Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD

PHASE2RecruitingINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

March 4, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Post Traumatic Stress Disorder
Interventions
BEHAVIORAL

3-day differential fear conditioning, extinction, and extinction retention testing paradigm

Day 1: Fear acquisition involving the pairing of a brief, noxious but not painful air blast to the neck (unconditioned stimulus; US) to a conditioned stimuli (CS) (Expts. 1 and 2). The CS will be different colored shapes appearing on a computer monitor. An auditory stimulus will serve as the startle probe. Day 2: Either extinction training (Expt. 1) or fear memory reactivation by a single CS+ with no US (Expt. 2) will occur followed by IV Allo vs. IV placebo administration. Day 3: The effects of IV Allo vs. IV placebo (administered on Day 2) on extinction retention (Expt. 1) or reconsolidation blockade (Expt. 2), as well as reinstatement of conditioned fear (Expts. 1 and 2) will be assessed.

DRUG

Allopregnanolone (Allo) with Dexolve in 0.9% saline for injection manufactured by University of California, Davis

Expt. 1 (extinction retention): On Day 2, a 1.7 ug/kg IV bolus of Allo will be administered over 5 minutes at the completion of extinction training and continued as a 5-hour drip to maintain resting plasma Allo levels at \~1500 pg/ml. Expt. 2 (reconsolidation blockade): On Day 2, a 28 ug/kg IV bolus of Allo will be infused over 30 minutes immediately following presentation of a single CS+.

OTHER

Matching IV Placebo

Expt. 1 (extinction retention): On Day 2, a 1.7 ug/kg IV bolus of the matching placebo formulation will be administered over 5 minutes at the completion of extinction training and continued as a 5-hour drip to maintain resting plasma Allo levels at \~1500 pg/ml. Expt. 2 (reconsolidation blockade): On Day 2, a 28 ug/kg IV bolus of the matching placebo formulation will be infused over 30 minutes immediately following presentation of a single CS+.

Trial Locations (2)

48202

ACTIVE_NOT_RECRUITING

Wayne State University, Detroit

02118

RECRUITING

Boston University School of Medicine, Boston

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Boston University

OTHER