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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 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

NCT ID

First Posted

May 23, 2014

Last Updated

July 6, 2021

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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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