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Completed

NCT Number: NCT02187224

Progesterone Effect on Individuals Diagnoses With AD and PTSD.

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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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Post-traumatic Stress Disorder (PTSD) Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

VA Connecticut Healtcase System

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Progesterone

Drug

Placebo (for Progesterone)

Drug

Primary outcomes

  1. Visual Analogue Scale of Craving (VASC) Baseline no Script

    Time frame: Baseline

    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)

  2. Visual Analogue Scale of Craving (VASC) 10 Minutes (Pre-script #1)

    Time frame: 10 minutes

    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)

  3. Visual Analogue Scale of Craving (VASC) 25 Minutes (Post-Script #1)

    Time frame: 25 minutes

    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)

  4. Visual Analogue Scale of Craving (VASC) 40 Minutes (Post-Recovery #1)

    Time frame: 40 minutes

    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)

  5. Visual Analogue Scale of Craving (VASC) 65 Minutes (Pre-Script #2)

    Time frame: 65 minutes

    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)

  6. Visual Analogue Scale of Craving (VASC) 80 Minutes (Post-Script #2)

    Time frame: 80 minutes

    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)

  7. Visual Analogue Scale of Craving (VASC) 95 Minutes (Post-Recovery #2)

    Time frame: 95 minutes

    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)

  8. Visual Analogue Scale of Anxiety (VASA) Baseline no Script

    Time frame: Baseline

    Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

  9. Visual Analogue Scale of Anxiety (VASA) 10 Minutes (Pre-Script #1)

    Time frame: 10 minutes

    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. Visual Analogue Scale of Anxiety (VASA) 25 Minutes (Post-Script #1)

    Time frame: 25 minutes

    Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

  11. Visual Analogue Scale of Anxiety (VASA) 40 Minutes (Post-Recovery #1)

    Time frame: 40 minutes

    Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

  12. Visual Analogue Scale of Anxiety (VASA) 65 Minutes (Pre-Script #2)

    Time frame: 65 minutes

    Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

  13. Visual Analogue Scale of Anxiety (VASA) 80 Minutes (Post-Script #2)

    Time frame: 80 minutes

    Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

  14. Visual Analogue Scale of Anxiety (VASA) 95 Minutes (Post-Recovery #2)

    Time frame: 95 minutes

    Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

Secondary outcomes

  1. State Trait Anxiety Inventory (STAI-6) Baseline no Script

    Time frame: Baseline

    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)

  2. Six-item State-Trait Anxiety Inventory (STAI-6) 10 Minutes (Pre-Script #1)

    Time frame: 10 minutes

    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)

  3. Six-item State-Trait Anxiety Inventory (STAI-6) 25 Minutes (Post-Script #1)

    Time frame: 25 minutes

    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)

  4. Six-item State-Trait Anxiety Inventory (STAI-6) 40 Minutes (Post-Recovery #1)

    Time frame: 40 minutes

    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)

  5. Six-item State-Trait Anxiety Inventory (STAI-6) 65 Minutes (Pre-Script #2)

    Time frame: 65 minutes

    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)

  6. Six-item State-Trait Anxiety Inventory (STAI-6) 80 Minutes (Post-Script #2)

    Time frame: 80 minutes

    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)

  7. Six-item State-Trait Anxiety Inventory (STAI-6) (STAI-6) 95 Minutes (Post-Recovery #2)

    Time frame: 95 minutes

    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)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Brain & Behavior Research Foundation
  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jul 10, 2014
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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