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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA002812 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| 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. |
|
| Dextrose | Placebo Comparator | Healthy adult volunteers will recieve Dextrose (placebo). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 mg hydromorphone | Drug | We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task. |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harriet de Wit, PhD | University of Chicago | Principal Investigator |
| Jerome Jaffe, MD | University of Maryland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Hospital | Chicago | Illinois | 60637 | United States |
Participants were excluded if they had a serious medical condition, abnormal electrocardiogram, Axis I psychiatric disorder in the past year, or a history of psychosis. Subjects were also excluded if they had not completed high school, were not fluent in English, worked a night shift, used hormonal contraceptives, or were pregnant.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2 mg Hydromorphone | |
| FG001 | 4 mg Hydromorphone | |
| FG002 | 1000 mg Acetaminophen | |
| FG003 | Dextrose (Placebo) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 4 mg Hydromorphone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | End of study (time 0 and approximately 4 weeks later), week 4 reported. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 2 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Harriet de Wit | University of Chicago | 773-702-3560 | dewitlab@yoda.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| D000082 | Acetaminophen |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| 1000 mg Acetaminophen | Drug | We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task. |
|
| 4 mg hydromorphone | Drug | We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task. |
|
| dextrose | Drug | We are administering dextrose to healthy volunteers for our placebo group. |
|
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 |
| BG002 | 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. |
| BG003 | Dextrose (Placebo) | Healthy adult volunteers will receive Dextrose (placebo). |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 4 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task. |
| OG002 | 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. 1000 mg Acetaminophen: We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task. |
| OG003 | Dextrose | Healthy adult volunteers will recieve Dextrose (placebo). dextrose: We are administering dextrose to healthy volunteers for our placebo group. |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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 4 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | 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. 1000 mg Acetaminophen: We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG003 | Dextrose | Healthy adult volunteers will recieve Dextrose (placebo). dextrose: We are administering dextrose to healthy volunteers for our placebo group. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |