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Does Guanfacine Attenuate Stress-Induced Drinking?

Primary Purpose

Alcohol Drinking

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Guanfacine 3mg/day
Guanfacine 1.5mg/day
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking focused on measuring Alcohol, Drinkers, Guanfacine

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yale Center for Clinical Investigations, Yale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Guanfacine 3mg/day

Guanfacine 1.5mg/day

Placebo

Arm Description

Guanfacine 3mg/day

Guanfacine 1.5mg/day

Placebo

Outcomes

Primary Outcome Measures

mL Per 15 Minutes
mL per 15 minutes during 2-hour ad-lib drinking period

Secondary Outcome Measures

Full Information

First Posted
May 23, 2014
Last Updated
July 6, 2021
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02164422
Brief Title
Does Guanfacine Attenuate Stress-Induced Drinking?
Official Title
Does Guanfacine Attenuate Stress-Induced Drinking?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
Keywords
Alcohol, Drinkers, Guanfacine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guanfacine 3mg/day
Arm Type
Experimental
Arm Description
Guanfacine 3mg/day
Arm Title
Guanfacine 1.5mg/day
Arm Type
Experimental
Arm Description
Guanfacine 1.5mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Guanfacine 3mg/day
Other Intervention Name(s)
Tenex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Guanfacine 1.5mg/day
Other Intervention Name(s)
Tenex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
mL Per 15 Minutes
Description
mL per 15 minutes during 2-hour ad-lib drinking period
Time Frame
2 hour self administration period during lab sessions held on days 22 and 25

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherry A McKee, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Center for Clinical Investigations, Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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Does Guanfacine Attenuate Stress-Induced Drinking?

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