Progesterone Effect on Individuals Diagnoses With AD and PTSD.

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187224
• Other study ID #: 1603017361
• Secondary ID: 24330
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 1, 2016
• Est. completion date: September 8, 2021

Study information

• Verified date: April 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 8, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Men and women ages 21 to 60;

2. Current diagnosis of AD and PTSD;

3. Drink regularly are not in an active phase of alcohol withdrawal;

4. Not at risk for suicide;

5. Not taking regularly psychoactive drugs including anxiolytics and antidepressants;

6. For women, have regular menses every 25-35 days.

Exclusion Criteria:

1. Current SCID diagnosis of any psychotic disorder;

2. Substance dependence (other than alcohol and nicotine) in the past 30 days;

3. Current unstable medical condition;

4. 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;

5. Known allergy to progesterone or peanuts (vehicle for micronized progesterone);

6. History of thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or Bleeding disorders, heart disease, diabetes or history of stroke.

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Post-Traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Progesterone

• Placebo (for Progesterone)

Locations

Country	Name	City	State
United States	VA Connecticut Healtcase System	West Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Brain & Behavior Research Foundation, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Baseline
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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	80 minutes
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)	95 minutes
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)	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)	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)	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)	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)	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)	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)	95 minutes