Healthy
Conditions
Keywords
enrolling, adult, volunteers
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.
Interventions
DRUG2 mg hydromorphone
We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.
We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.
DRUG4 mg hydromorphone
We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.
DRUGdextrose
We are administering dextrose to healthy volunteers for our placebo group.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 4 mg Hydromorphone 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 | 12 |
| 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. | 13 |
| Dextrose (Placebo) Healthy adult volunteers will receive Dextrose (placebo). | 13 |
| Total | 50 |
Baseline characteristics
| Characteristic | 2 mg Hydromophone | 4 mg Hydromorphone | 1000 mg Acetaminophen | Dextrose (Placebo) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 19.9 years STANDARD_DEVIATION 1.8 | 21.2 years STANDARD_DEVIATION 2.8 | 23.6 years STANDARD_DEVIATION 6.6 | 23.1 years STANDARD_DEVIATION 4.4 | 22 years STANDARD_DEVIATION 4.5 |
| Region of Enrollment United States | 12 participants | 12 participants | 13 participants | 13 participants | 50 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 6 Participants | 5 Participants | 19 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 7 Participants | 8 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 13 | 0 / 13 |
Outcome results
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
Time frame: End of study (time 0 and approximately 4 weeks later), week 4 reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2 mg Hydromophone | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel Drug | 7.41 units on a scale | Standard Deviation 1.2 |
| 2 mg Hydromophone | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Like Drug | 25.9 units on a scale | Standard Deviation 1.8 |
| 2 mg Hydromophone | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel High | 6.08 units on a scale | Standard Deviation 1.5 |
| 2 mg Hydromophone | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Want More | 8.0 units on a scale | Standard Deviation 2.1 |
| 4 mg Hydromphone | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Like Drug | 35.58 units on a scale | Standard Deviation 2.5 |
| 4 mg Hydromphone | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel High | 10.33 units on a scale | Standard Deviation 1.01 |
| 4 mg Hydromphone | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Want More | 26.83 units on a scale | Standard Deviation 1.5 |
| 4 mg Hydromphone | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel Drug | 14.75 units on a scale | Standard Deviation 1.9 |
| 1000 mg Acetaminophen | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel High | 15 units on a scale | Standard Deviation 1.8 |
| 1000 mg Acetaminophen | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Like Drug | 9.61 units on a scale | Standard Deviation 2.2 |
| 1000 mg Acetaminophen | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Want More | 7.38 units on a scale | Standard Deviation 1.96 |
| 1000 mg Acetaminophen | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel Drug | 28 units on a scale | Standard Deviation 1.5 |
| Dextrose | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Want More | 2.65 units on a scale | Standard Deviation 1.5 |
| Dextrose | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Like Drug | 4.15 units on a scale | Standard Deviation 1.4 |
| Dextrose | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel Drug | 5.76 units on a scale | Standard Deviation 1.1 |
| Dextrose | Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire | Feel High | 2.61 units on a scale | Standard Deviation 1.8 |