RECRUITING

Developing a Novel Human Laboratory Paradigm for AUD Medication Screening

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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

The intent of the study is to develop two versions of the 'ability to resist' drinking model designed to screen Alcohol Use Disorder (AUD) medications.

Official Title

Developing a Novel Human Laboratory Paradigm for AUD Medication Screening

Quick Facts

Study Start:2024-11-01

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06489782

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 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Provision of signed and dated informed consent form; 2. Male or Female Age 21-65; 3. Able to read and write English; 4. Meets DSM-5 criteria for current (past 6 months); 5. Drinking criteria: Males - Drinks \> 28 drinks per week and exceeds 4 drinks per day at least once per week; Females -Drinks \> 14 drinks per week and exceeds 3 drinks per day at least once per week. Must meet drinking criteria during 30-day period prior to baseline; 6) Laboratory sessions will be scheduled such that participants will not have major responsibilities on the following day which might limit drinking during the self-administration session (e.g., job interview, exam).	1. Participants with any significant current medical conditions (neurological, cardiovascular, endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions including HIV; 2. Current DSM-5 substance use disorder (other than AUD or tobacco use disorder or mild cannabis dependence); 3. A positive test result at intake appointment on urine drug screens conducted for illicit drugs; 4. 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); 5. Suicidal, homicidal or evidence of current (past 6-month) diagnosis of schizophrenia, or bipolar disorder, or psychosis. Participants diagnosed with psychiatric disorders not specifically listed above may be included at the discretion of the study MD as long as the concurrent treatment for the comorbid psychiatric condition does not compromise the study integrity by virtue of its type, duration, or intensity; 6. Only one member per household can participate in the study; 7. Participants likely to exhibit clinically significant alcohol withdrawal during the study. Specifically, we will exclude participants who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon withdrawal, or b) have a score of \> 8 on the Clinical Institute Withdrawal Assessment scale at intake appointments; 8. Individuals who are currently treatment for drinking or who have attempted to quit drinking within the past 3 months in order to exclude participants seeking treatment; 9. Participants who have taken any investigational drug within 4 weeks of intake; 10. 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 study.

Inclusion Criteria

Exclusion Criteria

1. Provision of signed and dated informed consent form;
2. Male or Female Age 21-65;
3. Able to read and write English;
4. Meets DSM-5 criteria for current (past 6 months);
5. Drinking criteria: Males - Drinks \> 28 drinks per week and exceeds 4 drinks per day at least once per week; Females -Drinks \> 14 drinks per week and exceeds 3 drinks per day at least once per week. Must meet drinking criteria during 30-day period prior to baseline; 6) Laboratory sessions will be scheduled such that participants will not have major responsibilities on the following day which might limit drinking during the self-administration session (e.g., job interview, exam).

1. Participants with any significant current medical conditions (neurological, cardiovascular, endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions including HIV;
2. Current DSM-5 substance use disorder (other than AUD or tobacco use disorder or mild cannabis dependence);
3. A positive test result at intake appointment on urine drug screens conducted for illicit drugs;
4. 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);
5. Suicidal, homicidal or evidence of current (past 6-month) diagnosis of schizophrenia, or bipolar disorder, or psychosis. Participants diagnosed with psychiatric disorders not specifically listed above may be included at the discretion of the study MD as long as the concurrent treatment for the comorbid psychiatric condition does not compromise the study integrity by virtue of its type, duration, or intensity;
6. Only one member per household can participate in the study;
7. Participants likely to exhibit clinically significant alcohol withdrawal during the study. Specifically, we will exclude participants who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon withdrawal, or b) have a score of \> 8 on the Clinical Institute Withdrawal Assessment scale at intake appointments;
8. Individuals who are currently treatment for drinking or who have attempted to quit drinking within the past 3 months in order to exclude participants seeking treatment;
9. Participants who have taken any investigational drug within 4 weeks of intake;
10. 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 study.

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 School of Medicine

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06510

United States

Collaborators and Investigators

Sponsor: Yale University

Sherry McKee, PhD, PRINCIPAL_INVESTIGATOR, Yale School of Medicine

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 Date2024-11-01

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2024-11-01

Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

Alcohol Use Disorder