A -- Conduct Second 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 award a sole source contract to the Research Triangle Institute (RTI) to conduct a second follow-up study of participants from the original COMBINE clinical trial, which examined combined medication and behavioral therapies for alcoholism. RTI is uniquely qualified and authorized to undertake this work due to its exclusive ownership of the extensive, previously collected subject data and its prior involvement in both the initial COMBINE trial and its first follow-up study. The second follow-up will involve telephone interviews over four half-hour sessions conducted annually with consenting participants from the original study cohort. RTI will also be responsible for study design, obtaining Institutional Review Board approval, and maintaining confidentiality of participant data throughout the process. This follow-up is critical to longitudinally assess outcomes beyond the prior five-year follow-up funded under the earlier grant. The need for a sole source contract arises from RTI’s possession of confidential participant identifiers, contact information, and data linkage rights, which cannot be lawfully transferred or replicated by another organization. Utilizing RTI exclusively ensures continuity, prevents costly duplication of data collection efforts, and avoids delays that would compromise the research timeline. Interested parties may express interest, but the decision to proceed without competitive bidding remains at the contracting officer’s discretion. The planned contract reflects an efficient and necessary extension of an ongoing research initiative aimed at improving treatments for alcoholism.