Progesterone Effect on Individuals Diagnoses With AD and PTSD.

Last updated: April 3, 2023
Sponsor: Yale University
Overall Status: Completed

Phase

2/3

Condition

Alcohol Dependence

Alcohol Use Disorder

Addictions

Treatment

N/A

Clinical Study ID

NCT02187224
1603017361
24330
  • Ages 21-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 screensconducted for opiates, cocaine, marijuana, benzodiazepines, and barbiturates; forwomen, 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 orBleeding disorders, heart disease, diabetes or history of stroke.

Study Design

Total Participants: 13
Study Start date:
September 01, 2016
Estimated Completion Date:
September 08, 2021

Connect with a study center

  • VA Connecticut Healtcase System

    West Haven, Connecticut 06516
    United States

    Site Not Available

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