Trials / Completed
CompletedNCT00249652
Transplant and Addiction Project (TAP) - 1
Drug Treatment for Transplant Candidates
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- St. Luke's-Roosevelt Hospital Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | TAP | 12-session motivational interviewing-based telephone intervention. |
| OTHER | TAU | The usual care group will receive the same medical services they would otherwise receive if they were not in this study. |
Timeline
- Start date
- 2003-09-01
- Primary completion
- 2009-06-01
- Completion
- 2009-09-01
- First posted
- 2005-11-07
- Last updated
- 2015-04-14
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00249652. Inclusion in this directory is not an endorsement.