Transplant and Addiction Project (TAP) - 1

April 13, 2015 updated by: St. Luke's-Roosevelt Hospital Center

Drug Treatment for Transplant Candidates

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

41

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • Behavioral Science Research Unit
      • New York, New York, United States, 10032
        • Renal & Islet Transplant, Center for Liver Disease
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Liver Transplant Program

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAP
MI-based phone intervention.
Behavioral: TAP
12-session motivational interviewing-based telephone intervention.
Other: TAU
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Abstinence
Time Frame: 3 month time frame
3 month time frame

Secondary Outcome Measures

Outcome Measure
Time Frame
Stage of Change, illness response, psychological stress
Time Frame: 3 month time frame
3 month time frame

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's-Roosevelt Hospital Center

Investigators

  • Principal Investigator: Deborah Haller, St. Luke's Roosevelt Hosp Cntr (New York)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

November 3, 2005

First Submitted That Met QC Criteria

November 3, 2005

First Posted (Estimate)

November 7, 2005

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-15772-1
  • R01-15772-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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