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
  Purpose

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.


Condition Intervention Phase
End Stage Liver Disease
End Stage Renal Disease
Substance-Related Disorders
Behavioral: TAP
Other: TAU
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Abstinence [ Time Frame: 3 month time frame ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stage of Change, illness response, psychological stress [ Time Frame: 3 month time frame ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: September 2003
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAP
MI-based phone intervention.
Behavioral: TAP
12-session motivational interviewing-based telephone intervention.
TAU
Treatment As Usual
Other: TAU
The usual care group will receive the same medical services they would otherwise receive if they were not in this study.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249652

Locations
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
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Deborah Haller St. Luke's Roosevelt Hosp Cntr (New York)
  More Information

Additional Information:
Publications:
Wagner, C., Haller, D.L., and Olbrisch, M.E. (1996). Journal of Clinical Psychology in Medical Settings, 3, 387-98.

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00249652     History of Changes
Other Study ID Numbers: NIDA-15772-1, R01-15772-1
Study First Received: November 3, 2005
Last Updated: May 13, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Liver Diseases
Substance-Related Disorders
End Stage Liver Disease
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Digestive System Diseases
Mental Disorders
Liver Failure
Hepatic Insufficiency

ClinicalTrials.gov processed this record on July 22, 2014