Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Alcohol Craving in Response to the Alcohol Cue Script
Study Overview
Brief 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 ^.
Detailed Description
OBJECTIVE :
To evaluate pexacerfont, an orally available, brain penetrant selective CRH1 antagonist for its ability to modulate emotional and motivational processes in anxious, recently detoxified alcohol dependent patients.
STUDY POPULATION:
Up to 70 anxious, alcohol dependent subjects, aged 21-65 years will be enrolled to complete the study in 50 patients.
DESIGN
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Pexacerfont
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Intervention: Pexacerfont (Drug)
Placebo
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Alcohol Craving in Response to the Alcohol Cue Script
Time Frame: 90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Alcohol Craving in Response to the Stress Script
Time Frame: 90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Secondary Outcomes
No secondary outcomes reported