Alcohol Use Disorder
Conditions
Brief summary
The goal of this study is to determine whether intravenous infusion of allopregnanolone (ALLO) attenuates stress-induced craving and stress-induced anxiety in a clinical laboratory setting. The secondary objective of this project is to characterize the behavioral effects of ALLO in heavy drinkers.
Detailed description
This is a double-blind, placebo-controlled study that will randomize heavy at risk drinkers to 2 groups: targeted dose of 100 nM of ALLO or placebo. Participants will receive a continuous infusion of ALLO (or placebo) for approximately 175 min. Sixty minutes after the start of the infusion, when ALLO levels are relatively stable, the stress induction paradigm will be introduced. Participants will be presented with a stress cue and a neutral cue in random order. Stress and neutral cues will consist of personalized 5-minute scripts created prior to testing. Measures of stress-induced craving and stress-induced anxiety will be presented before the cue (pre), immediately following the cue (post) and 10 minutes after (recovery). An alcohol infusion (40mg%) begins at approximately 120 minutes into ALLO Infusion. Once the alcohol infusion has reached the targeted dose of 40mg% the infusion is clamped for approximately 20 minutes. The study outcomes will include measures of stress-induced craving and stress-induced anxiety as well as measures of subjective mood effects, cognitive performance, and motor coordination.
Interventions
DRUGAllopregnanolone
neurosteroid
DRUGPlacebos
placebo
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double blind, placebo controlled
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Non-treatment seeking individuals with current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) alcohol use disorder (AUD) * No current substance use disorder (except tobacco, alcohol, and marijuana) * No current medical problems and normal electrocardiogram (ECG) * For women, not pregnant as determined by pregnancy screening, not breast feeding.
Exclusion criteria
* Current major psychiatric illnesses including mood, psychotic, or anxiety disorders * History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study * Liver function tests (ALT or AST) greater than 3 times normal * weight \>120kg * renal impairment * patients on the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation (please note patients on psychotropic medications for current psychiatric conditions will also be excluded); and c) patients currently taking antibiotics or antifungals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The State-Trait Anxiety Inventory (STAI-6) I am Worried - Recovery | Recovery 10 minutes after trauma/neutral script is presented | The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 6. I am worried (scored individually): the scoring for I feel content is: a = 1, b = 2, c = 3, and d = 4 (1 not at all worried to 4 very much worried) |
| Alcohol Urge Questionnaire (AUQ) Recovery | Recovery 10 minutes after trauma/neutral script is presented | The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Total scores range from 8 (strongly disagree) to 56 (strongly agree). |
| The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Post-Script | Post-Script 5 minutes after trauma/neutral script is presented | The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 3. I feel upset (scored individually): the scoring for I feel upset is: a = 1, b = 2, c = 3, and d = 4 (1 not at all upset to 4 very much upset) |
| The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Recovery | Recovery 10 minutes after trauma/neutral script is presented | The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 3. I feel upset (scored individually): the scoring for I feel upset is: a = 1, b = 2, c = 3, and d = 4 (1 not at all upset to 4 very much upset) |
| The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Pre-Script | Pre-Script 40 minutes before trauma/neutral script is presented | The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 5. I feel content (scored individually): the scoring for I feel content is: a = 4, b = 3, c = 2, and d = 1 (4 not at all content to 1 very much content) |
| The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Post-Script | Post-Script 5 minutes after trauma/neutral script is presented | The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 5. I feel content (scored individually): the scoring for I feel content is: a = 4, b = 3, c = 2, and d = 1 (4 not at all content to 1 very much content) |
| The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Recovery | Recovery10 minutes after trauma/neutral script is presented | The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 5. I feel content (scored individually): the scoring for I feel content is: a = 4, b = 3, c = 2, and d = 1 (4 not at all content to 1 very much content) |
| The State-Trait Anxiety Inventory (STAI-6) I am Worried - Pre-Script | Pre-Script 40 minutes before trauma/neutral script is presented | The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 6. I am worried (scored individually): the scoring for I feel content is: a = 1, b = 2, c = 3, and d = 4 (1 not at all worried to 4 very much worried) |
