Progesterone Effect on Individuals Diagnoses With AD and PTSD.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02187224
Recruitment Status : Recruiting
First Posted : July 10, 2014
Last Update Posted : November 24, 2017
United States Department of Defense
Information provided by (Responsible Party):
Yale University

Brief Summary:

This is a randomized control trial with 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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Post-Traumatic Stress Disorder (PTSD) Drug: Progesterone Drug: Placebo (for Progesterone) Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Progesterone Treatment in Reducing Trauma and Alcohol Induced Craving in Individuals Diagnoses With Alcohol Dependence (AD) and Post-tramatic Stress Disorder (PTSD).
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Progesterone
For the three days prior to each test day every participant in this arm will receive progesterone.
Drug: Progesterone
Placebo Comparator: Placebo
For the three days prior to each test day every participant in this arm will receive placebo.
Drug: Placebo (for Progesterone)

Primary Outcome Measures :
  1. Visual Analogue Scale - Craving (VASC) [ Time Frame: Test day ]
    Will be used to document the participants degree of craving for alcohol moment.

Secondary Outcome Measures :
  1. State Trait Anxiety Inventory (STAI-6) [ Time Frame: Test day ]
    Will be used to document the participants degree of anxiety

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Men and women ages 18 to 45;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02187224

Contact: Elizabeth Ralevski, Ph.D. (203) 932-5711 ext 4282
Contact: Diana Limoncelli, B.A. (203) 932-5711 ext 5217

United States, Connecticut
VA Connecticut Healtcase System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Elizabeth Ralevski, Ph.D.    203-932-5711 ext 4282   
Principal Investigator: Elizabeth Ralevski, Ph.D.         
Sponsors and Collaborators
Yale University
United States Department of Defense
Principal Investigator: Elizabeth Ralevski, Ph.D. Yale University

Responsible Party: Yale University Identifier: NCT02187224     History of Changes
Other Study ID Numbers: 1603017361
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by Yale University:
Alcohol Dependence
Post-Traumatic stress disorder (PTSD)

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs