A -- Follow-up of Patients Enrolled in the Combining Medications and Behavioral Interventions (COMBINE) Study

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) intends to negotiate on a sole source basis with the Research Triangle Institute (RTI) to conduct a second follow-up study of subjects who were previously enrolled in a multi-site randomized clinical trial (RCT) of combined medication and behavioral therapy for alcoholism. RTI is the one responsible source that can satisfy the Agency's requirement because (1) RTI is the sole owner of critical previously collected data on human subjects, (2) has extensive experience necessary to conduct the study proposed for the current contract; and (3) no other source can supply the services and data that will satisfy agency requirements for the follow-on work for this study. Development of the original study, called Combining Medications and Behavioral Interventions (COMBINE), was initiated in 1998 and supported by NIAAA under a co-operative agreement. Data collection was begun in 2001. In COMBINE, 1383 subjects were randomized to medications: one, both or neither (placebo) naltrexone or acamprosate combined. In addition to the medication subjects were assigned to either (a) a 16-week behavioral therapy or (b) no behavioral therapy. Eleven recruitment/ treatment sites and one co-coordinating center participated in COMBINE. Extensive information was collected on subjects, including data from numerous questionnaires over several time points, tissue samples and genetic analyses. Staff from the Research Triangle Institute (RTI) participated in development of data collection instruments. A 5-year grant for a follow-up study (Cost Effectiveness of Alcohol Treatment) was awarded to RTI in 2002. Eight hundred thirty-five subjects and 9 of the 11 original study sites participated in this, the first COMBINE follow-up study. Follow-up data but no treatments were administered under this study. A series of in-person interviews were conducted at the 9 participating sites. Data collection for this study will conclude in the fall of 2006. Most participants at the 9 sites provided informed consent to (a) be interviewed and (b) have their data from the COMBINE study, with identifiers, linked to data collected under the first-follow-up study. Under the grant mechanism, these data belong to the grantee, RTI. In addition to these data, the study maintained records of subject location information and one or two personal contacts useful for tracing subjects who moved and/or changed phone numbers. For cost and efficiency purposes, NIAAA plans to conduct the second COMBINE follow-up study using a single contractor (RTI) and telephone interviews. The contractor will help design and gain Institutional Review Board (IRB) approval of the study. Confidential contact information, already maintained through the RTI grant, will be used to track currently-enrolled subjects. Subjects will be provided with details of the new follow-up study and asked to provide informed consent for the new study. Four half-hour telephone interviews, planned at yearly intervals, will be administered to consenting subjects. Development of the interviews will be done by personnel familiar with the COMBINE and first follow-up instruments. As in the first follow-up study, subjects will be asked for their consent to link the data from COMBINE and the first follow-up studies with the second follow-up study. These procedures require that the contractor have access to confidential identifiers and other data. Substantial data (including participants confidentially provided data and list of contacts) which is required to conduct the current study is owned by RTI. Furthermore, participants confidential information may not be passed on to another research organization without prior consent of each participant. As RTI has the unique resources to provide the particular research services proposed, a sole source contract to RTI is the only means to conduct the second follow-up phase as described. Pursuant to 41 U.S.C. 253(c)(1) as set forth in the Federal Acquisition Regulation (FAR) at 6.302-1, the Research Triangle Institute is the only source capable of performing this requirement due their ownership of the data and prerequisite knowledge and experience because of their work under the Cooperative Agreement and performing as the grantee for the COMBINE study under the NIAAA Grant. To begin anew with a different source would result in substantial duplication of cost to the Government that would not be recovered through competition as well as unacceptable delays in obtaining the required data. Interested parties may identify their interest and capability to respond to the requirements as described above. A determination not to compete the proposed work based upon responses to this notice is solely within the discretion of the Contracting Officer. This notice of intent is not an announcement of the availability of a Request for Proposal, nor is an RFP available. See Numbered Note 22.