Progesterone Effect on Individuals Diagnoses With AD and PTSD.

NCT ID: NCT02187224

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2021-09-08

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.

Conditions

Alcohol Dependence; Post-Traumatic Stress Disorder (PTSD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Progesterone

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)

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: DRUG

Placebo

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)

Group Type: PLACEBO_COMPARATOR

Placebo (for Progesterone)

Intervention Type: DRUG

Interventions

Progesterone

Intervention Type: DRUG

Placebo (for Progesterone)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Brain & Behavior Research Foundation

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Ralevski, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

VA Connecticut Healtcase System

West Haven, Connecticut, United States

Countries

United States

References

Ralevski E, Newcomb J, Pisani E, DeNegre D, Peltier M, Jane JS, Yoon G, Petrakis I. Progesterone Attenuates the Stress Response in Individuals with Alcohol Dependence and Post-Traumatic Stress Disorder - A Pilot Study. J Dual Diagn. 2024 Jan-Mar;20(1):39-51. doi: 10.1080/15504263.2023.2294989. Epub 2024 Feb 1.

Reference Type: DERIVED

PMID: 38147491 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

24330

Identifier Type: OTHER

Identifier Source: secondary_id

1603017361

Identifier Type: -

Identifier Source: org_study_id