Trial Outcomes & Findings for Effect of Allopregnanolone on Stress-induced Craving (NCT NCT04015869)
NCT ID: NCT04015869
Last Updated: 2025-08-22
Results Overview
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).
COMPLETED
PHASE1
10 participants
Pre-Script 40 minutes before trauma/neutral script is presented
2025-08-22
Participant Flow
Participant milestones
| Measure |
Allopregnanolone
On the test day the participant received an allopregnanolone (ALLO) infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
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|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Allopregnanolone on Stress-induced Craving
Baseline characteristics by cohort
| Measure |
Allopregnanolone 100nM
n=5 Participants
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.
|
Placebo
n=5 Participants
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.
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Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
40.8 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
38.1 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-Script 40 minutes before trauma/neutral script is presentedPopulation: All available data was utilized in the analysis using mixed models
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).
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
Alcohol Urge Questionnaire (AUQ) Pre-script
|
24.45 units on a scale
Standard Error 6.18
|
21.51 units on a scale
Standard Error 5.05
|
19.15 units on a scale
Standard Error 6.18
|
26.29 units on a scale
Standard Error 5.05
|
PRIMARY outcome
Timeframe: Pre-Script 40 minutes before trauma/neutral script is presentedPopulation: All available data was utilized in the analysis using mixed models
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)
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Pre-Script
|
1.4 units on a scale
Standard Error 0.26
|
1.0 units on a scale
Standard Error 0.26
|
1.0 units on a scale
Standard Error 0.26
|
1.4 units on a scale
Standard Error 0.26
|
PRIMARY outcome
Timeframe: Post-Script 5 minutes after trauma/neutral script is presentedPopulation: All available data was utilized in the analysis using mixed models
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).
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
Alcohol Urge Questionnaire (AUQ) Post-Script
|
27.09 units on a scale
Standard Error 6.10
|
21.50 units on a scale
Standard Error 7.61
|
14.12 units on a scale
Standard Error 6.63
|
24.70 units on a scale
Standard Error 7.61
|
PRIMARY outcome
Timeframe: Recovery 10 minutes after trauma/neutral script is presentedPopulation: All available data was utilized in the analysis using mixed models
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).
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
Alcohol Urge Questionnaire (AUQ) Recovery
|
25.65 units on a scale
Standard Error 6.56
|
25.76 units on a scale
Standard Error 6.90
|
17.03 units on a scale
Standard Error 7.14
|
24.70 units on a scale
Standard Error 7.61
|
PRIMARY outcome
Timeframe: Post-Script 5 minutes after trauma/neutral script is presentedPopulation: All available data was utilized in the analysis using mixed models
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)
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Post-Script
|
1.6 units on a scale
Standard Error 0.26
|
1.0 units on a scale
Standard Error 0.26
|
1.6 units on a scale
Standard Error 0.26
|
1.4 units on a scale
Standard Error 0.26
|
PRIMARY outcome
Timeframe: Recovery 10 minutes after trauma/neutral script is presentedPopulation: All available data was utilized in the analysis using mixed models
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)
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Recovery
|
1.0 units on a scale
Standard Error 0.26
|
1.0 units on a scale
Standard Error 0.26
|
1.4 units on a scale
Standard Error 0.26
|
1.2 units on a scale
Standard Error 0.26
|
PRIMARY outcome
Timeframe: Pre-Script 40 minutes before trauma/neutral script is presentedPopulation: All available data was utilized in the analysis using mixed models
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)
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Pre-Script
|
3.16 units on a scale
Standard Error 0.41
|
3.6 units on a scale
Standard Error 0.39
|
3.0 units on a scale
Standard Error 0.39
|
2.2 units on a scale
Standard Error 0.39
|
PRIMARY outcome
Timeframe: Post-Script 5 minutes after trauma/neutral script is presentedPopulation: All available data was utilized in the analysis using mixed models
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)
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Post-Script
|
2.2 units on a scale
Standard Error 0.39
|
3.6 units on a scale
Standard Error 0.39
|
2.8 units on a scale
Standard Error 0.39
|
2.8 units on a scale
Standard Error 0.39
|
PRIMARY outcome
Timeframe: Recovery10 minutes after trauma/neutral script is presentedPopulation: All available data was utilized in the analysis using mixed models
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)
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Recovery
|
3.2 units on a scale
Standard Error 0.39
|
3.4 units on a scale
