Progesterone Effect on Individuals Diagnoses With AD and PTSD.
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 11/25/2017 |
| Start Date: | September 2016 |
| End Date: | September 2018 |
| Contact: | Elizabeth Ralevski, Ph.D. |
| Email: | elizabeth.ralevski@yale.edu |
| Phone: | (203) 932-5711 |
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 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.
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.
Inclusion Criteria:
1. Men and women ages 18 to 45;
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 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 screens
conducted for opiates, cocaine, marijuana, benzodiazepines, and barbiturates; for
women, 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 or
Bleeding disorders, heart disease, diabetes or history of stroke.
We found this trial at
1
site
West Haven, Connecticut 06516
Principal Investigator: Elizabeth Ralevski, Ph.D.
Phone: 203-932-5711
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