Does Guanfacine Attenuate Stress-Induced Drinking?

Alcohol Drinking Clinical Trial

Official title:

Does Guanfacine Attenuate Stress-Induced Drinking?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164422
• Other study ID #: 1308012557
• Secondary ID: R01AA022285
• Status: Completed
• Phase: Phase 2
• Start date: June 2014
• Est. completion date: March 31, 2020

Study information

• Verified date: July 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Yale Center for Clinical Investigations, Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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