Status:
COMPLETED
The Effect of NK1R Antagonism on Alcohol Craving and PTSD Symptoms in Alcohol Dependent Patients With PTSD
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Alcohol Dependence
Eligibility:
All Genders
21-50 years
Phase:
PHASE2
Brief Summary
Objective: Alcoholism is highly co-morbid with post traumatic stress disorder (PTSD). Since stress and negative affective states are major relapse triggering factors for alcohol use, the negative sym...
Detailed Description
Objective: Alcoholism is highly co-morbid with post traumatic stress disorder (PTSD). Since stress and negative affective states are major relapse triggering factors for alcohol use, the negative sym...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Alcohol-dependent patients with a diagnosis of PTSD.
- Ages 21 - 50.
- Right-handed.
- Meet the Diagnostic and Statistical Manual (DSM)-IV diagnostic criteria for alcohol dependence (poly-substance abuse is common in younger alcohol-dependent patients and will not be exclusionary) and PTSD.
- Alcohol use within the last month.
- Females of childbearing potential must agree to use a reliable method of birth control during the study. Reliable methods of birth control include barrier methods such as diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices; a partner with a vasectomy; or abstinence from intercourse. Hormonal contraceptives are not adequate in this study, because the study drug can render them less effective.
- EXCLUSION CRITERIA:
- Individuals who present with complicated medical problems requiring intensive medical or diagnostic management.
- Individuals who are infected with the Human Immunodeficiency Virus (HIV).
- Individuals with serious neuro-psychiatric conditions which impair judgment or cognitive function to an extent that precludes them from providing informed consent or complying with treatment, such as psychotic illness or severe dementia (incompetent individuals).
- Individuals who are evaluated and judged by a board certified psychiatrist to be either severely depressed or an imminent risk for suicide, violence, or impulsive behavior, such as self-purging.
- Individuals who are unlikely or unable to complete the treatment program because they are likely to be incarcerated while on the protocol.
- Individuals who are required to receive treatment by a court of law or who are involuntarily committed to treatment.
- Pregnancy or lactation (negative pregnancy test required).
- A history of seizures, other than documented febrile seizures.
- Individuals currently using psychotropic medications will not be eligible for participation in the protocol if they are either unwilling or unable, for medical reasons, to be removed from their medication during hospitalization.
- Individuals in whom aprepitant is contraindicated because they take medications that can interact with this drug. Specifically, aprepitant should not be used concurrently with pimozide, terfenadine, astemizole, or cisapride. Dose-dependent inhibition of cytochrome P450 isoenzyme 3A4 (CYP3A4) by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions
- Inability or unwillingness to participate in an fMRI scan, including presence of metallic objects in the body that would interfere with the scan or pronounced claustrophobia.
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00896038
Start Date
May 1 2009
End Date
August 1 2014
Last Update
November 3 2015
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892