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Integrative data analysis of clinical trials network studies to examine the impact of psychosocial treatments for black people who use cocaine
Study protocol
Haeny, A. M., McCuistian, C., Burlew, A. K., Ruglass, L. M., Espinosa, A., Jordan, A., Roundtree, C., Lopez, J., & Morgan-López, A. A. (2023). Integrative data analysis of clinical trials network studies to examine the impact of psychosocial treatments for black people who use cocaine: Study protocol. Contemporary Clinical Trials, 133, Article 107329. https://doi.org/10.1016/j.cct.2023.107329
BACKGROUND: Cocaine overdose death rates among Black people are higher than that of any other racial/ethnic group, attributable to synthetic opioids in the cocaine supply. Understanding the most effective psychostimulant use treatment interventions for Black people is a high priority. While some interventions have proven effective for the general population, their comparative effectiveness among Black people remains unknown. To address this gap, our NIDA-funded Clinical Trials Network (CTN) study 0125, will use Integrative Data Analysis (IDA) to examine treatment effectiveness across 9 CTN studies. This manuscript describes the study protocol for CTN-0125.
METHODS: Of the 59 completed randomized clinical trials in the CTN with available datasets, nine met our inclusion criteria: 1) behavioral intervention, 2) targeted cocaine use or use disorder, 3) included sub-samples of participants who self-identified as Black and 4) included outcome measures of cocaine and psychostimulant use and consequences. We aim to 1) estimate scale scores of cocaine use severity while considering study-level measurement non-invariance, 2) compare the effectiveness of psychosocial treatments for psychostimulant use, and 3) explore individual (e.g., concomitant opioid use, age, sex, employment, pre-treatment psychiatric status) and study-level moderators (e.g., attendance/retention) to evaluate subgroup differences in treatment effectiveness.
CONCLUSION: The NIDA CTN provides a unique collection of studies that can offer insight into what interventions are most efficacious for Black people. Findings from our CTN-0125 have the potential to substantially inform treatment approaches specifically designed for Black people who use psychostimulants.