Progesterone Effect on Individuals Diagnoses With AD and PTSD.

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT02187224

Collaborator

United States Department of Defense (U.S. Fed), Brain & Behavior Research Foundation (Other)

Enrollment

Location

Arms

60.2

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Dependence Post-Traumatic Stress Disorder (PTSD)	Drug: Progesterone Drug: Placebo (for Progesterone)	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Progesterone Treatment in Reducing Trauma and Alcohol Induced Craving in Individuals Diagnoses With Alcohol Dependence (AD) and Post-tramatic Stress Disorder (PTSD).

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Sep 8, 2021

Actual Study Completion Date :

Sep 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Progesterone For the three days prior to each test day every participant in this arm will receive progesterone.	Drug: 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)

Arm

Intervention/Treatment

Experimental: Progesterone

For the three days prior to each test day every participant in this arm will receive progesterone.

Drug: 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)

Outcome Measures

Primary Outcome Measures

Visual Analogue Scale - Craving (VASC) [Test day]
Will be used to document the participants degree of craving for alcohol moment.

Secondary Outcome Measures

State Trait Anxiety Inventory (STAI-6) [Test day]
Will be used to document the participants degree of anxiety

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men and women ages 18 to 45;
Current diagnosis of AD and PTSD;
Drink regularly are not in an active phase of alcohol withdrawal;
Not at risk for suicide;
Not taking regularly psychoactive drugs including anxiolytics and antidepressants;
For women, have regular menses every 25-35 days.

Exclusion Criteria:

Current SCID diagnosis of any psychotic disorder;
Substance dependence (other than alcohol and nicotine) in the past 30 days;
Current unstable medical condition;
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;
Known allergy to progesterone or peanuts (vehicle for micronized progesterone);
History of thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or Bleeding disorders, heart disease, diabetes or history of stroke.