NCT02187224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2021

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 26, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

5 years

First QC Date

July 8, 2014

Results QC Date

September 13, 2022

Last Update Submit

April 3, 2023

Conditions

Alcohol DependencePost-Traumatic Stress Disorder (PTSD)

Keywords

Alcohol DependencePost-Traumatic stress disorder (PTSD)Progesterone

Outcome Measures

Primary Outcomes (14)

  • Visual Analogue Scale of Craving (VASC) Baseline no Script

    Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

    Baseline

  • Visual Analogue Scale of Craving (VASC) 10 Minutes (Pre-script #1)

    Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

    10 minutes

  • Visual Analogue Scale of Craving (VASC) 25 Minutes (Post-Script #1)

    Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

    25 minutes

  • Visual Analogue Scale of Craving (VASC) 40 Minutes (Post-Recovery #1)

    Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

    40 minutes

  • Visual Analogue Scale of Craving (VASC) 65 Minutes (Pre-Script #2)

    Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

    65 minutes

  • Visual Analogue Scale of Craving (VASC) 80 Minutes (Post-Script #2)

    Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

    80 minutes

  • Visual Analogue Scale of Craving (VASC) 95 Minutes (Post-Recovery #2)

    Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

    95 minutes

  • Visual Analogue Scale of Anxiety (VASA) Baseline no Script

    Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

    Baseline

  • Visual Analogue Scale of Anxiety (VASA) 10 Minutes (Pre-Script #1)

    Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

    10 minutes

  • Visual Analogue Scale of Anxiety (VASA) 25 Minutes (Post-Script #1)

    Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

    25 minutes

  • Visual Analogue Scale of Anxiety (VASA) 40 Minutes (Post-Recovery #1)

    Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

    40 minutes

  • Visual Analogue Scale of Anxiety (VASA) 65 Minutes (Pre-Script #2)

    Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

    65 minutes

  • Visual Analogue Scale of Anxiety (VASA) 80 Minutes (Post-Script #2)

    Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

    80 minutes

  • Visual Analogue Scale of Anxiety (VASA) 95 Minutes (Post-Recovery #2)

    Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

    95 minutes

Secondary Outcomes (7)

  • State Trait Anxiety Inventory (STAI-6) Baseline no Script

    Baseline

  • Six-item State-Trait Anxiety Inventory (STAI-6) 10 Minutes (Pre-Script #1)

    10 minutes

  • Six-item State-Trait Anxiety Inventory (STAI-6) 25 Minutes (Post-Script #1)

    25 minutes

  • Six-item State-Trait Anxiety Inventory (STAI-6) 40 Minutes (Post-Recovery #1)

    40 minutes

  • Six-item State-Trait Anxiety Inventory (STAI-6) 65 Minutes (Pre-Script #2)

    65 minutes

  • +2 more secondary outcomes

Study Arms (2)

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)

Drug: Progesterone

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)

Drug: Placebo (for Progesterone)

Interventions

ProgesteroneDRUG
Progesterone
Placebo (for Progesterone)DRUG
Placebo

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healtcase System

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

  • 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.

    PMID: 38147491DERIVED

MeSH Terms

Conditions

AlcoholismStress Disorders, Post-Traumatic

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Results Point of Contact

Title
Elizabeth Ralevski
Organization
Yale University School of Medicine, Department of Psychiatry
elizabeth.ralevski@yale.edu
203-932-5711

Study Officials

  • Elizabeth Ralevski, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2014

First Posted

July 10, 2014

Study Start

September 1, 2016

Primary Completion

September 8, 2021

Study Completion

September 8, 2021

Last Updated

April 26, 2023

Results First Posted

April 26, 2023

Record last verified: 2023-04

Locations

US(1)