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Transplant and Addiction Project (TAP) - 1

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ClinicalTrials.gov Identifier: NCT00249652
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : April 14, 2015
Sponsor:
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
0
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