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Progesterone Effect on Individuals Diagnoses With AD and PTSD.

Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Dependence; Post-Traumatic Stress Disorder (PTSD)

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

Phase: Phase 2/Phase 3

Status: Not yet recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Elizabeth Ralevski, Ph.D., Principal Investigator, Affiliation: Yale University

Overall contact:
Elizabeth Ralevski, Ph.D., Phone: (203) 932-5711, Ext: 4282, Email: elizabeth.ralevski@yale.edu

Summary

This is a randomized control trial with 34 participants diagnosed with post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Participants will be randomized to receive either Before each test day every participant will 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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Visual Analogue Scale - Craving (VASC)

Secondary outcome: Timeline Follow-Back (TLFB)

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Elizabeth Ralevski, Ph.D., Phone: (203) 932-5711, Ext: 4282, Email: elizabeth.ralevski@yale.edu

Additional Information

Starting date: September 2015
Last updated: July 14, 2015

Page last updated: August 23, 2015

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