Progesterone Effect on Individuals Diagnoses With AD and PTSD.

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02187224

Enrollment

Registered

2014-07-10

Start date

2016-09-01

Completion date

2021-09-08

Last updated

2023-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Dependence, Post-Traumatic Stress Disorder (PTSD)

Keywords

Alcohol Dependence, Post-Traumatic stress disorder (PTSD), Progesterone

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.

Interventions

DRUGProgesterone

DRUGPlacebo (for Progesterone)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Visual Analogue Scale of Anxiety (VASA) 95 Minutes (Post-Recovery #2)	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)
Visual Analogue Scale of Craving (VASC) 95 Minutes (Post-Recovery #2)	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	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)	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)	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)	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)	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)	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 Craving (VASC) Baseline no Script	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)	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)	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)	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)	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)	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)

Secondary

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
Progesterone All Study Participants 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) Progesterone	8
Placebo All Study Participants 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) Placebo (for Progesterone)	5
Total	13

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Did not show up for test day	1	0

Baseline characteristics

Characteristic	Placebo All Study Participants	Total	Progesterone All Study Participants
Age, Continuous	49.4 years STANDARD_DEVIATION 11.4	48.9 years STANDARD_DEVIATION 9.75	48.4 years STANDARD_DEVIATION 8.1
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	3 Participants	5 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	2 Participants	8 Participants	6 Participants
Sex: Female, Male Female	0 Participants	1 Participants	1 Participants
Sex: Female, Male Male	5 Participants	12 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 7	0 / 5
other Total, other adverse events	0 / 7	0 / 5
serious Total, serious adverse events	0 / 7	0 / 5

Outcome results

Primary

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)

Time frame: 10 minutes