Transplant and Addiction Project (TAP) - 1

End Stage Renal Disease Clinical Trial

Official title:

Drug Treatment for Transplant Candidates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249652
• Other study ID #: NIDA-15772-1
• Secondary ID: R01-15772-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 3, 2005
• Last updated: April 13, 2015
• Start date: September 2003
• Est. completion date: September 2009

Study information

• Verified date: April 2015
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Liver Disease
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Liver Diseases
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Behavioral Science Research Unit	New York	New York
United States	Renal & Islet Transplant, Center for Liver Disease	New York	New York
United States	Liver Transplant Program	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Presented at the Ninth Annual International Liver Transplantation Society Congress, Barcelona, Spain, June 2003.

Wagner CC, Haller DL, Olbrisch ME. Relapse prevention treatment for liver transplant patients. J Clin Psychol Med Settings. 1996 Dec;3(4):387-98. doi: 10.1007/BF01994021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence		3 month time frame	No
Secondary	Stage of Change, illness response, psychological stress		3 month time frame	No

External Links

•   Link