RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-08-10

Study Completion:2026-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03764098

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Meaghan Lavery

CONTACT

203-737-2783

meaghan.lavery@yale.edu

Sabrina Coppola

CONTACT

203-737-2827

sabrina.coppola@yale.edu

Principal Investigator

Sherry McKee, PhD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale University School of Medicine

New Haven, Connecticut, 06510

United States

Collaborators and Investigators

Sponsor: Yale University

Sherry McKee, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-10

Study Completion Date2026-02-28

Study Record Updates

Study Start Date2020-08-10

Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

Alcohol Use