Collaborative Clinical Trials in Drug Abuse (R01) | Apply Online

Opportunity Summary:

The Collaborative Clinical Trials in Drug Abuse (R01) funding opportunity (PAR-07-232) is a National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) announcement that supports multi-site clinical trials in the area of drug abuse and addiction treatment. It is a reissuance of an earlier program announcement (PAR-04-073) and is designed to help research teams run the same clinical trial protocol across multiple collaborating locations. The central idea is that certain high-priority questions in substance use disorder treatment cannot be answered well by a single clinic or research center because enrollment would be too small or too slow. By coordinating multiple sites under one shared protocol, investigators can pool participant data to achieve the sample sizes needed for statistically sound, clinically meaningful findings.

The purpose of the program is to increase structured collaboration among investigators and treatment/research sites so they can address outcomes and influences that are best studied with larger, diverse samples. NIDA is looking for trials where combining participants across locations is appropriate and necessary for the hypotheses being tested. The FOA emphasizes studying patient outcomes as well as the factors that shape those outcomes, including patient-level characteristics, provider-level factors, and setting or program characteristics (for example, differences among treatment programs, healthcare systems, or community contexts). It also explicitly invites proposals that examine interactions among these factors, which is often difficult to do without a multi-site design.

Applications are submitted using the NIH Research Project Grant (R01) mechanism. A defining feature of this FOA is the requirement for a collaborative structure: participating sites use a common clinical trial protocol, and one site serves as the coordinating center for the trial. Importantly, each participating site must submit its own separate R01 application rather than a single combined application. Even though foreign institutions may participate as trial sites, the coordinating site must be a domestic (U.S.) institution. This structure reflects NIH expectations that coordination, data harmonization, oversight, and overall trial management be anchored in the United States, while still allowing international participation when it strengthens recruitment, diversity, or generalizability.

Eligibility is broad and includes many types of organizations that might conduct clinical trials or partner with clinical programs. Eligible applicants include public and private institutions of higher education, nonprofit organizations (including those with or without 501(c)(3) status), for-profit organizations (other than small businesses in the listing, though small businesses are also included separately), state and local governments (including county, city/township, special district governments), independent school districts, public housing authorities/Indian housing authorities, Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments). The FOA also notes that foreign institutions are eligible to apply, eligible federal agencies may apply, and faith-based or community-based organizations may apply, which signals an openness to real-world treatment settings and community partners as long as the scientific and administrative requirements of an NIH clinical trial can be met.

From an administrative standpoint, the opportunity is categorized as a discretionary grant in the health area, tied to CFDA number 93.279 (Drug Abuse and Addiction Research Programs). There is no cost sharing or matching requirement. The posting date is listed as February 23, 2007, and the announcement used multiple receipt dates (rather than a single deadline), meaning applications were accepted on recurring standard NIH due dates during the active period of the FOA. The archive date is February 2, 2010, indicating the announcement is no longer active, though it remains useful as a reference for how NIDA has structured multi-site clinical trial funding and what expectations it has set for collaborative designs.

Overall, this FOA supports rigorously designed, multi-site clinical trials in drug abuse and addiction treatment where a shared protocol across collaborating sites is essential to answer questions that depend on larger pooled samples. It also sets clear organizational expectations: separate R01 applications per site, a designated coordinating center, and a U.S.-based coordinating institution even when international sites are involved.

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