Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders

NCT03764098 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 2000023970P01AA027473U54AA027989
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

For this protocol, the investigators plan to collect pilot data to examine sex differences in guanfacine's effect on 1) counteracting stress and stimulation based drinking behavior in the laboratory and 2) improving clinical outcomes during a subsequent treatment phase.

Conditions

Alcohol Use

Outcome Measures

Primary Outcomes (1)

• Alcohol Consumption

  Means mls of alcohol consumed for guanfacine ER and placebo groups during 120 minute alcohol self administration sessions with personalized stress imagery vs stimulation imagery vs neutral imagery taking place as close to Week 0 of steady state as possible comparing females to males.

  120 minutes

Study Arms (2)

Guanfacine ER

EXPERIMENTAL

Guanfacine extended release (6mg/day ER). Administered orally twice daily at 8:00 AM and 8:00 PM while titrating to the full dose. Titration schedule: Days 1-3 1mg/day; 0.5mg/dose, Days 4-6 2mg/day; 1mg/dose, Days 7-9 3mg/day; 1.5mg/dose, Days 10-12 4mg/day; 2mg/dose; Days 13-15 5mg/day; 2.5mg/dose and Days 16-23 6mg/day; 3mg/dose. Once at steady state, administration is orally once per day at 8:00 PM.

Drug: Guanfacine ER

Placebo

PLACEBO COMPARATOR

Administered orally twice a day at 8:00 AM and 8:00 PM Days 1-23, then orally once a day at 8:00 PM.

Other: Placebo

Interventions

Guanfacine ER DRUG

Guanfacine Extended Release (6mg/day ER)

Also known as: Intuniv

Guanfacine ER

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 70;
• Able to read and write English;
• Meets DSM V criteria for current (past 6 months) alcohol use disorder or Drinking criteria: Males Drinks more than 14 drinks per week and exceeds 4 drinks per day at least twice per week; Females Drinks \> more than 7 drinks per week and exceeds 3 drinks per day at least twice per week. Must meet drinking criteria during a consecutive 30 day period prior to baseline;
• Laboratory sessions will be scheduled such that subjects will not have major responsibilities on the following day which might limit drinking during the self administration session (e.g., job interview, exam);
• Able to take oral medications and willing to adhere to medication regimen;
• indicate willingness to cut down on drinking during the treatment period.

You may not qualify if:

• Subjects with any significant current medical conditions (neurological, cardiovascular \[including hypertension or hypotension: sitting BP more than 160/100 or less than 90/60mmHg at baseline screening\], endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions including HIV;
• Current DSM V substance use disorder, other than alcohol abuse disorder or nicotine dependence;
• A positive test result at intake appointment on urine drug screens conducted for illicit drugs;
• Past 30 day use of psychoactive drugs including anxiolytics and antidepressants;
• Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD);
• Suicidal, homicidal or evidence of current (past 6 month) mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders;
• Meet DSM V criteria for current (past 6 month) ADHD;
• Only one member per household can participate in the study
• Subjects likely to exhibit clinically significant alcohol withdrawal during the study. Specifically, we will exclude subjects who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon withdrawal, or b) have a score of more than 8 on the Clinical Institute Withdrawal Assessment scale at intake appointments;
• Subjects who have taken any investigational drug within 4 weeks immediately preceding admission to the treatment period;
• Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current application;
• at intake express desire to completely abstain from alcohol;
• currently in treatment for alcohol use

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Sherry McKee, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meaghan Lavery

CONTACT

203-737-2783; meaghan.lavery@yale.edu

Sabrina Coppola

CONTACT

203-737-2827; sabrina.coppola@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: August 10, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)