Does Guanfacine Attenuate Stress-Induced Drinking?

Study Overview
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Brief Summary
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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.

Official Title
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Does Guanfacine Attenuate Stress-Induced Drinking?

Conditions
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Alcohol Drinking

Intervention / Treatment
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* Drug: Guanfacine 3mg/day
* Drug: Guanfacine 1.5mg/day
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guanfacine 3mg/day<br>Guanfacine 3mg/day | Drug: Guanfacine 3mg/day<br>* 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.<br>* Other names: Tenex;|
| Experimental: Guanfacine 1.5mg/day<br>Guanfacine 1.5mg/day | Drug: Guanfacine 1.5mg/day<br>* 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.<br>* Other names: Tenex;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mL Per 15 Minutes | mL per 15 minutes during 2-hour ad-lib drinking period | 2 hour self administration period during lab sessions held on days 22 and 25 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol, Drinkers, Guanfacine