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

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

Treatments tested in this trial

  • Guanfacine ER
  • Placebo

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yale University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator