Does Guanfacine Attenuate Stress-Induced Drinking?
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Drinking
Intervention: Guanfacine 3mg/day (Drug); Guanfacine 1.5mg/day (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s): Sherry A McKee, PhD, Principal Investigator, Affiliation: Yale University
Overall contact: Paula Cunningham, Phone: 203-737-3554
Summary
Evaluating the effect of guanfacine on alcohol consumption. The investigators hypothesize
that guanfacine versus placebo will decrease the number of drinks consumed during the 2-hour
self-administration period across stress and neutral/relaxing conditions.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Number of drinks consumed
Secondary outcome: Alcohol cravingNumber of drinks per week
Eligibility
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 21-65
- Able to read and write English
- Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for
current (past 6 months) alcohol abuse or alcohol dependence
Exclusion Criteria:
- Participants with any significant current medical conditions, seizures, delirium or
hallucinations, or other unstable medical conditions including HIV
- Current DSM-IV abuse or dependence on substances, other than alcohol abuse, alcohol
dependence, or nicotine dependence
- Women who are pregnant or nursing
- Suicidal, homicidal or evidence of current (past 6-month) mental illness
- Meet DSM-IV criteria for current (past-6 month) attention deficit hyperactivity
disorder (ADHD)
- Specific exclusions for administration of guanfacine not already specified include:
EKG evidence at baseline screening of any clinically significant conduction
abnormalities or arrhythmias; known intolerance for guanfacine or any alpha blocker;
history of fainting, syncopal attacks, heart failure or myocardial infarction, or
impaired liver as indicated by aspartate aminotransferase (AST), alanine
aminotransferase (ALT) > 3x normal or renal function (estimated creatinine clearance
<60 cc/min); treatment with any antihypertensive drug or any alpha-adrenergic
blocker; use of any central nervous system (CNS) depressant (e. g., phenothiazines,
barbiturates, benzodiazepines)
- Subjects likely to exhibit clinically significant alcohol withdrawal during the
study.
- Individuals who are seeking treatment for drinking
Locations and Contacts
Paula Cunningham, Phone: 203-737-3554
Yale Center for Clinical Investigations, Yale University, New Haven,, Connecticut 06519, United States; Recruiting Paula Cunningham, Phone: 203-737-3554 Sherry A McKee, PhD, Principal Investigator
Additional Information
Starting date: June 2014
Last updated: April 13, 2015
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