| The State-Trait Anxiety Inventory (STAI-6) I am Worried - Post-Script | Post-Script 5 minutes after trauma/neutral script is presented | The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 6. I am worried (scored individually): the scoring for I feel content is: a = 1, b = 2, c = 3, and d = 4 (1 not at all worried to 4 very much worried) |
| Alcohol Urge Questionnaire (AUQ) Pre-script | Pre-Script 40 minutes before trauma/neutral script is presented | The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Total scores range from 8 (strongly disagree) to 56 (strongly agree). |
| The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Pre-Script | Pre-Script 40 minutes before trauma/neutral script is presented | The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 3. I feel upset (scored individually): the scoring for I feel upset is: a = 1, b = 2, c = 3, and d = 4 (1 not at all upset to 4 very much upset) |
| Alcohol Urge Questionnaire (AUQ) Post-Script | Post-Script 5 minutes after trauma/neutral script is presented | The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Total scores range from 8 (strongly disagree) to 56 (strongly agree). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biphasic Alcohol Effects Scale (BAES) Sedation Items | Pre-infusion (at 0 minutes), during infusion (approximately 20 minutes) and post-infusion (approximately 90 minutes) | Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol. Data presented here is mean at 90 minutes. |
| Biphasic Alcohol Effects Scale (BAES) Sedation Items - Target Alcohol Dose (40mg%) | Target Alcohol dose (40mg%) 90 minutes after trauma/neutral script is presented | Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol. |
| Biphasic Alcohol Effects Scale (BAES) Sedation Items - End of Test Day | End of test day 150 minutes after trauma/neutral script is presented | Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol. |
| Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Pre-Script | Pre-Script 40 minutes before trauma/neutral script is presented | Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol. |
| Biphasic Alcohol Effects Scale (BAES) Stimulation Items | Pre-infusion (at 0 minutes), during infusion (approximately 20 minutes) and post-infusion (approximately 90 minutes) | Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol. Data presented here is mean at 90 minutes. |
| Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Target Alcohol Dose (40mg%) | Target Alcohol Dose (40mg%) 90 minutes after trauma/neutral script is presented | Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol. |
| Biphasic Alcohol Effects Scale (BAES) Stimulation Items - End of Test Day | End of Test Day 150 minutes after trauma/neutral script is presented | Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol. |
| Biphasic Alcohol Effects Scale (BAES) Sedation Items - Pre-Script | Pre-Script 40 minutes before trauma/neutral script is presented | Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Allopregnanolone 100nM Targeted dose of 100 nM of ALLO, a continuous infusion of ALLO for approximately 175 min. Sixty minutes after the start of the infusion, when ALLO levels are relatively stable, the stress induction paradigm will be introduced. Stress and neutral cues will consist of personalized 5-minute scripts created prior to testing. Measures of stress-induced craving and stress-induced anxiety will be presented before the cue (pre), immediately following the cue (post) and 10 minutes after (recovery). An alcohol infusion (40mg%) begins at approximately 120 minutes into ALLO Infusion. Once the alcohol infusion has reached the targeted dose of 40mg% the infusion is clamped for approximately 20 minutes. After 20-minute clamp both infusions will end. | 5 |
| Placebo Placebo dose, a continuous infusion of placebo for approximately 175 min. Sixty minutes after the start of the infusion, when ALLO levels are relatively stable, the stress induction paradigm will be introduced. Stress and neutral cues will consist of personalized 5-minute scripts created prior to testing. Measures of stress-induced craving and stress-induced anxiety will be presented before the cue (pre), immediately following the cue (post) and 10 minutes after (recovery). An alcohol infusion (40mg%) begins at approximately 120 minutes into ALLO Infusion. Once the alcohol infusion has reached the targeted dose of 40mg% the infusion is clamped for approximately 20 minutes. After 20-minute clamp both infusions will end. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Total | Allopregnanolone 100nM | Placebo |
|---|---|---|---|
| Age, Continuous | 38.1 years STANDARD_DEVIATION 9.1 | 35.4 years STANDARD_DEVIATION 10.8 | 40.8 years STANDARD_DEVIATION 7.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 8 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Alcohol Urge Questionnaire (AUQ) Post-Script
The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Total scores range from 8 (strongly disagree) to 56 (strongly agree).
