Can an integrated therapy for Posttraumatic Stress Disorder (PTSD) and Alcohol Dependence (AD) be potentiated with the FAAH inhibitor PF-04457845 to improve the extinction of traumatic memories in women with co-morbid PTSD and AD?

Phase 1

• Conditions: Current Posttraumatic Stress Disorder (PTSD) and Current Alcohol Dependence; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-002456-90-SE
• Lead Sponsor: Stockholm Centre for Dependency Disorders, Department of Clinical Neuroscience, Karolinska Institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-02
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1) Female
2) Age >18 years
3) Diagnosed with current PTSD and current alcohol dependence according to the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV), as determined by The Structured Clinical Interview for DSM IV Disorders and clinical examination by a psychiatrist.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1) Current DSM-IV substance dependence other than nicotine, as determined by SCID and clinical examination by a psychiatrist and negative urine screen for illicit drugs.
2) Current DSM-IV psychotic, as determined by SCID, and clinical examination by a psychiatrist.
3) Clinically significant suicidal or homicidal ideation on clinical assessment with the relevant section of The Mini International Neuropsychiatric Interview (MINI) and clinical examination by a psychiatrist.
4) Any current medication or medical condition that in the judgment of the investigator could interfere with treatment.
5) Pregnancy or nursing. To be eligible, women of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study drug, and agree to use a method of contraception that is adequate in the judgment of the investigator for the duration of the study.
6) Insufficient memory of the trauma (for prolonged exposure to be effective).
7) Dissociative disorder which is more severe or affects the subject more than her PTSD.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified