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

ConditionAlcohol Use

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age21-70

SponsorYale University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Guanfacine ER
Drug
Guanfacine Extended Release (6mg/day ER)
Placebo
Other intervention
Placebo

Treatment groups

160 Participants

are divided into 2 treatment groups

Group A: Guanfacine ERExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

120 minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov

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