Time frame: Post-Script 5 minutes after trauma/neutral script is presented
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | Alcohol Urge Questionnaire (AUQ) Post-Script | 27.09 units on a scale | Standard Error 6.1 |
| Allopregnanolone Neutral Script | Alcohol Urge Questionnaire (AUQ) Post-Script | 21.50 units on a scale | Standard Error 7.61 |
| Placebo Trauma Script | Alcohol Urge Questionnaire (AUQ) Post-Script | 14.12 units on a scale | Standard Error 6.63 |
| Placebo Neutral Script | Alcohol Urge Questionnaire (AUQ) Post-Script | 24.70 units on a scale | Standard Error 7.61 |
Primary
Alcohol Urge Questionnaire (AUQ) Pre-script
The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Total scores range from 8 (strongly disagree) to 56 (strongly agree).
Time frame: Pre-Script 40 minutes before trauma/neutral script is presented
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | Alcohol Urge Questionnaire (AUQ) Pre-script | 24.45 units on a scale | Standard Error 6.18 |
| Allopregnanolone Neutral Script | Alcohol Urge Questionnaire (AUQ) Pre-script | 21.51 units on a scale | Standard Error 5.05 |
| Placebo Trauma Script | Alcohol Urge Questionnaire (AUQ) Pre-script | 19.15 units on a scale | Standard Error 6.18 |
| Placebo Neutral Script | Alcohol Urge Questionnaire (AUQ) Pre-script | 26.29 units on a scale | Standard Error 5.05 |
Primary
Alcohol Urge Questionnaire (AUQ) Recovery
The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Total scores range from 8 (strongly disagree) to 56 (strongly agree).
Time frame: Recovery 10 minutes after trauma/neutral script is presented
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | Alcohol Urge Questionnaire (AUQ) Recovery | 25.65 units on a scale | Standard Error 6.56 |
| Allopregnanolone Neutral Script | Alcohol Urge Questionnaire (AUQ) Recovery | 25.76 units on a scale | Standard Error 6.9 |
| Placebo Trauma Script | Alcohol Urge Questionnaire (AUQ) Recovery | 17.03 units on a scale | Standard Error 7.14 |
| Placebo Neutral Script | Alcohol Urge Questionnaire (AUQ) Recovery | 24.70 units on a scale | Standard Error 7.61 |
Primary
The State-Trait Anxiety Inventory (STAI-6) I am Worried - Post-Script
The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 6. I am worried (scored individually): the scoring for I feel content is: a = 1, b = 2, c = 3, and d = 4 (1 not at all worried to 4 very much worried)
Time frame: Post-Script 5 minutes after trauma/neutral script is presented
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I am Worried - Post-Script | 1.6 units on a scale | Standard Error 0.23 |
| Allopregnanolone Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I am Worried - Post-Script | 1.0 units on a scale | Standard Error 0.23 |
| Placebo Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I am Worried - Post-Script | 1.4 units on a scale | Standard Error 0.23 |
| Placebo Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I am Worried - Post-Script | 1.4 units on a scale | Standard Error 0.23 |
Primary
The State-Trait Anxiety Inventory (STAI-6) I am Worried - Pre-Script
The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 6. I am worried (scored individually): the scoring for I feel content is: a = 1, b = 2, c = 3, and d = 4 (1 not at all worried to 4 very much worried)
Time frame: Pre-Script 40 minutes before trauma/neutral script is presented
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I am Worried - Pre-Script | 1.0 units on a scale | Standard Error 0.23 |
| Allopregnanolone Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I am Worried - Pre-Script | 1.0 units on a scale | Standard Error 0.23 |
| Placebo Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I am Worried - Pre-Script | 1.2 units on a scale | Standard Error 0.23 |
| Placebo Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I am Worried - Pre-Script | 1.6 units on a scale | Standard Error 0.23 |
Primary
The State-Trait Anxiety Inventory (STAI-6) I am Worried - Recovery
The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 6. I am worried (scored individually): the scoring for I feel content is: a = 1, b = 2, c = 3, and d = 4 (1 not at all worried to 4 very much worried)
Time frame: Recovery 10 minutes after trauma/neutral script is presented
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I am Worried - Recovery | 1.0 units on a scale | Standard Error 0.23 |
| Allopregnanolone Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I am Worried - Recovery | 1.0 units on a scale | Standard Error 0.23 |
| Placebo Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I am Worried - Recovery | 1.2 units on a scale | Standard Error 0.23 |
| Placebo Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I am Worried - Recovery | 1.2 units on a scale | Standard Error 0.23 |
Primary
The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Post-Script
The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 5. I feel content (scored individually): the scoring for I feel content is: a = 4, b = 3, c = 2, and d = 1 (4 not at all content to 1 very much content)
