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Transplant and Addiction Project (TAP) - 1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00249652
First Posted: November 7, 2005
Last Update Posted: April 14, 2015
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.
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
November 3, 2005
November 7, 2005
April 14, 2015
September 2003
June 2009   (Final data collection date for primary outcome measure)
Abstinence [ Time Frame: 3 month time frame ]
  • 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 ]
  • 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
Intervention Model: Parallel Assignment
Masking: None (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

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00249652
NIDA-15772-1
R01-15772-1
Yes
Not Provided
Not Provided
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
April 2015

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