Transplant and Addiction Project (TAP) - 1

Phase 1

Completed

• Conditions: Substance-Related Disorders; End Stage Renal Disease; End Stage Liver Disease
• Interventions: Other: TAU; Behavioral: TAP

• Registration Number: NCT00249652
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-11-03
• Study First Submitted QC: 2005-11-03
• Study First Posted: 2005-11-07
• Primary Completion: 2009-06
• Study Completion: 2009-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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Exclusion Criteria

• Psychotic or other unstable serious psychiatric disorders that preclude full, active participation
• Moderate to severe hepatic encephalopathy
• Non-English speaking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU	TAU	Treatment As Usual
TAP	TAP	MI-based phone intervention.

Primary Outcome Measures

Name	Time	Method
Abstinence	3 month time frame

Secondary Outcome Measures

Name	Time	Method
Stage of Change, illness response, psychological stress	3 month time frame

Trial Locations

Locations (3)

Behavioral Science Research Unit; 🇺🇸 New York, New York, United States

Renal & Islet Transplant, Center for Liver Disease; 🇺🇸 New York, New York, United States

Liver Transplant Program; 🇺🇸 Richmond, Virginia, United States