Phase
Condition
Alcohol Use Disorder
Addictions
Alcohol Dependence
Treatment
Model 2
Model 1
Clinical Study ID
Ages 21-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed and dated informed consent form;
Male or Female Age 21-65;
Able to read and write English;
Meets DSM-5 criteria for current (past 6 months);
Drinking criteria: Males - Drinks > 28 drinks per week and exceeds 4 drinks per dayat least once per week; Females -Drinks > 14 drinks per week and exceeds 3 drinksper day at least once per week. Must meet drinking criteria during 30-day periodprior to baseline; 6) Laboratory sessions will be scheduled such that participantswill not have major responsibilities on the following day which might limit drinkingduring the self-administration session (e.g., job interview, exam).
Exclusion
Exclusion Criteria:
Participants with any significant current medical conditions (neurological,cardiovascular, endocrine, thyroid, renal, liver), seizures, delirium orhallucinations, or other unstable medical conditions including HIV;
Current DSM-5 substance use disorder (other than AUD or tobacco use disorder or mildcannabis dependence);
A positive test result at intake appointment on urine drug screens conducted forillicit drugs;
Women who are pregnant or nursing, or fail to use one of the following methods ofbirth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection, patch, or ring], contraceptivesponge, double barrier [diaphragm or condom plus spermicide], or IUD);
Suicidal, homicidal or evidence of current (past 6-month) diagnosis ofschizophrenia, or bipolar disorder, or psychosis. Participants diagnosed withpsychiatric disorders not specifically listed above may be included at thediscretion of the study MD as long as the concurrent treatment for the comorbidpsychiatric condition does not compromise the study integrity by virtue of its type,duration, or intensity;
Only one member per household can participate in the study;
Participants likely to exhibit clinically significant alcohol withdrawal during thestudy. Specifically, we will exclude participants who a) have a history ofperceptual distortions, seizures, delirium, or hallucinations upon withdrawal, or b)have a score of > 8 on the Clinical Institute Withdrawal Assessment scale at intakeappointments;
Individuals who are currently treatment for drinking or who have attempted to quitdrinking within the past 3 months in order to exclude participants seekingtreatment;
Participants who have taken any investigational drug within 4 weeks of intake;
Participation within the past 8 weeks in other studies that involve additive bloodsampling and/or interventional measures that would be considered excessive incombination with the current study.
Study Design
Study Description
Connect with a study center
Yale University
New Haven, Connecticut 06510
United StatesActive - Recruiting
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