Evaluating guanfacine's effects on drinking behavior in individuals with alcohol use disorders

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

This study is testing if the medication guanfacine can help adults with alcohol use disorders drink less, while also looking at any differences between men and women.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 21 Years to 70 Years
• Sex: All
• Sponsor: Yale University (other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT03764098 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to investigate the effects of guanfacine on drinking behavior in adults with alcohol use disorders, focusing on potential sex differences. Participants will be randomly assigned to receive either guanfacine or a placebo in a double-blind manner. The study will include laboratory sessions to assess alcohol consumption and a treatment phase combining medication with medical management. Outcomes will be measured by the number of drinks consumed and the reduction in heavy drinking days during treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 70 who meet DSM V criteria for alcohol use disorders and are willing to reduce their drinking.

Not a fit: Patients with significant medical conditions or those unable to adhere to the medication regimen may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for individuals struggling with alcohol use disorders.

How similar studies have performed: Other studies have explored pharmacological interventions for alcohol use disorders, but this specific approach using guanfacine is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age 21 70;
2. Able to read and write English;
3. 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;
4. 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);
5. Able to take oral medications and willing to adhere to medication regimen;
6. indicate willingness to cut down on drinking during the treatment period.

Exclusion Criteria:

1. 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;
2. Current DSM V substance use disorder, other than alcohol abuse disorder or nicotine dependence;
3. A positive test result at intake appointment on urine drug screens conducted for illicit drugs;
4. Past 30 day use of psychoactive drugs including anxiolytics and antidepressants;
5. 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);
6. Suicidal, homicidal or evidence of current (past 6 month) mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders;
7. Meet DSM V criteria for current (past 6 month) ADHD;
8. Only one member per household can participate in the study
9. 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 (AST, 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 CNS depressant (e.g., phenothiazines, barbiturates, benzodiazepines);
10. 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;
11. Subjects who have taken any investigational drug within 4 weeks immediately preceding admission to the treatment period;
12. 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;
13. at intake express desire to completely abstain from alcohol;
14. currently in treatment for alcohol use

Where this trial is running

New Haven, Connecticut

• Yale University School of Medicine — New Haven, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Sherry McKee, PhD — Yale University
• Study coordinator: Meaghan Lavery

Conditions: Alcohol Use