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Table 2 CTN HEAL Projects

From: The NIDA clinical trials network: evolving, expanding, and addressing the opioid epidemic

CTN No Project title Lead Investigators (Node) Design Outcomes Settings # of Sites (N)
Large, Multi-Site OUD Trials
 CTN-0080 Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): A Pragmatic Randomized Trial Comparing Extended-Release and Daily Buprenorphine Formulations Theresa Winhusen (Ohio Valley) 2-arm RCT (SL-BUP vs. XR-BUP) Illicit opioid use during pregnancy and 12-month postpartum; NOWS severity Office-based 12 (300)
 CTN-0097 Surmounting Withdrawal to Initiate Fast Treatment with Naltrexone (SWIFT): Improving the Real-World Effectiveness of Injection Naltrexone for Opioid Use Disorder Adam Bisaga, Ned Nunes (Greater New York) Cluster randomized trial, 2 arms (rapid vs. standard XR-NTX induction) Proportion of patients receiving first XR-NTX injection Specialty care 6 (Up to 450)
 CTN-0098 Exemplar Hospital Initiation Trial to Enhance Treatment Engagement (EXHIT ENTRE) Gavin Bart (Northstar) Todd Korthuis (Western States) Comparative effectiveness trial, 2 arms (Addiction-Medicine Consultation Services (ACS) with XR-BUP vs. ACS TAU); Implementation trial Proportion of patients engaged in OUD care on 34th day following hospital discharge Hospital 5 (314)
 CTN-0099 Emergency Department-INitiated bupreNOrphine and VAlidaTIOn Network Trial (ED-INNOVATION) Gail D’Onofrio, David Fiellin (New England Consortium) 2 arm RCT (SL-BUP vs. XR-BUP) Effectiveness of XR-BUP and SL-BUP induction in ED on engagement in formal addiction treatment at 7 days Emergency Department RCT 30 (2000)
 CTN-0100 Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy John Rotrosen, Ned Nunes (Greater New York) Roger Weiss (New England Consortium) Retention trial with BUP: 2 behavioral interventions (TAU and TAU + reSET-O) × 3 meds (standard SL-BUP, high SL-BUP, XR-BUP); Retention trial with XR-NTX (TAU vs. TAU + reSET-O); Discontinuation trial for SL-BUP ppts: 2 (TAU and TAU + ACHESS) × 2 (SL-BUP taper and Transition to XR-BUP) Retention in MOUD treatment at 6 months, 1 year, and 2 years; Successful taper within 1 year and no relapse for 6 months post-taper Specialty care Primary care 20 (Retention, N = 1630;
Discontinuation, N = up to 1000)
 CTN-0101 Subthreshold Opioid Use Disorder Prevention (STOP) Trial Jennifer McNeely (Greater New York)
Jane Liebschutz (Appalachian)
Cluster randomized trial, 2 arms (STOP intervention vs. enhanced usual care) Days of “risky” opioid use in adult primary care patients over 6 months of follow-up Primary Care 5 (60 PCPs; 480 patients)
 CTN-0102 Rural Expansion of Medication Treatment for Opioid Use Disorder Yih-Ing Hser (Greater Southern California) Feasibility trial; Pragmatic trial, 2 arms (OBOT vs. OBOT + telemedicine) Proportion of OUD patients initiating or receiving MOUD and retention on MOUD in rural communities Rural Primary care
Telemedicine office-based opioid Treatment
40 (Phase I; N = 48,000); 30
(Phase II; N = 240,000)
Closing the Treatment Gap
 CTN-0088 DC Research Infrastructure Building & Initiative to Reach, Engage, and Retain in MAT patients with OUD Richard Schottenfeld (Mid-Atlantic) Single-arm: collaborative care model of MOUD provision; community-based outreach, engagement, and recovery support interventions Treatment retention, adherence, and satisfaction Specialty care 1 (170)
 CTN-0093 Validation of a Community Pharmacy-based Prescription Drug Monitoring Program Risk Screening Tool (PHARMSCREEN) Gerald Cochran (Greater Intermountain)
Theresa Winhusen (Ohio Valley)
Cross-sectional, self-administered health survey Substance use, risk for adverse opioid-related outcomes Community pharmacy 15 (1523)
 CTN-0095 Clinic-Randomized Trial of Clinical Decision Support for Opioid Use Disorders in Medical Settings Rebecca Rossom, Gavin Bart (Northstar) 2-arm: OUD Clinical Decision Support or Usual Care OUD diagnosis, Naloxone prescription, MOUD orders or referrals, total days covered by MOUD prescription Primary care 30 (1500)
 CTN-0096 Culturally Centered MAT for OUD Implementation Facilitation for Primary Care and Addiction Treatment Programs Serving American Indian/Alaska Natives Kamilla Venner (Southwest)
