NCT00249652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

5.8 years

First QC Date

November 3, 2005

Last Update Submit

April 13, 2015

Conditions

End Stage Liver DiseaseEnd Stage Renal DiseaseSubstance-Related Disorders

Keywords

End stage liver diseaseEnd stage renal diseaseSubstance-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • Abstinence

    3 month time frame

Secondary Outcomes (1)

  • Stage of Change, illness response, psychological stress

    3 month time frame

Study Arms (2)

TAP

EXPERIMENTAL

MI-based phone intervention.

Behavioral: TAP

TAU

OTHER

Treatment As Usual

Other: TAU

Interventions

TAPBEHAVIORAL

12-session motivational interviewing-based telephone intervention.

TAP
TAUOTHER

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

TAU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Psychotic or other unstable serious psychiatric disorders that preclude full, active participation
  • Moderate to severe hepatic encephalopathy
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Behavioral Science Research Unit

New York, New York, 10025, United States

Location

Renal & Islet Transplant, Center for Liver Disease

New York, New York, 10032, United States

Location

Liver Transplant Program

Richmond, Virginia, 23298, United States

Location

Related Publications (2)

  • 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.

    PMID: 24226847BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

End Stage Liver DiseaseKidney Failure, ChronicSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Study Officials

  • Deborah Haller

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

September 1, 2003

Primary Completion

June 1, 2009

Study Completion

September 1, 2009

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

US(3)