This is a competing renewal application for the New England Consortium Node (NECN). The NECN, led by Kathleen Carroll, PhD, of Yale, and Roger Weiss, MD, of Harvard, has a track record of outstanding productivity in the Clinical Trials Network (CTN), with leadership of 4 highly successful completed trials, high levels of study participation, excellent recruitment and retention, and 38 peer-reviewed CTN publications during the current funding period. NECN investigators have published the 3 most widely cited papers in the history of the CTN and are currently leading 6 CTN trials. With the recent CTN emphasis on SUD research in general health settings, we have added a third PI, Gail D?Onofrio, MD, currently leading 2 large CTN trials in emergency departments (EDs). The primary aims of this competing renewal application are to: 1) Continue to extend the NECN?s strong clinical research infrastructure into an even wider range of healthcare settings, and 2) Propose a series of studies in an array of healthcare settings to improve interventions for a wide variety of people who use substances, ranging from those with risky substance use to severe substance use disorders (SUDs). These studies, building on previous work of NECN investigators, address critical issues that face practitioners throughout the healthcare system. Proposed studies include the following: 1. Screening, Brief Intervention and Referral to Treatment (SBIRT) vs. SBI with Onsite Computer-based CBT for Stimulant Use Disorder in Primary Care 2. A Randomized Controlled Trial to Prevent or Reduce Substance Use by Youths with Chronic Illness 3. Testing an evidence-based psychosocial treatment for stimulant use disorder and concurrent HIV sexual risk among men who have sex with men 4. Implementation of the Addiction ?Bridge Clinic? Model for General Medical Settings The NECN can provide clinical research access to virtually any substance use population and setting, including primary and specialty care for children and adults, medical and emergency care, medical/surgical hospitalization, psychiatric treatment, and SUD specialty care. Our Node has developed state-of-the-art health information technologies that can be leveraged for CTN studies. The NECN has the ideal mixture of cutting- edge investigators, including national leaders in addiction medicine and specialty care; superb, research- friendly clinical sites; and a track record of innovation, leadership, collaboration, and outstanding productivity in the CTN. We have demonstrated our ability to conduct cost-efficient pragmatic trials of treatments that have directly improved clinical practice. We have the scientific expertise and the clinical and research infrastructure to play key roles in a variety of SUD studies in both general healthcare facilities and specialty SUD treatment programs. We are well prepared to continue to play a key role in all aspects of the CTN.

Public Health Relevance

The National Drug Abuse Treatment Clinical Trials Network (CTN) conducts clinically relevant research on the treatment of substance use disorders in real-world settings, with an increasing emphasis on conducting studies in general medical settings. The New England Consortium Node of the CTN is poised to foster the development of effective, scalable, and sustainable interventions for individuals with a variety of substance use problems, so that they can be offered effective treatment in whatever healthcare setting they enter, thus improving overall public health.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Clinical Research Cooperative Agreements - Single Project (UG1)
Project #
3UG1DA015831-19S4
Application #
10236574
Study Section
Special Emphasis Panel (ZDA1)
Program Officer
Dobbins, Ronald
Project Start
2002-09-30
Project End
2025-02-28
Budget Start
2020-06-01
Budget End
2021-02-28
Support Year
19
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Yale University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
McCollister, Kathryn E; Leff, Jared A; Yang, Xuan et al. (2018) Cost of pharmacotherapy for opioid use disorders following inpatient detoxification. Am J Manag Care 24:526-531
Tomko, Rachel L; Baker, Nathaniel L; McClure, Erin A et al. (2018) Incremental validity of estimated cannabis grams as a predictor of problems and cannabinoid biomarkers: Evidence from a clinical trial. Drug Alcohol Depend 182:1-7
Fitzmaurice, Garrett M; Lipsitz, Stuart R; Weiss, Roger D (2018) Sensitivity analysis for non-monotone missing binary data in longitudinal studies: Application to the NIDA collaborative cocaine treatment study. Stat Methods Med Res :962280218794725
Decker, Suzanne E; Morie, Kristen P; Malin-Mayo, Bo et al. (2018) Positive and negative affect in cocaine use disorder treatment: Change across time and relevance to treatment outcome. Am J Addict :
Campbell, Aimee N C; Barbosa-Leiker, Celestina; Hatch-Maillette, Mary et al. (2018) Gender differences in demographic and clinical characteristics of patients with opioid use disorder entering a comparative effectiveness medication trial. Am J Addict 27:465-470
Winhusen, Theresa; Feaster, Daniel J; Duan, Rui et al. (2018) Baseline Cigarette Smoking Status as a Predictor of Virologic Suppression and CD4 Cell Count During One-Year Follow-Up in Substance Users with Uncontrolled HIV Infection. AIDS Behav 22:2026-2032
McHugh, R Kathryn; Votaw, Victoria R; Sugarman, Dawn E et al. (2018) Sex and gender differences in substance use disorders. Clin Psychol Rev 66:12-23
Korthuis, P Todd; Edelman, E Jennifer (2018) Substance use and the HIV care continuum: important advances. Addict Sci Clin Pract 13:13
Fitzmaurice, Garrett M; Lipsitz, Stuart R; Weiss, Roger D (2017) Statistical considerations in the choice of endpoint for drug use disorder trials. Drug Alcohol Depend 181:219-222
Carroll, Kathleen M; Kiluk, Brian D (2017) Cognitive behavioral interventions for alcohol and drug use disorders: Through the stage model and back again. Psychol Addict Behav 31:847-861

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