Does Guanfacine Attenuate Stress-Induced Drinking?

July 6, 2021 updated by: Sherry McKee, Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale Center for Clinical Investigations, Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Guanfacine 3mg/day
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.
Other Names:
  • Tenex
Experimental: Guanfacine 1.5mg/day
Drug: 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.
Other Names:
  • Tenex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 hour self administration period during lab sessions held on days 22 and 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

May 23, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 6, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1308012557
  • R01AA022285 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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