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| ID | Type | Description | Link |
|---|---|---|---|
| 24330 | Other Identifier | Brain & Behavior Research Foundation |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Brain & Behavior Research Foundation | OTHER |
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This is a randomized control trial with an anticipated 36 participants diagnosed with post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Participants will be randomized to receive either progesterone (200 mg. bid) or placebo in identical looking capsules for three days.
One goal of this research study is to test if progesterone is more effective than placebo in reducing craving after exposure to trauma cues and alcohol cues in a laboratory paradigm among men and women with AD and PTSD. We hypothesize that progesterone in comparison to placebo will significantly reduce craving for alcohol in response to trauma cues alone and in combination with alcohol cues in individuals with AD and PTSD.
A second goal is to examine if there are gender differences in progesterone effects on stress and alcohol cue-induced craving. We hypothesize that the effects of progesterone on stress and craving will be stronger in women than in men. Participants will be recruited primarily through advertisement, but also through the clinical facilities at the VA and from other collaborators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progesterone | Experimental | For the three days prior to each test day every participant in this arm will receive one progesterone capsule (200 mg. bid) on the first day and 2 progesterone capsules per day for days 2 and 3. On the test day the participant will receive the last progesterone capsule (200 mg.bid). 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) |
|
| Placebo | Placebo Comparator | For the three days prior to each test day every participant in this arm will receive one placebo capsule on the first day and 2 placebo capsules per day for days 2 and 3. On the test day the participant will receive the last placebo capsule. 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug |
| ||
| Placebo (for Progesterone) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale of Craving (VASC) Baseline no Script | Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol) | Baseline |
| Visual Analogue Scale of Craving (VASC) 10 Minutes (Pre-script #1) | Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol) | 10 minutes |
| Visual Analogue Scale of Craving (VASC) 25 Minutes (Post-Script #1) | Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol) | 25 minutes |
| Visual Analogue Scale of Craving (VASC) 40 Minutes (Post-Recovery #1) | Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol) | 40 minutes |
| Visual Analogue Scale of Craving (VASC) 65 Minutes (Pre-Script #2) | Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol) | 65 minutes |
| Visual Analogue Scale of Craving (VASC) 80 Minutes (Post-Script #2) | Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol) | 80 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| State Trait Anxiety Inventory (STAI-6) Baseline no Script | Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Ralevski, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healtcase System | West Haven | Connecticut | 06516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38147491 | Derived | Ralevski E, Newcomb J, Pisani E, DeNegre D, Peltier M, Jane JS, Yoon G, Petrakis I. Progesterone Attenuates the Stress Response in Individuals with Alcohol Dependence and Post-Traumatic Stress Disorder - A Pilot Study. J Dual Diagn. 2024 Jan-Mar;20(1):39-51. doi: 10.1080/15504263.2023.2294989. Epub 2024 Feb 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Progesterone All Study Participants | For the three days prior to each test day every participant in this arm will receive one progesterone capsule (200 mg. bid) on the first day and 2 progesterone capsules per day for days 2 and 3. On the test day the participant will receive the last progesterone capsule (200 mg.bid). 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) Progesterone |
| FG001 | Placebo All Study Participants | For the three days prior to each test day every participant in this arm will receive one placebo capsule on the first day and 2 placebo capsules per day for days 2 and 3. On the test day the participant will receive the last placebo capsule . 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) Placebo (for Progesterone) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Men and women ages 21 to 60; have current diagnosis of either AUD and comorbid PTSD
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| ID | Title | Description |
|---|---|---|
| BG000 | Progesterone All Study Participants | For the three days prior to each test day every participant in this arm will receive one progesterone capsule (200 mg. bid) on the first day and 2 progesterone capsules per day for days 2 and 3. On the test day the participant will receive the last progesterone capsule (200 mg.bid). 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) Progesterone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analogue Scale of Craving (VASC) Baseline no Script | Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | Baseline |
|
5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Progesterone All Study Participants | For the three days prior to each test day every participant in this arm will receive one progesterone capsule (200 mg. bid) on the first day and 2 progesterone capsules per day for days 2 and 3. On the test day the participant will receive the last progesterone capsule (200 mg.bid). 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) Progesterone |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Ralevski | Yale University School of Medicine, Department of Psychiatry | 203-932-5711 | 4282 | elizabeth.ralevski@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2021 | Sep 7, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Visual Analogue Scale of Craving (VASC) 95 Minutes (Post-Recovery #2) | Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol) | 95 minutes |
