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.|
|ClinicalTrials.gov Identifier: NCT02187224|
Recruitment Status : Recruiting
First Posted : July 10, 2014
Last Update Posted : November 24, 2017
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|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
For the three days prior to each test day every participant in this arm will receive 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)|
- Visual Analogue Scale - Craving (VASC) [ Time Frame: Test day ]Will be used to document the participants degree of craving for alcohol moment.
- State Trait Anxiety Inventory (STAI-6) [ Time Frame: Test day ]Will be used to document the participants degree of anxiety
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 ClinicalTrials.gov identifier (NCT number): NCT02187224
|Contact: Elizabeth Ralevski, Ph.D.||(203) 932-5711 ext email@example.com|
|Contact: Diana Limoncelli, B.A.||(203) 932-5711 ext firstname.lastname@example.org|
|United States, Connecticut|
|VA Connecticut Healtcase System||Recruiting|
|West Haven, Connecticut, United States, 06516|
|Contact: Elizabeth Ralevski, Ph.D. 203-932-5711 ext 4282 email@example.com|
|Principal Investigator: Elizabeth Ralevski, Ph.D.|
|Principal Investigator:||Elizabeth Ralevski, Ph.D.||Yale University|