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

• ClinicalTrials.gov Identifier: NCT02205983
• Recruitment Status: Completed
• First Posted: August 1, 2014
• Results First Posted: October 9, 2018
• Last Update Posted: October 9, 2018
• Sponsor: University of Chicago
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): University of Chicago

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: 2 mg hydromorphone; Drug: 1000 mg Acetaminophen; Drug: 4 mg hydromorphone; Drug: dextrose	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: The Effects of Hydromorphone on Responses to Verbal Tasks
• Actual Study Start Date: January 2015
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: 2 mg hydromorphone; We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.
Experimental: 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	Drug: 4 mg hydromorphone; We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.
Experimental: 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.	Drug: 1000 mg Acetaminophen; We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.
Placebo Comparator: Dextrose; Healthy adult volunteers will recieve Dextrose (placebo).	Drug: dextrose; We are administering dextrose to healthy volunteers for our placebo group.

Outcome Measures

Primary Outcome Measures :

1. Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire [ Time Frame: End 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Illinois

University of Chicago Hospital

Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Harriet de Wit, PhD; University of Chicago
• Study Chair: Jerome Jaffe, MD; University of Maryland

More Information

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT02205983
• Other Study ID Numbers: UC13-1027; R01DA002812 ( U.S. NIH Grant/Contract )
• First Posted: August 1, 2014
• Results First Posted: October 9, 2018
• Last Update Posted: October 9, 2018
• Last Verified: September 2018

Keywords provided by University of Chicago:

enrolling; adult; volunteers

Additional relevant MeSH terms:

Acetaminophen; Hydromorphone; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics; Analgesics, Opioid; Narcotics; Central Nervous System Depressants