Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2014-06-30
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Guanfacine 3mg/day
Guanfacine 3mg/day
Guanfacine 3mg/day
3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
Guanfacine 1.5mg/day
Guanfacine 1.5mg/day
Guanfacine 1.5mg/day
1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
Placebo
Placebo
Placebo
Interventions
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Guanfacine 3mg/day
3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
Guanfacine 1.5mg/day
1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
65 Years
ALL
Yes
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Yale University
OTHER
Responsible Party
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Sherry McKee
Professor of Psychiatry
Principal Investigators
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Sherry A McKee, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale Center for Clinical Investigations, Yale University
New Haven, Connecticut, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1308012557
Identifier Type: -
Identifier Source: org_study_id
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