A Natural History Study of Buprenorphine Diversion, Self-Treatment, and Use of Drug Abuse Treatment Services
The overall purpose of this natural history study is to describe and analyze the nature and consequences of diverted buprenorphine (BUP) use among heroin and/or non-medical pharmaceutical opioid (NMPO) users who meet criteria for DSM-5 opioid use disorder. Our over-arching hypothesis is that more frequent use of diverted BUP for self-treatment is associated with better health outcomes and a greater likelihood of entering drug abuse treatment. The study will be conducted in the Dayton, Ohio, Metropolitan Area, an emerging epicenter of the U.S. heroin epidemic. The study uses a mixed-methods approach and has two phases. In Phase I (formative research), qualitative data will be collected to inform Phase II sample recruitment and refine structured interview instruments. In Phase II (sample recruitment and longitudinal follow-up), we will follow a sequential explanatory mixed-methods design. We will recruit a community-based sample of 400 people with DSM-5 opioid use disorder who have used diverted BUP products in the previous 90 days. The quantitative component will include structured baseline (N=400) and follow-up interviews every 6 months for 2 years. The qualitative component will include 60 semi-structured in-depth interviews. Phase II qualitative sample selection (N=60) will be stratified by latent classes identified through latent class analysis (LCA) of baseline quantitative patterns of illicit BUP and other opioid use. Phase II qualitative data will provide complementary insights into the quantitative findings. The Specific Aims are to:
- Describe key dimensions of BUP diversion, motivations and patterns of BUP and other drug use, HIV/HBV/HCV risk behaviors, history of unintentional overdose, and drug abuse treatment use.
- Identify trajectories of diverted BUP product use over 24 months and analyze their dynamic relationship to health-related outcomes, including opioid use/non-use, HIV/HBV/HCV risk behaviors, unintentional overdose, and drug abuse treatment engagement.
The study is highly significant because it will advance our understanding of crucial scientific research questions on the mechanisms of BUP diversion and relationships between trajectories of diverted BUP use, length of abstinence from other opioids, HIV risk behaviors, unintentional overdose, and drug abuse treatment seeking and engagement. Presently, answers to such basic questions based on prospective data are unknown. Our research questions will provide findings with critical public health impact that could be used to inform the design of interventions to address the NMPO/heroin epidemics and issues of BUP diversion. The proposed study is highly innovative because it will be the first in the U.S. to utilize a longitudinal, mixed-methods approach to analyze BUP diversion and trajectories of use in the context of complex interactions between self-treatment behaviors and use of drug abuse treatment services. Our mixed-methods design is also novel in the use of LCA analysis results to select the qualitative sample.
This study is funded by the NIH/NIDA Grant No. 1R01DA040811
Principal Investigator: Raminta Daniulaityte
Co-Investigators: Robert Carlson; Ramzi Nahhas; Silvia Martins (Columbia University), Sydney Silverstein
Ethnographer: Sydney Silverstein
Research Assistants: Angela Zaragoza