Standard Error 0.39
|
2.4 units on a scale
Standard Error 0.39
|
2.2 units on a scale
Standard Error 0.39
|
PRIMARY outcome
Timeframe: Pre-Script 40 minutes before trauma/neutral script is presentedPopulation: All available data was utilized in the analysis using mixed models
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)
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
The State-Trait Anxiety Inventory (STAI-6) I am Worried - Pre-Script
|
1.0 units on a scale
Standard Error 0.23
|
1.0 units on a scale
Standard Error 0.23
|
1.2 units on a scale
Standard Error 0.23
|
1.6 units on a scale
Standard Error 0.23
|
PRIMARY outcome
Timeframe: Post-Script 5 minutes after trauma/neutral script is presentedPopulation: All available data was utilized in the analysis using mixed models
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)
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
The State-Trait Anxiety Inventory (STAI-6) I am Worried - Post-Script
|
1.6 units on a scale
Standard Error 0.23
|
1.0 units on a scale
Standard Error 0.23
|
1.4 units on a scale
Standard Error 0.23
|
1.4 units on a scale
Standard Error 0.23
|
PRIMARY outcome
Timeframe: Recovery 10 minutes after trauma/neutral script is presentedPopulation: All available data was utilized in the analysis using mixed models
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)
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
The State-Trait Anxiety Inventory (STAI-6) I am Worried - Recovery
|
1.0 units on a scale
Standard Error 0.23
|
1.0 units on a scale
Standard Error 0.23
|
1.2 units on a scale
Standard Error 0.23
|
1.2 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Pre-Script 40 minutes before trauma/neutral script is presentedPopulation: Analysis Population Description: All available data was utilized in the analysis using mixed models
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.
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) Sedation Items - Pre-Script
|
6.4 units on a scale
Standard Error 2.71
|
6.2 units on a scale
Standard Error 2.71
|
—
|
—
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) Sedation Items
|
10.6 units on a scale
Standard Error 3.38
|
5.2 units on a scale
Standard Error 3.38
|
—
|
—
|
SECONDARY outcome
Timeframe: Target Alcohol dose (40mg%) 90 minutes after trauma/neutral script is presentedPopulation: Analysis Population Description: All available data was utilized in the analysis using mixed models
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.
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) Sedation Items - Target Alcohol Dose (40mg%)
|
5.8 units on a scale
Standard Error 3.72
|
4.2 units on a scale
Standard Error 3.72
|
—
|
—
|
SECONDARY outcome
Timeframe: End of test day 150 minutes after trauma/neutral script is presentedPopulation: All available data was utilized in the analysis using mixed models
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.
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) Sedation Items - End of Test Day
|
2.8 units on a scale
Standard Error 2.54
|
6.4 units on a scale
Standard Error 2.54
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-Script 40 minutes before trauma/neutral script is presentedPopulation: Analysis Population Description: All available data was utilized in the analysis using mixed models
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.
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Pre-Script
|
25.8 units on a scale
Standard Error 6.8
|
14.2 units on a scale
Standard Error 6.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) Stimulation Items
|
17.4 units on a scale
Standard Error 8.18
|
15.6 units on a scale
Standard Error 8.18
|
—
|
—
|
SECONDARY outcome
Timeframe: Target Alcohol Dose (40mg%) 90 minutes after trauma/neutral script is presentedPopulation: Analysis Population Description: All available data was utilized in the analysis using mixed models
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.
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Target Alcohol Dose (40mg%)
|
26.2 units on a scale
Standard Error 5.36
|
31.4 units on a scale
Standard Error 5.36
|
—
|
—
|
SECONDARY outcome
Timeframe: End of Test Day 150 minutes after trauma/neutral script is presentedPopulation: Analysis Population Description: All available data was utilized in the analysis using mixed models
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.
Outcome measures
| Measure |
Allopregnanolone Trauma Script
n=5 Participants
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Allopregnanolone Neutral Script
n=5 Participants
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Trauma Script
On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
Placebo Neutral Script
On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.
|
|---|---|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) Stimulation Items - End of Test Day
|
17.6 units on a scale
Standard Error 4.18
|
17.4 units on a scale
Standard Error 4.18
|
—
|
—
|
Adverse Events
Allopregnanolone
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elizabeth Ralevski
Yale University School of Medicine, Department of Psychiatry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place