Alcohol UsePhase 2NCT03764098
Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders
A Phase 2 study testing Guanfacine ER in people with Alcohol Use, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use
- What is being tested?
- Guanfacine ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2020to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- Meet DSM V criteria for current (past 6 month) ADHD;
- Only one member per household can participate in the study
- 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);
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06510
Meaghan Lavery, 203-737-2783, meaghan.lavery@yale.edu
Sabrina Coppola, 203-737-2827, sabrina.coppola@yale.edu
About this study
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.
Read the detailed description
This study is a double blind, placebo controlled, parallel group design, which will compare guanfacine (6mg/day ER) to placebo (0mg/day) in treatment seeking adults meeting criteria for DSM V alcohol use disorders (160, 40 per med x sex cell).
Eligibility screening consists of an intake session and a physical exam. Subjects meeting eligibility criteria will be randomized to 6mg/day ER guanfacine or matching placebo, stratified by sex. Titration to steady state medication levels will occur over a 3 week period (Weeks minus 3 to minus 1). Subjects will then complete three laboratory sessions during Week 0 to evaluate ad lib consumption.
During each laboratory session, personalized imagery (within subject factor, stress, stimulating, or neutral/relaxing, order balanced) will precede a 2 hour alcohol self-administration period. Subjects will then begin a 6 week treatment phase (Week 1 to 6) where medication is combined with a medical management platform delivered at weekly appointments.
At the end of the treatment phase, medication will be tapered for 5 days, and a final follow up evaluation will occur 1 and 3 months following the end of treatment. Primary outcome measures include the number of drinks consumed during the three self-administration sessions, and reduction in percent heavy days of drinking during treatment.
Adverse events are evaluated at each study appointment and will be tabulated. The date March 1, 2019 was used as the actual start date that was associated with the preliminary funding. The study start date has been updated to reflect the beginning of the U54 grant.
- Conditions
- Alcohol Use
- Being tested
- Guanfacine ER, Placebo
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guanfacine ERDrug
Also called Intuniv
Guanfacine Extended Release (6mg/day ER)
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start10 Aug 2020
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Sherry McKee, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764098
- Sponsor's protocol ID
- 2000023970
- Other IDs
- P01AA027473, U54AA027989
- Status last verified
- Feb 2026
- First submitted
- 3 Dec 2018
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT03764098
- Acronym / sponsor ID
- 2000023970
- Conditions
- Alcohol Use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a double blind, placebo controlled, parallel group design, which will compare guanfacine (6mg/day ER) to placebo (0mg/day) in treatment seeking adults meeting criteria for DSM V alcohol use disorders (160, 40 per med x sex cell).
Eligibility screening consists of an intake session and a physical exam. Subjects meeting eligibility criteria will be randomized to 6mg/day ER guanfacine or matching placebo, stratified by sex. Titration to steady state medication levels will occur over a 3 week period (Weeks minus 3 to minus 1). Subjects will then complete three laboratory sessions during Week 0 to evaluate ad lib consumption.
During each laboratory session, personalized imagery (within subject factor, stress, stimulating, or neutral/relaxing, order balanced) will precede a 2 hour alcohol self-administration period. Subjects will then begin a 6 week treatment phase (Week 1 to 6) where medication is combined with a medical management platform delivered at weekly appointments.
At the end of the treatment phase, medication will be tapered for 5 days, and a final follow up evaluation will occur 1 and 3 months following the end of treatment. Primary outcome measures include the number of drinks consumed during the three self-administration sessions, and reduction in percent heavy days of drinking during treatment.
Adverse events are evaluated at each study appointment and will be tabulated. The date March 1, 2019 was used as the actual start date that was associated with the preliminary funding. The study start date has been updated to reflect the beginning of the U54 grant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guanfacine ER | Experimental | Drug: Guanfacine ERGuanfacine 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. |
| Placebo | Placebo comparator | Other: PlaceboAdministered orally twice a day at 8:00 AM and 8:00 PM Days 1-23, then orally once a day at 8:00 PM. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guanfacine ERAlso: IntunivGuanfacine Extended Release (6mg/day ER) | Drug | Guanfacine ER |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Alcohol Consumption
Time frame: 120 minutes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sherry McKee, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Guanfacine ER in people with Alcohol Use, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meaghan Lavery (203-737-2783, meaghan.lavery@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Consumption (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.