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Progesterone Treatment in Reducing Trauma and Alcohol Induced Craving in Individuals Diagnoses With Alcohol Dependence (AD) and Post-tramatic Stress Disorder (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.
Age
21 - 60 years
Sex
ALL
Healthy Volunteers
No
VA Connecticut Healtcase System
West Haven, Connecticut, United States
Start Date
September 1, 2016
Primary Completion Date
September 8, 2021
Completion Date
September 8, 2021
Last Updated
April 26, 2023
13
ACTUAL participants
Progesterone
DRUG
Placebo (for Progesterone)
DRUG
Lead Sponsor
Yale University
Collaborators
NCT07447089
NCT06939088
Data Source & Attribution
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