Phase 3 N=13 Randomized Triple-blind Treatment

Progesterone Effect on Individuals Diagnoses With AD and PTSD.

Alcohol Dependence · Post-Traumatic Stress Disorder (PTSD)

Bottom Line

View on ClinicalTrials.gov: NCT02187224 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2023

Primary outcome: Primary: Visual Analogue Scale of Craving (VASC) Baseline no Script — 1.29; 0.60 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Progesterone (Drug); Placebo (for Progesterone) (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Analogue Scale of Craving (VASC) Baseline no Script	1.29; 0.60	—
PRIMARY Visual Analogue Scale of Craving (VASC) 10 Minutes (Pre-script #1)	0.16; 0; 0.81; 0.32	—
PRIMARY Visual Analogue Scale of Craving (VASC) 25 Minutes (Post-Script #1)	2.14; 3.93; 1.14; 0.33	—
PRIMARY Visual Analogue Scale of Craving (VASC) 40 Minutes (Post-Recovery #1)	1.15; 1.92; 1.30; 0.40	—
PRIMARY Visual Analogue Scale of Craving (VASC) 65 Minutes (Pre-Script #2)	0.82; 0.20; 3.19; 0	—
PRIMARY Visual Analogue Scale of Craving (VASC) 80 Minutes (Post-Script #2)	3.15; 2.27; 1.13; 0	—
PRIMARY Visual Analogue Scale of Craving (VASC) 95 Minutes (Post-Recovery #2)	1.81; 4.31; 2.14; 0	—
PRIMARY Visual Analogue Scale of Anxiety (VASA) Baseline no Script	0.64; 3.20	—
PRIMARY Visual Analogue Scale of Anxiety (VASA) 10 Minutes (Pre-Script #1)	0; 1.26; 0.20; 0	—
PRIMARY Visual Analogue Scale of Anxiety (VASA) 25 Minutes (Post-Script #1)	2.82; 7.98; 0.03; 0	—
PRIMARY Visual Analogue Scale of Anxiety (VASA) 40 Minutes (Post-Recovery #1)	0; 4.39; 0.85; 0	—
PRIMARY Visual Analogue Scale of Anxiety (VASA) 65 Minutes (Pre-Script #2)	0.18; 0; 0; 2.15	—
PRIMARY Visual Analogue Scale of Anxiety (VASA) 80 Minutes (Post-Script #2)	3.67; 9.89; 0; 1.90	—
PRIMARY Visual Analogue Scale of Anxiety (VASA) 95 Minutes (Post-Recovery #2)	1.68; 9.76; 0; 2.05	—
SECONDARY State Trait Anxiety Inventory (STAI-6) Baseline no Script	7.86; 9.60	—
SECONDARY Six-item State-Trait Anxiety Inventory (STAI-6) 10 Minutes (Pre-Script #1)	6.00; 7.50; 6.50; 5.00	—
SECONDARY Six-item State-Trait Anxiety Inventory (STAI-6) 25 Minutes (Post-Script #1)	11.00; 16.25; 6.17; 5.00	—
SECONDARY Six-item State-Trait Anxiety Inventory (STAI-6) 40 Minutes (Post-Recovery #1)	9.00; 14.00; 7.07; 8.00	—
SECONDARY Six-item State-Trait Anxiety Inventory (STAI-6) 65 Minutes (Pre-Script #2)	6.50; 5.00; 9.00; 9.00	—
SECONDARY Six-item State-Trait Anxiety Inventory (STAI-6) 80 Minutes (Post-Script #2)	14.17; 18.00; 6.00; 8.50	—
SECONDARY Six-item State-Trait Anxiety Inventory (STAI-6) (STAI-6) 95 Minutes (Post-Recovery #2)	11.17; 14.00; 8.00; 8.25	—

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02187224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.