Time frame: Post-Script 5 minutes after trauma/neutral script is presented
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Post-Script | 2.2 units on a scale | Standard Error 0.39 |
| Allopregnanolone Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Post-Script | 3.6 units on a scale | Standard Error 0.39 |
| Placebo Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Post-Script | 2.8 units on a scale | Standard Error 0.39 |
| Placebo Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Post-Script | 2.8 units on a scale | Standard Error 0.39 |
Primary
The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Pre-Script
The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 5. I feel content (scored individually): the scoring for I feel content is: a = 4, b = 3, c = 2, and d = 1 (4 not at all content to 1 very much content)
Time frame: Pre-Script 40 minutes before trauma/neutral script is presented
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Pre-Script | 3.16 units on a scale | Standard Error 0.41 |
| Allopregnanolone Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Pre-Script | 3.6 units on a scale | Standard Error 0.39 |
| Placebo Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Pre-Script | 3.0 units on a scale | Standard Error 0.39 |
| Placebo Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Pre-Script | 2.2 units on a scale | Standard Error 0.39 |
Primary
The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Recovery
The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 5. I feel content (scored individually): the scoring for I feel content is: a = 4, b = 3, c = 2, and d = 1 (4 not at all content to 1 very much content)
Time frame: Recovery10 minutes after trauma/neutral script is presented
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Recovery | 3.2 units on a scale | Standard Error 0.39 |
| Allopregnanolone Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Recovery | 3.4 units on a scale | Standard Error 0.39 |
| Placebo Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Recovery | 2.4 units on a scale | Standard Error 0.39 |
| Placebo Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Recovery | 2.2 units on a scale | Standard Error 0.39 |
Primary
The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Post-Script
The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 3. I feel upset (scored individually): the scoring for I feel upset is: a = 1, b = 2, c = 3, and d = 4 (1 not at all upset to 4 very much upset)
Time frame: Post-Script 5 minutes after trauma/neutral script is presented
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Post-Script | 1.6 units on a scale | Standard Error 0.26 |
| Allopregnanolone Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Post-Script | 1.0 units on a scale | Standard Error 0.26 |
| Placebo Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Post-Script | 1.6 units on a scale | Standard Error 0.26 |
| Placebo Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Post-Script | 1.4 units on a scale | Standard Error 0.26 |
Primary
The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Pre-Script
The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 3. I feel upset (scored individually): the scoring for I feel upset is: a = 1, b = 2, c = 3, and d = 4 (1 not at all upset to 4 very much upset)
Time frame: Pre-Script 40 minutes before trauma/neutral script is presented
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Pre-Script | 1.4 units on a scale | Standard Error 0.26 |
| Allopregnanolone Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Pre-Script | 1.0 units on a scale | Standard Error 0.26 |
| Placebo Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Pre-Script | 1.0 units on a scale | Standard Error 0.26 |
| Placebo Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Pre-Script | 1.4 units on a scale | Standard Error 0.26 |
Primary
The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Recovery
The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. I feel calm; 2. I am tense; 3. I feel upset; 4. I am relaxed; 5. I feel content; 6. I am worried. Each of these questions were rated as: a) not at all; b) somewhat; c) moderately; d) very much. For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 3. I feel upset (scored individually): the scoring for I feel upset is: a = 1, b = 2, c = 3, and d = 4 (1 not at all upset to 4 very much upset)
Time frame: Recovery 10 minutes after trauma/neutral script is presented
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Recovery | 1.0 units on a scale | Standard Error 0.26 |
| Allopregnanolone Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Recovery | 1.0 units on a scale | Standard Error 0.26 |
| Placebo Trauma Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Recovery | 1.4 units on a scale | Standard Error 0.26 |
| Placebo Neutral Script | The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Recovery | 1.2 units on a scale | Standard Error 0.26 |
Secondary
Biphasic Alcohol Effects Scale (BAES) Sedation Items
Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol. Data presented here is mean at 90 minutes.