| Visual Analogue Scale of Anxiety (VASA) Baseline no Script | Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious) | Baseline |
| Visual Analogue Scale of Anxiety (VASA) 10 Minutes (Pre-Script #1) | Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious) | 10 minutes |
| Visual Analogue Scale of Anxiety (VASA) 25 Minutes (Post-Script #1) | Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious) | 25 minutes |
| Visual Analogue Scale of Anxiety (VASA) 40 Minutes (Post-Recovery #1) | Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious) | 40 minutes |
| Visual Analogue Scale of Anxiety (VASA) 65 Minutes (Pre-Script #2) | Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious) | 65 minutes |
| Visual Analogue Scale of Anxiety (VASA) 80 Minutes (Post-Script #2) | Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious) | 80 minutes |
| Visual Analogue Scale of Anxiety (VASA) 95 Minutes (Post-Recovery #2) | Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious) | 95 minutes |
| Baseline |
| Six-item State-Trait Anxiety Inventory (STAI-6) 10 Minutes (Pre-Script #1) | Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24) | 10 minutes |
| Six-item State-Trait Anxiety Inventory (STAI-6) 25 Minutes (Post-Script #1) | Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24) | 25 minutes |
| Six-item State-Trait Anxiety Inventory (STAI-6) 40 Minutes (Post-Recovery #1) | Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24) | 40 minutes |
| Six-item State-Trait Anxiety Inventory (STAI-6) 65 Minutes (Pre-Script #2) | Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24) | 65 minutes |
| Six-item State-Trait Anxiety Inventory (STAI-6) 80 Minutes (Post-Script #2) | Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24) | 80 minutes |
| Six-item State-Trait Anxiety Inventory (STAI-6) (STAI-6) 95 Minutes (Post-Recovery #2) | Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24) | 95 minutes |
| BG001 | Placebo All Study Participants | For the three days prior to each test day every participant in this arm will receive one placebo capsule on the first day and 2 placebo capsules per day for days 2 and 3. On the test day the participant will receive the last placebo capsule . 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) Placebo (for Progesterone) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | State Trait Anxiety Inventory (STAI-6) Baseline no Script | Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | Baseline |
|
|
|
| Secondary | Six-item State-Trait Anxiety Inventory (STAI-6) 10 Minutes (Pre-Script #1) | Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 10 minutes |
|
|
|
| Secondary | Six-item State-Trait Anxiety Inventory (STAI-6) 25 Minutes (Post-Script #1) | Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 25 minutes |
|
|
|
| Secondary | Six-item State-Trait Anxiety Inventory (STAI-6) 40 Minutes (Post-Recovery #1) | Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 40 minutes |
|
|
|
| Secondary | Six-item State-Trait Anxiety Inventory (STAI-6) 65 Minutes (Pre-Script #2) | Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 65 minutes |
|
|
|
| Secondary | Six-item State-Trait Anxiety Inventory (STAI-6) 80 Minutes (Post-Script #2) | Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 80 minutes |
|
|
|
| Secondary | Six-item State-Trait Anxiety Inventory (STAI-6) (STAI-6) 95 Minutes (Post-Recovery #2) | Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 95 minutes |
|
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|
| Primary | Visual Analogue Scale of Craving (VASC) 10 Minutes (Pre-script #1) | Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 10 minutes |
|
|
|
| Primary | Visual Analogue Scale of Craving (VASC) 25 Minutes (Post-Script #1) | Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 25 minutes |
|
|
|
| Primary | Visual Analogue Scale of Craving (VASC) 40 Minutes (Post-Recovery #1) | Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 40 minutes |
|
|
|
| Primary | Visual Analogue Scale of Craving (VASC) 65 Minutes (Pre-Script #2) | Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 65 minutes |
|
|
|
| Primary | Visual Analogue Scale of Craving (VASC) 80 Minutes (Post-Script #2) | Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 80 minutes |
|
|
|
| Primary | Visual Analogue Scale of Craving (VASC) 95 Minutes (Post-Recovery #2) | Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 95 minutes |
|
|
|
| Primary | Visual Analogue Scale of Anxiety (VASA) Baseline no Script | Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | Baseline |
|
|
|
| Primary | Visual Analogue Scale of Anxiety (VASA) 10 Minutes (Pre-Script #1) | Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 10 minutes |
|
|
|
| Primary | Visual Analogue Scale of Anxiety (VASA) 25 Minutes (Post-Script #1) | Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 25 minutes |
|
|
|
| Primary | Visual Analogue Scale of Anxiety (VASA) 40 Minutes (Post-Recovery #1) | Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 40 minutes |
|
|
|
| Primary | Visual Analogue Scale of Anxiety (VASA) 65 Minutes (Pre-Script #2) | Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 65 minutes |
|
|
|
| Primary | Visual Analogue Scale of Anxiety (VASA) 80 Minutes (Post-Script #2) | Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 80 minutes |
|
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| Primary | Visual Analogue Scale of Anxiety (VASA) 95 Minutes (Post-Recovery #2) | Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious) | All available data was utilized in the analysis using mixed models | Posted | Mean | Standard Error | units on a scale | 95 minutes |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Placebo All Study Participants | For the three days prior to each test day every participant in this arm will receive one placebo capsule on the first day and 2 placebo capsules per day for days 2 and 3. On the test day the participant will receive the last placebo capsule . 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) Placebo (for Progesterone) | 0 | 5 | 0 | 5 | 0 | 5 |
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| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |