This application proposes a Stage I project targeting substance abusers with end-stage liver or renal disease who are seeking organ transplant. The proposed research is perfectly suited to a Stage I study because substance abuse: (1) causes/exacerbates both liver and renal disease; (2) has a negative impact on transplant outcomes; and (3) poses a barrier to obtaining life-prolonging surgery. At present, no empirically validated treatment exists for organ transplant candidates with co-occurring addiction; in addition, no RCT of any validated substance abuse intervention has been conducted in pre-transplant candidates. Lack of relevant substance abuse services for this population is further worsened because organ transplant patients have difficulty assimilating into community drug treatment programs. Together, these factors suggest the need for a """"""""tailored"""""""" intervention. The proposed approach will allow us to develop and pilot test a homebased (telephone) intervention on a small number of pre-transplant patients to determine if it is sufficiently promising to warrant further evaluation in a Stage II clinical trial. It is hoped that the proposed treatment will result in increased: (1) readiness to change drug use behavior; (2) abstinence, both pre- and post-transplant; (3) treatment adherence; (4) behavioral health; and (4) psychological status/Quality of Life (QOL). Longer term medical outcomes of interest include: (1) being listed for transplant; (2) receiving a transplant; (3) morbidity (e.g., rejection episodes); and (4) mortality. The Transplant & Addiction Program (TAP) is a 12- session telephone intervention that uses motivational interviewing (MI) as its therapeutic platform, supplemented by CBT exercises, health education and contracting. TAP emphasizing abstinence, disease management, and adherence, while de-emphasizing confrontation, labeling, and telling the patient what to do. Because it is home-based, the intervention will be accessible to patients who live far away from their chosen transplant center or who are too ill to attend drug treatment in the community. Following the development and piloting of TAP and adherence/competence scales, 20 subjects will be randomized to TAP + TAU and 20 to TAU alone. For this study, TAU consists of medical management by a designated transplant team (internist, RN transplant coordinator, surgeon, and medical social worker) who will adhere to the research protocol. Subjects will be evaluated at baseline, upon completion of treatment (wk. 12) and at 3 and 6- month follow-up points. Hair analysis, BAL, urine (plasma for those no longer making urine) and collateral reports will serve as the dependent measures of substance use. The medical team will provide information regarding medical status and service utilization to the research team on a monthly basis until such time as the subject dies, is administratively discharged from the program, or the study ends. The focus during the extended follow-up period will be on secondary end-points (i.e., medical outcomes) as well as relapse. If the proposed behavioral intervention proves to be efficacious, we will next propose a Stage II study that will likely involve several transplant centers.
| Haller, Deborah L; Schiano, Thomas; Lewis, Douglas (2012) Is there a better way to monitor abstinence among substance abusers awaiting transplantation? Curr Opin Organ Transplant 17:180-7 |
| Haller, D L; Acosta, M C; Lewis, D et al. (2010) Hair analysis versus conventional methods of drug testing in substance abusers seeking organ transplantation. Am J Transplant 10:1305-11 |
