EUCTR2014-002456-90-SEActive, not recruitingPhase 1
Integrated Exposure-Based Therapy for Co-occurring Posttraumatic Stress Disorder and Alcohol Dependence: Effects of the FAAH inhibitor PF-04457845 on Extinction. A Randomized Controlled Trial. - FAAH Inhibition in PTSD and Alcoholism
Stockholm Centre for Dependency Disorders, Department of Clinical Neuroscience, Karolinska Institutet0 sites120 target enrollmentStarted: September 2, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •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.
Investigators
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