Clinical trial NCT02187224: Progesterone Effect on Individuals Diagnoses With AD and PTSD.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alcohol Dependence
Post-Traumatic Stress Disorder (PTSD)
Keywords: Alcohol Dependence
Post-Traumatic stress disorder (PTSD)
Progesterone
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Brain & Behavior Research Foundation
First posted: 2014-07-10
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale of Craving (VASC) Baseline no Script
timeFrame: Baseline
measure: Visual Analogue Scale of Craving (VASC) 10 Minutes (Pre-script #1)
timeFrame: 10 minutes
measure: Visual Analogue Scale of Craving (VASC) 25 Minutes (Post-Script #1)
timeFrame: 25 minutes
measure: Visual Analogue Scale of Craving (VASC) 40 Minutes (Post-Recovery #1)
timeFrame: 40 minutes
measure: Visual Analogue Scale of Craving (VASC) 65 Minutes (Pre-Script #2)
timeFrame: 65 minutes
measure: Visual Analogue Scale of Craving (VASC) 80 Minutes (Post-Script #2)
timeFrame: 80 minutes
measure: Visual Analogue Scale of Craving (VASC) 95 Minutes (Post-Recovery #2)
timeFrame: 95 minutes
measure: Visual Analogue Scale of Anxiety (VASA) Baseline no Script
timeFrame: Baseline
measure: Visual Analogue Scale of Anxiety (VASA) 10 Minutes (Pre-Script #1)
timeFrame: 10 minutes
measure: Visual Analogue Scale of Anxiety (VASA) 25 Minutes (Post-Script #1)
timeFrame: 25 minutes
measure: Visual Analogue Scale of Anxiety (VASA) 40 Minutes (Post-Recovery #1)
timeFrame: 40 minutes
measure: Visual Analogue Scale of Anxiety (VASA) 65 Minutes (Pre-Script #2)
timeFrame: 65 minutes
measure: Visual Analogue Scale of Anxiety (VASA) 80 Minutes (Post-Script #2)
timeFrame: 80 minutes
measure: Visual Analogue Scale of Anxiety (VASA) 95 Minutes (Post-Recovery #2)
timeFrame: 95 minutes
Secondary outcomes:
measure: State Trait Anxiety Inventory (STAI-6) Baseline no Script
timeFrame: Baseline
measure: Six-item State-Trait Anxiety Inventory (STAI-6) 10 Minutes (Pre-Script #1)
timeFrame: 10 minutes
measure: Six-item State-Trait Anxiety Inventory (STAI-6) 25 Minutes (Post-Script #1)
timeFrame: 25 minutes
measure: Six-item State-Trait Anxiety Inventory (STAI-6) 40 Minutes (Post-Recovery #1)
timeFrame: 40 minutes
measure: Six-item State-Trait Anxiety Inventory (STAI-6) 65 Minutes (Pre-Script #2)
timeFrame: 65 minutes
measure: Six-item State-Trait Anxiety Inventory (STAI-6) 80 Minutes (Post-Script #2)
timeFrame: 80 minutes
measure: Six-item State-Trait Anxiety Inventory (STAI-6) (STAI-6) 95 Minutes (Post-Recovery #2)
timeFrame: 95 minutes
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healtcase System
state: Connecticut
Study officials:
affiliation: Yale University
name: Elizabeth Ralevski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: