Does Guanfacine Attenuate Stress-Induced Drinking?

Phase 2

Completed

• Conditions: Alcohol Drinking
• Interventions: Drug: Guanfacine 1.5mg/day; Drug: Guanfacine 3mg/day; Drug: Placebo

• Registration Number: NCT02164422
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-23
• Study Start: 2014-06
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-16
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Results First Submitted: 2021-03-22
• Results First Submitted QC: 2021-04-16
• Results First Posted: 2021-04-21
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-06
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guanfacine 1.5mg/day	Guanfacine 1.5mg/day	Guanfacine 1.5mg/day
Guanfacine 3mg/day	Guanfacine 3mg/day	Guanfacine 3mg/day
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
mL Per 15 Minutes	2 hour self administration period during lab sessions held on days 22 and 25	mL per 15 minutes during 2-hour ad-lib drinking period

Trial Locations

Locations (1)

Yale Center for Clinical Investigations, Yale University; 🇺🇸 New Haven, Connecticut, United States