Transplant and Addiction Project (TAP) - 1

NCT ID: NCT00249652

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2009-09-30

Brief 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.

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.

Conditions

End Stage Liver Disease; End Stage Renal Disease; Substance-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAP

MI-based phone intervention.

Group Type: EXPERIMENTAL

TAP

Intervention Type: BEHAVIORAL

12-session motivational interviewing-based telephone intervention.

TAU

Treatment As Usual

Group Type: OTHER

TAU

Intervention Type: OTHER

The usual care group will receive the same medical services they would otherwise receive if they were not in this study.

Interventions

TAP

12-session motivational interviewing-based telephone intervention.

Intervention Type: BEHAVIORAL

TAU

The usual care group will receive the same medical services they would otherwise receive if they were not in this study.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah Haller

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Roosevelt Hosp Cntr (New York)

Locations

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, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24226847 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

R01-15772-1

Identifier Type: -

Identifier Source: secondary_id

NIDA-15772-1

Identifier Type: -

Identifier Source: org_study_id