Transplant and Addiction Project (TAP) - 1
Primary Purpose
End Stage Liver Disease, End Stage Renal Disease, Substance-Related Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TAP
TAU
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Liver Disease focused on measuring End stage liver disease, End stage renal disease, Substance-Related Disorders
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
Sites / Locations
- Behavioral Science Research Unit
- Renal & Islet Transplant, Center for Liver Disease
- Liver Transplant Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
TAP
TAU
Arm Description
MI-based phone intervention.
Treatment As Usual
Outcomes
Primary Outcome Measures
Abstinence
Secondary Outcome Measures
Stage of Change, illness response, psychological stress
Full Information
NCT ID
NCT00249652
First Posted
November 3, 2005
Last Updated
April 13, 2015
Sponsor
St. Luke's-Roosevelt Hospital Center
1. Study Identification
Unique Protocol Identification Number
NCT00249652
Brief Title
Transplant and Addiction Project (TAP) - 1
Official Title
Drug Treatment for Transplant Candidates
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver Disease, End Stage Renal Disease, Substance-Related Disorders
Keywords
End stage liver disease, End stage renal disease, Substance-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAP
Arm Type
Experimental
Arm Description
MI-based phone intervention.
Arm Title
TAU
Arm Type
Other
Arm Description
Treatment As Usual
Intervention Type
Behavioral
Intervention Name(s)
TAP
Intervention Description
12-session motivational interviewing-based telephone intervention.
Intervention Type
Other
Intervention Name(s)
TAU
Intervention Description
The usual care group will receive the same medical services they would otherwise receive if they were not in this study.
Primary Outcome Measure Information:
Title
Abstinence
Time Frame
3 month time frame
Secondary Outcome Measure Information:
Title
Stage of Change, illness response, psychological stress
Time Frame
3 month time frame
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Haller
Organizational Affiliation
St. Luke's Roosevelt Hosp Cntr (New York)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Science Research Unit
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Renal & Islet Transplant, Center for Liver Disease
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Liver Transplant Program
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24226847
Citation
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.
Results Reference
background
Citation
Presented at the Ninth Annual International Liver Transplantation Society Congress, Barcelona, Spain, June 2003.
Results Reference
background
Learn more about this trial
Transplant and Addiction Project (TAP) - 1
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