Efficacy and Safety Study of PT150 (formerly ORG 34517) in Veterans with Comorbid PTSD and AUD

Background:

Safe, effective treatments for post-traumatic stress disorder (PTSD) alone, alcohol use disorder alone, and both illnesses occurring together are severely limited. There is a great need to develop effective treatments for PTSD, AUD, and co-occurring PTSD and AUD. An emerging awareness of the overlap in PTSD and AUD phenomenology, neural circuitry, and neurobiology provides a rationale to exploit these overlaps for pharmaceutical development for comorbid PTSD and AUD treatment [1, 2]. 

Objectives and Study Design:

This proof of concept study is aimed at examining a novel drug compound (PT150) in Veterans with co-occurring PTSD and AUD to test the efficacy, safety, and tolerability of this drug for PTSD and AUD dual diagnosis treatment. Chronic alcohol consumption disrupts glucocorticoid receptor signaling peripherally and in brain areas that control fear learning processes thought to be aberrant in PTSD. Given this fact, the overarching study goal is to test effects of PT150 treatment on  PTSD and AUD behaviors (e.g. fear learning and alcohol consumption) after 14 days of study drug delivery, as well as to assess subjective symptoms of PTSD and AUD (e.g. consumption and craving) across the entire 28 day study timeframe.

The two primary study objectives are to 1) conduct an outpatient proof of concept clinical trial of study drug (PT150 or placebo) in 40 Veterans with co-occurring PTSD and AUD assessing fear extinction and alcohol use, PTSD and AUD symptoms, and safety and tolerability, and 2) demonstrate that PT150 is safe when taken jointly with alcohol by comparing behavioral and safety endpoints (e.g. vital signs, labs, and adverse events) in 10 Veterans with AUD taking the study drug while following an alcohol challenge protocol. 

This study is innovative and potentially of high impact in that in that it tests a novel compound (PT150) on common co-occurring conditions (PTSD and AUD) using a collection of well-validated, objective biological and behavioral measures in conjunction with subjective symptom measures as a first-step in assessing efficacy and safety of this compound as a pharmaceutical agent for PTSD and AUD.


Sources:

[1] Jacobsen, L. K., Southwick, S. M. & Kosten, T. R. Substance use disorders in patients with posttraumatic stress disorder: a review of the literature. Am J Psychiatry 158, 1184-1190 (2001). 

[2] Koob, G. F. The darkness within: individual differences in stress. Cerebrum 2015, 4 (2015).

 

At a Glance

Study type:

Phase II Clinical Proof of Concept Trial

Objective:

To test the efficacy, safety, and tolerability of PT150 for PTSD and AUD dual diagnosis treatment

Population:

Veterans with co-occurring PTSD and AUD

Number of participants:

40 Veterans

Data collection:

TBD

Participating sites:

VA San Diego Health Care System (VASDHS)

Principal investigators:

Dewleen Baker, M.D., and Victoria Risbrough, Ph.D., University of California, San Diego (UCSD)

Duration:

18 months