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Transplant and Addiction Project (TAP) - 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00249652
First received: November 3, 2005
Last updated: May 13, 2014
Last verified: October 2005

November 3, 2005
May 13, 2014
September 2003
June 2009   (final data collection date for primary outcome measure)
Abstinence [ Time Frame: 3 month time frame ] [ Designated as safety issue: No ]
  • Abstinence
  • improved behavioral health
  • morbidity and mortality
  • being listed for and receiving transplant
Complete list of historical versions of study NCT00249652 on ClinicalTrials.gov Archive Site
Stage of Change, illness response, psychological stress [ Time Frame: 3 month time frame ] [ Designated as safety issue: No ]
  • Therapeutic alliance
  • acceptance of intervention
Not Provided
Not Provided
 
Transplant and Addiction Project (TAP) - 1
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • End Stage Liver Disease
  • End Stage Renal Disease
  • Substance-Related Disorders
  • Behavioral: TAP
    12-session motivational interviewing-based telephone intervention.
  • Other: TAU
    The usual care group will receive the same medical services they would otherwise receive if they were not in this study.
  • Experimental: TAP
    MI-based phone intervention.
    Intervention: Behavioral: TAP
  • TAU
    Treatment As Usual
    Intervention: Other: TAU
Wagner, C., Haller, D.L., and Olbrisch, M.E. (1996). Journal of Clinical Psychology in Medical Settings, 3, 387-98.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
September 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00249652
NIDA-15772-1, R01-15772-1
Yes
St. Luke's-Roosevelt Hospital Center
St. Luke's-Roosevelt Hospital Center
Not Provided
Principal Investigator: Deborah Haller St. Luke's Roosevelt Hosp Cntr (New York)
St. Luke's-Roosevelt Hospital Center
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP