Transplant and Addiction Project (TAP) - 1

Study Overview
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Brief Summary
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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
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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.

Official Title
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Drug Treatment for Transplant Candidates

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

Intervention / Treatment
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* Behavioral: TAP
* Other: TAU


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP<br>MI-based phone intervention. | Behavioral: TAP<br>* 12-session motivational interviewing-based telephone intervention.<br>|
| Other: TAU<br>Treatment As Usual | Other: TAU<br>* The usual care group will receive the same medical services they would otherwise receive if they were not in this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence |  | 3 month time frame | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage of Change, illness response, psychological stress |  | 3 month time frame | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End stage liver disease, End stage renal disease, Substance-Related Disorders