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Transplant and Addiction Project (TAP) - 1

S

St. Luke's-Roosevelt Hospital Center

Status and phase

Completed
Phase 2
Phase 1

Conditions

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

Treatments

Other: TAU
Behavioral: TAP

Study type

Interventional

Funder types

Other

Identifiers

NCT00249652
NIDA-15772-1
R01-15772-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

41 participants in 2 patient groups

TAP
Experimental group
Description:
MI-based phone intervention.
Treatment:
Behavioral: TAP
TAU
Other group
Description:
Treatment As Usual
Treatment:
Other: TAU

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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