Transplant and Addiction Project (TAP) - 1
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
End Stage Liver Disease End Stage Renal Disease Substance-Related Disorders |
Behavioral: Transplant and Addiction Program |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Drug Treatment for Transplant Candidates |
- Abstinence
- improved behavioral health
- morbidity and mortality
- being listed for and receiving transplant
- Therapeutic alliance
- acceptance of intervention
| Estimated Enrollment: | 0 |
| Study Start Date: | September 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Michelle C Acosta, Ph.D. | (212)523-6977 | macosta@chpnet.org |
| United States, New York | |
| Behavioral Science Research Unit | Recruiting |
| New York, New York, United States, 10025 | |
| Contact: Vanessa Constantine, M.A. 212-523-5232 vconstantine@chpnet.org | |
| Renal & Islet Transplant, Center for Liver Disease | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Vanessa Constantine, M.A. 212-523-5232 vconstantine@chpnet.org | |
| United States, Virginia | |
| Liver Transplant Program | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Vanessa Constantine, M.A. 212-523-5232 vconstantine@chpnet.org | |
| Principal Investigator: | Deborah Haller | St. Luke's Roosevelt Hosp Cntr (New York) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00249652 History of Changes |
| Other Study ID Numbers: | NIDA-15772-1, R01-15772-1 |
| Study First Received: | November 3, 2005 |
| Last Updated: | November 3, 2005 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Liver Diseases Substance-Related Disorders End Stage Liver Disease Urologic Diseases |
Renal Insufficiency, Chronic Renal Insufficiency Digestive System Diseases Mental Disorders Liver Failure Hepatic Insufficiency |
ClinicalTrials.gov processed this record on May 23, 2013