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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00249652 |
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 I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Drug Treatment for Transplant Candidates |
| 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:
Exclusion Criteria:
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
| Study ID Numbers: | NIDA-15772-1, R01-15772-1 |
| Study First Received: | November 3, 2005 |
| Last Updated: | November 3, 2005 |
| ClinicalTrials.gov Identifier: | NCT00249652 |
| Health Authority: | United States: Federal Government |
|
Renal Insufficiency Behavior, Addictive Liver Diseases Digestive System Diseases Urologic Diseases Mental Disorders |
Renal Insufficiency, Chronic Substance-Related Disorders Kidney Failure, Chronic Disorders of Environmental Origin Kidney Diseases Kidney Failure |
