Transplant and Addiction Project (TAP) - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00249652
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : April 14, 2015
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Brief Summary:
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 or disease Intervention/treatment Phase
End Stage Liver Disease End Stage Renal Disease Substance-Related Disorders Behavioral: TAP Other: TAU Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drug Treatment for Transplant Candidates
Study Start Date : September 2003
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
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.

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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)

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
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 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
Substance-Related Disorders
End Stage Liver Disease
Digestive System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Chemically-Induced Disorders
Mental Disorders
Liver Failure
Hepatic Insufficiency