Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol-Related Disorders, Alcohol Dependence, Alcoholism, Anxiety Disorder

In brief

Background: \- Individuals who are dependent on alcohol often have feelings of anxiety, irritability, anger, and depression. These feelings, as well as stress, may contribute to the risk of relapse and continued drinking. Studies have shown that alcohol consumption increases the activity of certain molecules in the brain known as CRH1 receptors, which are key to producing the body s response to stress, and whose activation generates feelings of anxiety. Researchers are interested in learning whether the experimental drug pexacerfont, which blocks CRH1 receptors and has been studied in individuals with anxiety disorders and depression, can lessen anxiety and craving for alcohol as part of alcohol-dependence treatment. Objectives: \- To determine the safety and effectiveness of pexacerfont as a treatment for anxiety-related alcohol craving. Eligibility: \- Individuals between 21 and 65 years of age who are alcohol-dependent and have problems with anxiety. Design: * This study requires an inpatient admission to the NIH Clinical Center for approximately 1 month, with two additional study visits 1 week and 1 month after discharge from the hospital. * Participants will be screened with a medical history, physical examination, and blood and urine tests. * During the inpatient period, participants will have standard treatment for alcohol dependence, including support and interventions from institute staff to address cravings, anxiety, or other psychological problems. Participants will not receive formal psychological treatment or psychiatric medications for anxiety, but will receive training in relaxation techniques. * Participants will be assigned to take either pexacerfont or placebo for 3 weeks. During this time, participants will have the following procedures: * Frequent blood tests. * Rating scales and questionnaires about alcohol cravings and anxiety. * Dexamethasone suppression test with frequent blood draws to study hormone response to stress. * Social stress test involving public speaking, followed by blood samples and questionnaires on alcohol craving. * Cue Reactivity (CR) session to study cravings and responses to alcohol-based cues. * Functional magnetic resonance imaging scan to evaluate brain activity while taking the medication or placebo. * Participants will have two follow-up visits for additional blood tests and questionnaires about the effects of the treatment \^.

Key facts

Study ID: NCT01227980
Run by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
People needed: 70
Starts: 2010-10-01
Expected to finish: 2014-07-01
Last updated by the study team: 2016-02-02

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

General:
Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
Employees of Bristol-Meyers Squibb (BMS) or immediate family of BMS employees.
Subjects with current participation in another clinical study in which the subject is or will be exposed to an investigational or non investigational drug or device; participation in a clinical study for an illness unrelated to alcohol use within the preceding month; or any previous participation in a trial involving pexacerfont or closely related compounds.
Inability or unwillingness to participate in an MR scan, including presence of ferromagnetic metallic objects in the body, or pronounced claustrophobia
Any medical or psychiatric condition or laboratory finding that, in the judgment of the investigator could adversely affect subject safety or study integrity.
Subjects who are unlikely or unable to complete this study because of impending or likely incarceration while on the protocol.
Subjects who are required to receive treatment by a court of law or involuntarily committed to treatment.
Sex and reproductive status:
Inability or unwillingness to practice contraception as described above
Women who are pregnant, breastfeeding, or planning to become pregnant within 6 months from the administration of first study drug dose.
Men who are planning to father a child within 6 months from the
administration of the first study drug dose
Exclusionary psychiatric conditions:
Past or present diagnosis of schizophrenia, bipolar disease, or any psychotic disorder other than one determined to be substance induced; past or present diagnosis of dementia, or any other disorder which has led to a clinically significant cognitive impairment; any other psychiatric condition which at the present time requires, or in the past month has required pharmacological intervention other than standard withdrawal treatment as described in the NIAAA Assessment and Treatment Protocol (#05-AA-0121).
A personality disorder which, in the investigator s judgment could lead to non-compliance with study procedures.
Subjects, who in the investigator's judgment, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behavior in the last 6 months and/or any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) in the last 2 months.
Positive urine test for illegal drug use.
Exclusionary medical history and concurrent medical conditions:
Subjects with clinically significant thyroid pathology that would interfere with efficacy or safety evaluations, or who are undergoing treatment for their thyroid pathology (e.g., thyroid supplementation).
Subjects with adrenal or pituitary pathology as evidenced by medical history or suggested from abnormal screening laboratory tests.
Subjects with a significant history (as judged by the Investigator) of seizure disorder (e.g., epilepsy or withdrawal seizures), other significant neurological disorders (e.g., Parkinson s Disease, multiple sclerosis, stroke, neurodegenerative disease, cerebral palsy) or severe head trauma.
Subjects with active liver disease or a history of hepatic intolerance to medications that in the Investigator s judgment, is medically significant.
Subjects with a history of Diabetes Mellitus Type I and II or gastric bypass or reduction surgery.
Subjects with Human Immunodeficiency Virus (HIV) infection.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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