Basic Science
Conditions
Keywords
opioid, subjective, stress, buprenorphine
Brief summary
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.
Interventions
DRUGBuprenorphine 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)
DRUGPlacebo
This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive a placebo
DRUGBuprenorphine 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)
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men and women * ages 18-40 years * high school education * fluent in English
Exclusion criteria
* history of adverse drug reactions * taking oral contraceptives or planning to become pregnant * taking any medications * smokers * night shift workers * drink more than 4 alcoholic or caffeinated drinks per day
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 Subjective Responses to Stress With and Without Buprenorphine | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| Buprenorphine (0.2 mg) Group 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) | 15 |
| 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) | 15 |
| Total | 48 |
Baseline characteristics
| Characteristic | Placebo Group | Buprenorphine (0.2 mg) Group | Buprenorphine (0.4 mg) Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 15 Participants | 15 Participants | 48 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Male | 12 Participants | 9 Participants | 11 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 18 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 18 | 0 / 15 | 0 / 15 |
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 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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Group | 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 | Like Drug | 9.4 units on a scale | Standard Deviation 1.2 |
| Placebo Group | 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 | Feel Drug | 13.57 units on a scale | Standard Deviation 2.1 |
| Placebo Group | 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 | Feel High | 6.0 units on a scale | Standard Deviation 1.5 |
| Placebo Group | 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 | Want More | 4.27 units on a scale | Standard Deviation 1.3 |
| 0.2 Buprenorphine | 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 | Want More | 12.47 units on a scale | Standard Deviation 1.9 |
| 0.2 Buprenorphine | 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 | Feel High | 27.27 units on a scale | Standard Deviation 2.5 |
| 0.2 Buprenorphine | 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 | Feel Drug | 36.57 units on a scale | Standard Deviation 4.5 |
| 0.2 Buprenorphine | 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 | Like Drug | 43.27 units on a scale | Standard Deviation 3.6 |
| 0.4 mg Buprenorphine | 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 | Feel Drug | 59.89 units on a scale | Standard Deviation 1.55 |
| 0.4 mg Buprenorphine | 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 | Like Drug | 56.25 units on a scale | Standard Deviation 4.22 |
| 0.4 mg Buprenorphine | 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 | Feel High | 41.69 units on a scale | Standard Deviation 3.45 |
| 0.4 mg Buprenorphine | 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 | Want More | 21.57 units on a scale | Standard Deviation 1.96 |