Aimee Campbell (Greater New York)
Cluster-randomized stepped wedge, 2-phase development and testing of MOUD implementation intervention Proportion of OUD patients initiated on MOUD Primary care
Specialty care
4 (200)
 CTN-0105 Integrating pharmacy-based prevention and treatment of opioid and other substance use disorders: A survey of pharmacists and stakeholders (Pharm-Serve-SUD) Li-Tzy Wu (Mid-Southern) Cross-sectional, one-time survey Knowledge of, attitudes about, and intention to provide patient care and services for SBIRT for MOUD Community pharmacy 1062 licensed community
pharmacists recruited from
pharmacist associations or
pharmacy networks in
 CTN-0107 Peer recovery Support: A Bridge to Treatment for Overdose Survivors Kelly Barth (Southern Consortium) 2-arm (Peer Recovery Coaches vs. TAU) Engagement in formal OUD treatment, retention in treatment, number of overdoses after enrollment Emergency department 3
Expansion of Existing OUD Studies
 CTN-0074-A-1 Primary care Opioid Use Disorder Treatment PROUD Economic Ancillary Study Katharine Bradley
Sean Murphy (Health Systems)
Observational (data collected from randomized controlled trial comparing collaborative care model and usual primary care for OUD) Costs of collaborative care model intervention compared to usual care and net monetary benefit from healthcare sector perspective Primary care 12 (~ 120,000)
 CTN-0079-A-1 Ancillary Study of the Adoption and Sustainability of ED-Initiated Buprenorphine Ryan McCormack John Rotrosen (Greater New York) Implementation and feasibility study Patients assessed, treated, and engaged in treatment; Factors influencing diffusion and effectiveness of clinical protocols for OUD screening, Bup treatment and referral Emergency departments 2 (80–120)
 CTN-0084-A-1 Determining the Optimal Duration of Buprenorphine Treatment to Reduce the Risk of Relapse, Overdose, and Mortality Cynthia Campbell (Health Systems) Observational Risk of relapse, overdose, and mortality Health systems EHR (registry) 10 health systems (1.8 M)
CTN No Project Title Lead Investigators (Node) Database Source    
Database Studies     
 CTN-0084 Developing a Prescription Opioid Registry across Diverse Health Systems Cynthia Campbell (Health Systems) Health Care Systems Research Network (HCSRN) Virtual Data Warehouse (VDW)    
 CTN-0085 Selection Bias-Free Estimation of the Impact of Drug-Focused 12-step Mutual Help Groups Keith Humphreys (Western States) 7 federally-funded randomized clinical trials of Drug Focused 12-Step Groups (DTSG) facilitation interventions    
 CTN-0086 Inpatient versus Outpatient Treatment Outcomes for People with Opioid Use Disorder Daniel Hartung (Western States) Medicaid, Treatment Episodes Data Set (TEDS), and Vital Statistics data in Oregon and Oklahoma    
 CTN-0087 A Foundation to Examine Reasons for Discontinuation for Buprenorphine Care in the Veterans Health Administration Adam Gordon (Greater Intermountain) VA Corporate Data Warehouse (CDW)    
 CTN-0094 Individual Level Predictive Modeling of Opioid Use Disorder Treatment Outcome Sean X. Luo (Greater New York)
Daniel J. Feaster (Florida)
CTN Data Share    
 CTN-0106 Derivation and Validation of New Measurement-Based Care Tools Derived from the Brief Addiction Monitor (BAM) Andrew Saxon
James McKay (Pacific Northwest)
VA Corporate Data Warehouse (CDW)    
CTN No Project Title Lead Investigators (Node)     
Training and Dissemination Studies     
 CTN-0089 Integrating Nurse Practitioner Buprenorphine Wavier Training into Graduate Nursing Curriculum Karen Hartwell Kathleen Brady (Southern Consortium)     
 CTN-0090 Innovatively Increasing PCP Prescribing of Buprenorphine: Measurement Based Care and Integrated Electronic Solution (MBC4OUD) Adriane dela Cruz Madhukar Trivedi (Texas)     
 CTN-0091 Preventing and Identifying Opioid Use Disorder using the Six Building Blocks (6BBs) for Improving Opioid Prescription Management Laura-Mae Baldwin (Pacific Northwest)     
 CTN-0103 Expanding Clinical Research Training on Implementing the Evidence-based Hub and Spoke Model of Medication-Assisted Treatment for Opioid Use Disorder Lisa Marsch (Northeast Node)