A Combined Group and Individual 12-Step Facilitative Intervention Targeting Stimulant Abuse in the NIDA Clinical Trials Network: STAGE-12

Abstract

This paper discusses a unique collaboration between researchers, addiction community treatment providers (CTPs) and the National Institute on Drug Abuse (NIDA) in developing and implementing a multi-site clinical trial of a behavioral intervention for outpatients with stimulant use disorders. We describe the mission of the Clinical Trial Network (CTN) of NIDA which provided the infrastructure for this study, the process of adapting an intervention that combines individual and group sessions aim at facilitating addicted patients active involvement in 12-step mutual support programs, study questions addressed, outcomes of the intervention and why 12-step counseling approaches should be considered for a multi-site trial. We also discuss the structure and format of individual and group sessions, training and supervision of counselors through review of tapes of treatment sessions. This process emphasizes the importance of bidirectional collaboration between researchers and treatment providers and shows evidence of how CTPs participate in all phases of a trial from identifying an important clinical area to consider for research through protocol development and implementation. Results of data analysis will be presented in a future paper.

KEYWORDS:

• stimulant abuse and dependence
• 12-step programs
• Clinical Trials Network of NIDA
• combined individual and group intervention

Acknowledgments

This study was supported by National Institute on Drug Abuse (NIDA) Clinical Trials Network grants: 5U10DA020036 (Dennis Daley, PI) and U10 DA13714 (Dennis Donovan, PI).

We wish to thank the members of the STAGE-12 protocol development team, the Clinical Coordinating Center (the EMMES Corporation), the Data Management and Statistics Center (Duke Clinical Research Institute), the representatives from community-based treatment programs (CTPs) who responded to surveys about design elements during the development process, the research staff, counselors, supervisors, and the 471 study participants from the 10 CTPs that participated in the protocol.

The opinions are those of the authors and do not represent the official position of the NIDA or the U.S. Government.