Improving treatment for women with co-morbid post-traumatic stress disorder (PTSD) and alcoholism: a randomized placebo-controlled study of the FAAH inhibitor PF-04457845 in trauma-focused cognitive and behavioral therapy with exposure.

Not Applicable

Completed

• Conditions: Post traumatic stress disorder (PTSD) and alcohol dependence (AD).; Mental and Behavioural Disorders

• Registration Number: ISRCTN56834832
• Lead Sponsor: Stockholm Centre for Dependency Disorders (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-13
• Study Completion: 2017-10-15
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Completed
• 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 (35) and clinical examination by a psychiatrist.

Exclusion Criteria

1. Current DSM-IV substance dependence other than nicotine, as determined by the SCID and clinical examination by a psychiatrist and negative urine screen for illicit drugs.
2. Current DSM-IV psychotic, as determined by the 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; (36)) 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 using 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The co-primary outcomes will be:<br>1. Change from baseline in PTSD symptom severity (Clinician-Administered PTSD Scale; CAPS-DX), measured after COPE session 12 and three months post treatment;<br>2. Change from baseline in alcohol consumption per week (grams per week) and heavy drinking days (HDD) derived from Timeline Follow back (TLFB), after COPE session 12 and three months post treatment.

Secondary Outcome Measures

Name	Time	Method
1. PF-04457845 will decrease biomarkers of alcohol consumption (gamma glutamyltransferase (GGT), mean corpuscular volume (MCV), phosphatidylethanol (PEth), carbohydrate deficient transferrin (CDT), and ethylglucuronide (EtG)) <br>2. PF-04457845 will decrease measures of stress, indexed as cortisol in hair. <br>3. Patient baseline characteristics, incl. genotype at loci within genes encoding elements of the EC system, interact with FAAH blockade to influence treatment outcomes.<br><br>Blood samples will be obtained during the screening period, before treatment, for analysis of genetic variation (CNRI,FAAH). Blood samples will be obtained for analysis of alcohol biomarkers (GGT, CDT, PEth) on baseline, after 2, 4, 8, 12 weeks of COPE treatment, and on three month follow-up. Hair samples will be obtained for analysis of cortisol, a biomarker of stress-axis activity, on baseline, on completion of COPE treatment, and on 3 month follow-up.