This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Transplant and Addiction Project (TAP) - 1

This study has been completed.
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center Identifier:
First received: November 3, 2005
Last updated: April 13, 2015
Last verified: April 2015
The purpose of this study is to test a novel distance-based (telephone) intervention to help transplant candidates with current or recent substance abuse to stay "clean and sober" both prior and following transplant surgery.

Condition Intervention Phase
End Stage Liver Disease End Stage Renal Disease Substance-Related Disorders Behavioral: TAP Other: TAU Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drug Treatment for Transplant Candidates

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Abstinence [ Time Frame: 3 month time frame ]

Secondary Outcome Measures:
  • Stage of Change, illness response, psychological stress [ Time Frame: 3 month time frame ]

Enrollment: 41
Study Start Date: September 2003
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAP
MI-based phone intervention.
Behavioral: TAP
12-session motivational interviewing-based telephone intervention.
Treatment As Usual
Other: TAU
The usual care group will receive the same medical services they would otherwise receive if they were not in this study.

Detailed Description:
Participants who need a liver or renal transplant and who are ineligible due to current or recent (past 6 months) alcohol and/or other drug abuse are being recruited from the transplant programs at St. Luke's-Roosevelt Hospital Center (renal), Columbia Presbyterian Hospital (renal/liver) and Virginia Commonwealth University Medical Center (liver). Baseline and follow-up computer-assisted assessments and structured clinical interviews along with collection of biological samples (urine, hair) will occur in the transplant clinics; however, phone counseling sessions originate at St. Luke's. Participants are randomly assigned to one of two treatments: (1) usual care (no phone counseling) or (2) usual care + counseling. The telephone counseling sessions are designed to help participants become motivated to remain abstinent and improve other health behaviors such as sleep or stress management.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • End stage liver or renal disease
  • Having used drugs or alcohol during the past 6 months
  • Turned down for transplant due to current or recent substance use
  • Access to telephone

Exclusion Criteria:

  • Psychotic or other unstable serious psychiatric disorders that preclude full, active participation
  • Moderate to severe hepatic encephalopathy
  • Non-English speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00249652

United States, New York
Behavioral Science Research Unit
New York, New York, United States, 10025
Renal & Islet Transplant, Center for Liver Disease
New York, New York, United States, 10032
United States, Virginia
Liver Transplant Program
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Principal Investigator: Deborah Haller St. Luke's Roosevelt Hosp Cntr (New York)
  More Information

Additional Information:
Presented at the Ninth Annual International Liver Transplantation Society Congress, Barcelona, Spain, June 2003.

Responsible Party: St. Luke's-Roosevelt Hospital Center Identifier: NCT00249652     History of Changes
Other Study ID Numbers: NIDA-15772-1
Study First Received: November 3, 2005
Last Updated: April 13, 2015

Keywords provided by St. Luke's-Roosevelt Hospital Center:
End stage liver disease
End stage renal disease
Substance-Related Disorders

Additional relevant MeSH terms:
Liver Diseases
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Substance-Related Disorders
End Stage Liver Disease
Digestive System Diseases
Urologic Diseases
Renal Insufficiency
Chemically-Induced Disorders
Mental Disorders
Liver Failure
Hepatic Insufficiency processed this record on September 21, 2017