NCT03764098 Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders
| NCT ID | NCT03764098 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Yale University |
| Condition | Alcohol Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2020-08-10 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2020-08-10 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Sherry McKee, PhD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT03764098 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 70 Years, studying Alcohol Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03764098 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03764098 currently recruiting?
Yes, NCT03764098 is actively recruiting participants. Contact the research team at meaghan.lavery@yale.edu for enrollment information.
Where is the NCT03764098 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT03764098 clinical trial?
NCT03764098 is sponsored by Yale University. The principal investigator is Sherry McKee, PhD at Yale University. The trial plans to enroll 160 participants.