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In this study, the investigators will examine the effects of buprenorphine, 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. Recently it has been shown that buprenorphine, a partial mu-opioid agonist, reduces sensitivity to recognition of fearful facial expressions in humans. Here, the investigators propose to further explore the role of the opioid system in mediating stress responses in humans through the use of buprenorphine. The investigators hypothesize that buprenorphine with reduce both physiological and subjective measures of stress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | Healthy volunteers receive placebo during session (within-subjects design). |
|
| buprenorphine (0.2 mg) group | Experimental | Healthy volunteers receive buprenorphine (0.2 mg) during session (within-subjects design). |
|
| buprenorphine (0.4 mg) group | Experimental | Healthy volunteers receive buprenorphine (0.4 mg) during session (within-subjects design). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine 0.2 MG Sublingual Tablet | Drug | This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.2) |
| 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 Subjective Responses to Stress With and Without Buprenorphine | 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", 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. | End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shown |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harriet de Wit, Ph.D. | University of Chicago | Principal Investigator |
| Jerome Jaffe, M.D. | University of Maryland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group | Healthy volunteers receive placebo |
| FG001 | 0.2 Buprenorphine | Healthy volunteers will receive 0.2 mg of buprenorphine |
| FG002 | 0.4 mg Buprenorphine | Healthy volunteers will receive 0.4 mg of buprenorphine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group | Healthy volunteers receive placebo during session (within-subjects design). Placebo: This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive a placebo |
| BG001 | Buprenorphine (0.2 mg) Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Subjective Responses to Stress With and Without Buprenorphine | 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", 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. | Posted | Mean | Standard Deviation | units on a scale | End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shown |
|
6 days for each intervention
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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 | Placebo Group | Healthy volunteers receive placebo | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Harriet de Wit | University of Chicago | 7737023560 | dewitlab@yoda.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D000286 | Administration, Sublingual |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive a placebo |
|
| Buprenorphine 0.4 MG Sublingual Tablet | Drug | This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.4) |
|
Healthy volunteers receive buprenorphine (0.2 mg) during session (within-subjects design). Buprenorphine 0.2 MG Sublingual Tablet: This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.2) |
| BG002 | Buprenorphine (0.4 mg) Group | Healthy volunteers receive buprenorphine (0.4 mg) during session (within-subjects design). Buprenorphine 0.4 MG Sublingual Tablet: This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.4) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 0.2 Buprenorphine | Healthy volunteers will receive 0.2 mg of buprenorphine |
| OG002 | 0.4 mg Buprenorphine | Healthy volunteers will receive 0.4 mg of buprenorphine |
|
|
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 0.2 Buprenorphine | Healthy volunteers will receive 0.2 mg of buprenorphine | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | 0.4 mg Buprenorphine | Healthy volunteers will receive 0.4 mg of buprenorphine | 0 | 15 | 0 | 15 | 0 | 15 |
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| 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 |
| D000284 | Administration, Oral |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |