Status:
COMPLETED
Progesterone Effect on Individuals Diagnoses With AD and PTSD.
Lead Sponsor:
Yale University
Collaborating Sponsors:
United States Department of Defense
Brain & Behavior Research Foundation
Conditions:
Alcohol Dependence
Post-Traumatic Stress Disorder (PTSD)
Eligibility:
All Genders
21-60 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02187224
Start Date
September 1 2016
End Date
September 8 2021
Last Update
April 26 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
VA Connecticut Healtcase System
West Haven, Connecticut, United States, 06516