Transplant and Addiction Project (TAP) - 1
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.
End Stage Liver Disease
End Stage Renal Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Drug Treatment for Transplant Candidates|
- Abstinence [ Time Frame: 3 month time frame ] [ Designated as safety issue: No ]
- Stage of Change, illness response, psychological stress [ Time Frame: 3 month time frame ] [ Designated as safety issue: No ]
|Study Start Date:||September 2003|
|Study Completion Date:||September 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
MI-based phone intervention.
12-session motivational interviewing-based telephone intervention.
Treatment As Usual
The usual care group will receive the same medical services they would otherwise receive if they were not in this study.
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.
Please refer to this study by its ClinicalTrials.gov 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|
|Principal Investigator:||Deborah Haller||St. Luke's Roosevelt Hosp Cntr (New York)|