Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
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 ^.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)