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Transplant and Addiction Project (TAP) - 1

Drug Treatment for Transplant Candidates

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00249652
Enrollment
41
Registered
2005-11-07
Start date
2003-09-30
Completion date
2009-09-30
Last updated
2015-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

End stage liver disease, End stage renal disease, Substance-Related Disorders

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.

Interventions

BEHAVIORALTAP

12-session motivational interviewing-based telephone intervention.

OTHERTAU

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

Sponsors

St. Luke's-Roosevelt Hospital Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Abstinence3 month time frame

Secondary

MeasureTime frame
Stage of Change, illness response, psychological stress3 month time frame

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026