Transplant and Addiction Project (TAP) - 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00249652
First received: November 3, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted
  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: Transplant and Addiction Program
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 National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Abstinence
  • improved behavioral health
  • morbidity and mortality
  • being listed for and receiving transplant

Secondary Outcome Measures:
  • Therapeutic alliance
  • acceptance of intervention

Estimated Enrollment: 0
Study Start Date: September 2003
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249652

Contacts
Contact: Michelle C Acosta, Ph.D. (212)523-6977 macosta@chpnet.org

Locations
United States, New York
Behavioral Science Research Unit Recruiting
New York, New York, United States, 10025
Contact: Vanessa Constantine, M.A.    212-523-5232    vconstantine@chpnet.org   
Renal & Islet Transplant, Center for Liver Disease Recruiting
New York, New York, United States, 10032
Contact: Vanessa Constantine, M.A.    212-523-5232    vconstantine@chpnet.org   
United States, Virginia
Liver Transplant Program Recruiting
Richmond, Virginia, United States, 23298
Contact: Vanessa Constantine, M.A.    212-523-5232    vconstantine@chpnet.org   
Sponsors and Collaborators
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.

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: November 3, 2005
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 April 14, 2014