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 U.S | |||||
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) | ||||