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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


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 craving

Number of drinks per week


Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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