Progesterone Effect on Individuals Diagnoses With AD and PTSD.
Status:
Completed
Trial end date:
2021-09-08
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Yale University
Collaborators:
Brain & Behavior Research Foundation United States Department of Defense