Recruiting

Alcohol Use

Sponsor:

Nicole T Shen

Code:

NCT03267069

Conditions

Alcoholic Liver Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

survey

Study Details

Brief summary:

This prospective, analytic observational study will investigate alcohol recidivism in patients with alcoholic liver disease. All adult subjects presenting with alcoholic liver disease are considered for inclusion. Subjects able to give consent are included.

Conditions

Alcoholic Liver Disease

Study ID

NCT03267069

Start date

Nov 27, 2016

Status verified date

Mar, 2019

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • alcoholic liver disease able to consent

Exclusion Criteria:

  • without alcoholic liver disease unable to consent

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

alcohol liver disease

Patients with alcohol liver disease consenting to participate in the study will be administered an initial survey at inclusion and then follow-up surveys at 3, 6, 9, 12, 15, and 18 month intervals and then 2, 5, and 10 years. There is no intervention cohort, all enrolled will complete the same surveys. Recidivism will be measured by responses to survey questions, clinical interviews documented in the chart, and urine ethnyl glucuronide or blood ethanol testing.

Interventions

survey

surveys will be administered at inclusion and follow-ups

Primary outcome measure

  • alcohol recidivism assessed by questionnaire [ Time Frame: 6 months ]
  • alcohol recidivism assessed by clinical interview [ Time Frame: 6 months ]
  • alcohol recidivism assessed by urine ethyl glucuronide [ Time Frame: 6 months ]
  • alcohol recidivism assessed by blood [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Nicole T Shen, MD

3146095911nts9004@nyp.org

Robert S Brown, MD, MPH

(646) 962-5483rsb2005@med.cornell.edu

Locations

New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center

Recruiting

New York, New York, United States, 10021

Contacts

Nicole T Shen, MD

314-609-5911nts9004@nyp.org

Cecilia M Mero

(646) 962-9358cmm2002@med.cornell.edu

More Information

Sponsor

Nicole T Shen

Last update posted

Mar 13, 2019

Last verified

Mar, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nicole T Shen on 2019-03-13.