Alcohol DependencePhase 2/3NCT02187224

Progesterone Effect on Individuals Diagnoses With AD and PTSD.

A Phase 2/3 study testing Progesterone in people with Alcohol Dependence and Post-Traumatic Stress Disorder (PTSD), run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 21 to 60 years
Conditions the study is for: Alcohol Dependence, Post-Traumatic Stress Disorder (PTSD)
What is being tested?: Progesterone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2016to 8 Sep 2021
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Connecticut Healtcase System
West Haven, Connecticut, 06516

Other trials in United States

About this study

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

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)
Being tested: Progesterone, Placebo (for Progesterone)
Keywords: Alcohol Dependence, Post-Traumatic stress disorder (PTSD), Progesterone
Medical subject headings: Alcoholism, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ProgesteroneDrug
Placebo (for Progesterone)Drug

Study groups in NCT02187224
Study group	Role	What they receive
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) Receives: 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) Receives: Drug: Placebo (for Progesterone)

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 95 minutes

Secondary outcomes (7)

State Trait Anxiety Inventory (STAI-6) Baseline no Script
Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)
Measured: Baseline
Six-item State-Trait Anxiety Inventory (STAI-6) 10 Minutes (Pre-Script #1)
Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)
Measured: 10 minutes
Six-item State-Trait Anxiety Inventory (STAI-6) 25 Minutes (Post-Script #1)
Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)
Measured: 25 minutes
Six-item State-Trait Anxiety Inventory (STAI-6) 40 Minutes (Post-Recovery #1)
Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)
Measured: 40 minutes
Six-item State-Trait Anxiety Inventory (STAI-6) 65 Minutes (Pre-Script #2)
Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)
Measured: 65 minutes
Six-item State-Trait Anxiety Inventory (STAI-6) 80 Minutes (Post-Script #2)
Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)
Measured: 80 minutes
Six-item State-Trait Anxiety Inventory (STAI-6) (STAI-6) 95 Minutes (Post-Recovery #2)
Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)
Measured: 95 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20168 Sep 2021

First posted10 Jul 2014 (estimated)
Study start1 Sep 2016
Primary completion8 Sep 2021
Study completion8 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Alcohol DependenceStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02187224
Sponsor's protocol ID: 1603017361
Other IDs: 24330
Status last verified: Apr 2023
First submitted: 8 Jul 2014
Last updated: 26 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 38147491

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcohol Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Progesterone Treatment in Reducing Trauma and Alcohol Induced Craving in Individuals Diagnoses With Alcohol Dependence (AD) and Post-tramatic Stress Disorder (PTSD).
ClinicalTrials.gov ID: NCT02187224
Acronym / sponsor ID: 1603017361
Conditions: Alcohol Dependence, Post-Traumatic Stress Disorder (PTSD)
Keywords: Alcohol Dependence, Post-Traumatic stress disorder (PTSD), Progesterone
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: United States Department of Defense, Brain & Behavior Research Foundation
Study start: 1 Sep 2016 (actual)
Primary completion: 8 Sep 2021 (actual)
Study completion: 8 Sep 2021 (actual)
First posted: 10 Jul 2014 (estimated)
Results: Posted 26 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Progesterone	Experimental	Drug: ProgesteroneFor 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)
Placebo	Placebo comparator	Drug: Placebo (for Progesterone)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)

Who may qualify

Ages: 21 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (6 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Progesterone	Drug	Progesterone
Placebo (for Progesterone)	Drug	Placebo

