Does Guanfacine Attenuate Stress-Induced Drinking?

Yale University

Status and phase: Completed; Phase 2

Conditions: Alcohol Drinking

Treatments: Drug: Guanfacine 3mg/day; Drug: Placebo; Drug: Guanfacine 1.5mg/day

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02164422

R01AA022285 (U.S. NIH Grant/Contract)

1308012557

Details and patient eligibility

About

Evaluating the effect of guanfacine on alcohol consumption. The investigators hypothesize that guanfacine versus placebo will decrease the amount of alcohol consumption (mls consumed) during the 2-hour self-administration period across two laboratory sessions.

Enrollment: 70 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 3 patient groups, including a placebo group

Guanfacine 3mg/day

Experimental group

Description:

Guanfacine 3mg/day

Treatment:

Drug: Guanfacine 3mg/day

Guanfacine 1.5mg/day

Experimental group

Description:

Guanfacine 1.5mg/day

Treatment:

Drug: Guanfacine 1.5mg/day

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo