrolling; adult; volunteers

Outcome Measures

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

  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.

Study Arms (4)

2 mg hydromophone

EXPERIMENTAL

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

4 mg hydromphone

EXPERIMENTAL

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

1000 mg acetaminophen

EXPERIMENTAL

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

Dextrose

PLACEBO COMPARATOR

Healthy adult volunteers will recieve Dextrose (placebo).

Drug: dextrose

Interventions

2 mg hydromorphone DRUG

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

2 mg hydromophone

1000 mg Acetaminophen DRUG

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

1000 mg acetaminophen

4 mg hydromorphone DRUG

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

4 mg hydromphone

dextrose DRUG

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

Dextrose

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Hydromorphone; Acetaminophen; Glucose

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hexoses; Monosaccharides; Sugars; Carbohydrates

Results Point of Contact

• Title: Dr. Harriet de Wit
• Organization: University of Chicago

dewitlab@yoda.bsd.uchicago.edu

773-702-3560

Study Officials

• Harriet de Wit, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Jerome Jaffe, MD

  University of Maryland

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: August 1, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 9, 2018
• Results First Posted: October 9, 2018

Record last verified: 2018-09

Locations

US (1)