Primary outcome

Visual Analogue Scale of Craving (VASC) Baseline no Script
Time frame: Baseline
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)
Visual Analogue Scale of Craving (VASC) 10 Minutes (Pre-script #1)
Time frame: 10 minutes
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)
Visual Analogue Scale of Craving (VASC) 25 Minutes (Post-Script #1)
Time frame: 25 minutes
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)
Visual Analogue Scale of Craving (VASC) 40 Minutes (Post-Recovery #1)
Time frame: 40 minutes
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)
Visual Analogue Scale of Craving (VASC) 65 Minutes (Pre-Script #2)
Time frame: 65 minutes
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)
Visual Analogue Scale of Craving (VASC) 80 Minutes (Post-Script #2)
Time frame: 80 minutes
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)
Visual Analogue Scale of Craving (VASC) 95 Minutes (Post-Recovery #2)
Time frame: 95 minutes
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)
Visual Analogue Scale of Anxiety (VASA) Baseline no Script
Time frame: Baseline
Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)
Visual Analogue Scale of Anxiety (VASA) 10 Minutes (Pre-Script #1)
Time frame: 10 minutes
Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)
Visual Analogue Scale of Anxiety (VASA) 25 Minutes (Post-Script #1)
Time frame: 25 minutes
Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)
Visual Analogue Scale of Anxiety (VASA) 40 Minutes (Post-Recovery #1)
Time frame: 40 minutes
Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)
Visual Analogue Scale of Anxiety (VASA) 65 Minutes (Pre-Script #2)
Time frame: 65 minutes
Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)
Visual Analogue Scale of Anxiety (VASA) 80 Minutes (Post-Script #2)
Time frame: 80 minutes
Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)
Visual Analogue Scale of Anxiety (VASA) 95 Minutes (Post-Recovery #2)
Time frame: 95 minutes
Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

7 secondary outcomes

State Trait Anxiety Inventory (STAI-6) Baseline no Script
Time frame: Baseline
Six-item State-Trait Anxiety Inventory (STAI-6) 10 Minutes (Pre-Script #1)
Time frame: 10 minutes
Six-item State-Trait Anxiety Inventory (STAI-6) 25 Minutes (Post-Script #1)
Time frame: 25 minutes
Six-item State-Trait Anxiety Inventory (STAI-6) 40 Minutes (Post-Recovery #1)
Time frame: 40 minutes
Six-item State-Trait Anxiety Inventory (STAI-6) 65 Minutes (Pre-Script #2)
Time frame: 65 minutes
Six-item State-Trait Anxiety Inventory (STAI-6) 80 Minutes (Post-Script #2)
Time frame: 80 minutes
Six-item State-Trait Anxiety Inventory (STAI-6) (STAI-6) 95 Minutes (Post-Recovery #2)
Time frame: 95 minutes

Results and safety

Results posted to the registry on 26 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Progesterone All Study Participants	8	7
Placebo All Study Participants	5	5

Primary outcome: Visual Analogue Scale of Craving (VASC) Baseline no Script

Time frame: Baseline. Mean (Standard Error). Unit: units on a scale

Measure	Progesterone n = 7	Placebo n = 5
Value	1.29 (0.78)	0.60 (0.89)

Population analysed: All available data was utilized in the analysis using mixed models

Primary outcome: Visual Analogue Scale of Craving (VASC) 10 Minutes (Pre-script #1)

Time frame: 10 minutes. Mean (Standard Error). Unit: units on a scale

Measure	Progesterone Trauma Script n = 7	Placebo Trauma Script n = 5	Progesterone Neutral Script n = 7	Placebo Neutral Script n = 5
Value	0.16 (1.73)	0 (0.97)	0.81 (0.80)	0.32 (1.75)

Population analysed: All available data was utilized in the analysis using mixed models

Primary outcome: Visual Analogue Scale of Craving (VASC) 25 Minutes (Post-Script #1)

Time frame: 25 minutes. Mean (Standard Error). Unit: units on a scale

Measure	Progesterone Trauma Script n = 7	Placebo Trauma Script n = 5	Progesterone Neutral Script n = 7	Placebo Neutral Script n = 5
Value	2.14 (1.80)	3.93 (0.97)	1.14 (0.80)	0.33 (1.74)

Population analysed: All available data was utilized in the analysis using mixed models

Primary outcome: Visual Analogue Scale of Craving (VASC) 40 Minutes (Post-Recovery #1)

Time frame: 40 minutes. Mean (Standard Error). Unit: units on a scale

Measure	Progesterone Trauma Script n = 7	Placebo Trauma Script n = 5	Progesterone Neutral Script n = 7	Placebo Neutral Script n = 5
Value	1.15 (1.75)	1.92 (0.97)	1.30 (0.79)	0.40 (1.60)

Population analysed: All available data was utilized in the analysis using mixed models

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Progesterone All Study Participants	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Placebo All Study Participants	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38147491Ralevski 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth Ralevski, Ph.D. principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Progesterone in people with Alcohol Dependence and Post-Traumatic Stress Disorder (PTSD), run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale of Craving (VASC) Baseline no Script (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02187224, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.