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OpenTrials
Completed

NCT Number: NCT02164422

Does Guanfacine Attenuate Stress-Induced Drinking?

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.

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale Center for Clinical Investigations, Yale University

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guanfacine 3mg/day

Drug

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.

Other names: Tenex

Guanfacine 1.5mg/day

Drug

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.

Other names: Tenex

Placebo

Drug

Primary outcomes

  1. mL Per 15 Minutes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2014
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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