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

Yale University1 个研究点分布在 1 个国家目标入组 13 人开始时间: 2016年9月1日最近更新: 2023年4月26日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Yale University
入组人数: 13
试验地点: 1
主要终点: Visual Analogue Scale of Craving (VASC) 65 Minutes (Pre-Script #2)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 21 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Men and women ages 21 to 60;
•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.

排除标准

•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.

研究组 & 干预措施

Progesterone

Experimental

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)

干预措施: Progesterone (Drug)

Placebo

Placebo Comparator

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)

干预措施: Placebo (for Progesterone) (Drug)