Time frame: Pre-infusion (at 0 minutes), during infusion (approximately 20 minutes) and post-infusion (approximately 90 minutes)
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | Biphasic Alcohol Effects Scale (BAES) Sedation Items | 10.6 units on a scale | Standard Error 3.38 |
| Allopregnanolone Neutral Script | Biphasic Alcohol Effects Scale (BAES) Sedation Items | 5.2 units on a scale | Standard Error 3.38 |
Secondary
Biphasic Alcohol Effects Scale (BAES) Sedation Items - End of Test Day
Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol.
Time frame: End of test day 150 minutes after trauma/neutral script is presented
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | Biphasic Alcohol Effects Scale (BAES) Sedation Items - End of Test Day | 2.8 units on a scale | Standard Error 2.54 |
| Allopregnanolone Neutral Script | Biphasic Alcohol Effects Scale (BAES) Sedation Items - End of Test Day | 6.4 units on a scale | Standard Error 2.54 |
Secondary
Biphasic Alcohol Effects Scale (BAES) Sedation Items - Pre-Script
Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol.
Time frame: Pre-Script 40 minutes before trauma/neutral script is presented
Population: Analysis Population Description: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | Biphasic Alcohol Effects Scale (BAES) Sedation Items - Pre-Script | 6.4 units on a scale | Standard Error 2.71 |
| Allopregnanolone Neutral Script | Biphasic Alcohol Effects Scale (BAES) Sedation Items - Pre-Script | 6.2 units on a scale | Standard Error 2.71 |
Secondary
Biphasic Alcohol Effects Scale (BAES) Sedation Items - Target Alcohol Dose (40mg%)
Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol.
Time frame: Target Alcohol dose (40mg%) 90 minutes after trauma/neutral script is presented
Population: Analysis Population Description: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | Biphasic Alcohol Effects Scale (BAES) Sedation Items - Target Alcohol Dose (40mg%) | 5.8 units on a scale | Standard Error 3.72 |
| Allopregnanolone Neutral Script | Biphasic Alcohol Effects Scale (BAES) Sedation Items - Target Alcohol Dose (40mg%) | 4.2 units on a scale | Standard Error 3.72 |
Secondary
Biphasic Alcohol Effects Scale (BAES) Stimulation Items
Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol. Data presented here is mean at 90 minutes.
Time frame: Pre-infusion (at 0 minutes), during infusion (approximately 20 minutes) and post-infusion (approximately 90 minutes)
Population: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | Biphasic Alcohol Effects Scale (BAES) Stimulation Items | 17.4 units on a scale | Standard Error 8.18 |
| Allopregnanolone Neutral Script | Biphasic Alcohol Effects Scale (BAES) Stimulation Items | 15.6 units on a scale | Standard Error 8.18 |
Secondary
Biphasic Alcohol Effects Scale (BAES) Stimulation Items - End of Test Day
Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol.
Time frame: End of Test Day 150 minutes after trauma/neutral script is presented
Population: Analysis Population Description: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | Biphasic Alcohol Effects Scale (BAES) Stimulation Items - End of Test Day | 17.6 units on a scale | Standard Error 4.18 |
| Allopregnanolone Neutral Script | Biphasic Alcohol Effects Scale (BAES) Stimulation Items - End of Test Day | 17.4 units on a scale | Standard Error 4.18 |
Secondary
Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Pre-Script
Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol.
Time frame: Pre-Script 40 minutes before trauma/neutral script is presented
Population: Analysis Population Description: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Pre-Script | 25.8 units on a scale | Standard Error 6.8 |
| Allopregnanolone Neutral Script | Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Pre-Script | 14.2 units on a scale | Standard Error 6.8 |
Secondary
Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Target Alcohol Dose (40mg%)
Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol.
Time frame: Target Alcohol Dose (40mg%) 90 minutes after trauma/neutral script is presented
Population: Analysis Population Description: All available data was utilized in the analysis using mixed models
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allopregnanolone Trauma Script | Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Target Alcohol Dose (40mg%) | 26.2 units on a scale | Standard Error 5.36 |
| Allopregnanolone Neutral Script | Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Target Alcohol Dose (40mg%) | 31.4 units on a scale | Standard Error 5.36 |