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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
13
VA Connecticut Healtcase System
West Haven, Connecticut, United States
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 95 minutes
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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Time frame: 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)
Time frame: 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)
Time frame: 95 minutes