Progesterone Effect on Individuals Diagnoses With AD and PTSD.

Study Overview
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Brief Summary
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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.

Official Title
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Progesterone Treatment in Reducing Trauma and Alcohol Induced Craving in Individuals Diagnoses With Alcohol Dependence (AD) and Post-tramatic Stress Disorder (PTSD).

Conditions
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Alcohol Dependence, Post-Traumatic Stress Disorder (PTSD)

Intervention / Treatment
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* Drug: Progesterone
* Drug: Placebo (for Progesterone)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women ages 21 to 60; Current diagnosis of AD and PTSD; Drink regularly are not in an active phase of alcohol withdrawal; Not at risk for suicide; Not taking regularly psychoactive drugs including anxiolytics and antidepressants; For women, have regular menses every 25-35 days. Exclusion Criteria: Current SCID diagnosis of any psychotic disorder; Substance dependence (other than alcohol and nicotine) in the past 30 days; Current unstable medical condition; Positive test results at more than one baseline appointment on urine drug screens conducted for opiates, cocaine, marijuana, benzodiazepines, and barbiturates; for women, amenorrhea, use of oral contraceptives; Known allergy to progesterone or peanuts (vehicle for micronized progesterone); History of thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or Bleeding disorders, heart disease, diabetes or history of stroke.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progesterone<br>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) | Drug: Progesterone<br> <br> |
| Placebo Comparator: Placebo<br>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) | Drug: Placebo (for Progesterone)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Dependence, Post-Traumatic stress disorder (PTSD), Progesterone