Progesterone Effect on Individuals Diagnoses With AD and PTSD.

Yale University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Post-Traumatic Stress Disorder (PTSD); Alcohol Dependence

Treatments: Drug: Progesterone; Drug: Placebo (for Progesterone)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02187224

1603017361

24330 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men and women ages 21 to 60;
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

13 participants in 2 patient groups, including a placebo group

Progesterone

Experimental group

Description:

For the three days prior to each test day every participant in this arm will receive one progesterone capsule (200 mg. bid) on the first day and 2 progesterone capsules per day for days 2 and 3. On the test day the participant will receive the last progesterone capsule (200 mg.bid). On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant)

Treatment:

Drug: Progesterone

Placebo

Placebo Comparator group

Description:

For the three days prior to each test day every participant in this arm will receive one placebo capsule on the first day and 2 placebo capsules per day for days 2 and 3. On the test day the participant will receive the last placebo capsule. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant)

Treatment:

Drug: Placebo (for Progesterone)