News from the Nodes
The Northeast Node is proud to announce two major developments this month: the approval of an ancillary study to CTN-0062-Ot with our partners in Bangor, Maine; and the official release of its National Drug Early Warning System (NDEWS) New Hampshire HotSpot Phase II report.
The Northeast Node and its partners at Penobscot Community Health Care (PCHC), a federally-qualified health center (FQHC) in Bangor, Maine, are teaming up with the Greater New York Node on CTN-0062-Ot to conduct an ancillary study to evaluate an electronic health record (EHR)-based screening and treatment/referral process for primary care patients at three of PCHC's primary care sites in rural Maine (Implementing the Tobacco, Alcohol, Prescription Medication, and Other Substances (TAPS) Tool in rural federally-qualified health centers: An ancillary study of the "CDE-EHR-PC" Study (CTN-0062-Ot-A1)).
The addition of a rural FQHC site will add to knowledge about optimizing the integration of screening into primary care, and enhance the generalizability of the findings from the parent study in New York. The study team hopes that leveraging EHRs in rural FQHC primary care settings will help facilitate integrated care for substance use disorders, enhance meaningful identification and treatment, lessen the impact of substance use on other chronic medical conditions, and reduce morbidity, mortality and healthcare costs for patients in rural areas with substance use disorders. You can read more about the background, specific aims and research strategy of the CTN-0062-Ot-A1 study here.
The Northeast Node, alongside partners at our parent institution (the Dartmouth Center for Technology and Behavioral Health), are pleased to announce the official release of the NDEWS Phase II HotSpot Report, Understanding Opioid Overdoses in New Hampshire.
The aim of the Phase II study was to better understand fentanyl use and opioid overdoses in New Hampshire based on results from the Phase I HotSpot Report that indicated this information was needed to better inform policy in New Hampshire. The NDEWS Phase II Report provides initial analyses of interviews with consumers, first responder, and emergency department (R/ED) personnel who participated in the Phase II study (you can read more about the study here). Specific topics identified by the research team included: trajectory of opioid use, formulation of heroin and fentanyl, fentanyl-seeking behavior, trafficking and supply chain, experiences with overdoses, experiences with Narcan (naloxone), harm reduction, treatment, prevention, and laws and policies.
A full description of the report is available via the Node's website.
The CTN0068 ADAPT-2 study is being led by Madhukar Trivedi, MD, Robrina Walker, PhD, and Walter Ling, MD of the Texas Node. Other Lead Node members are Study Physician, Adriane dela Cruz, MD, PhD; National Project Manager, Mora Kim, MPH; Regulatory Director, Kathy Shores-Wilson, PhD; Biostatistician, Thomas Carmody, PhD; and Financial Director, Angela Casey-Willingham.
ADAPT-2 builds on the lessons learned from the CTN-0054 ADAPT study, investigating the effectiveness and safety of a combination pharmacotherapy for adults 18-65 with moderate or severe methamphetamine use disorder.
After a maximum 21-day screening period which includes a naloxone challenge, 370 participants will be randomized to either the 1) AMC arm and receive injections of extended release naltrexone (XR-NTX; as Vivitrol®) plus once-daily oral extended-release bupropion tablets (BUP-XL) or the 2) matching placebo (PLB) arm and receive injections of placebo (iPLB) plus once-daily oral placebo (oPLB) tablets.
Medication adherence for the oral tablets will be monitored using a smartphone app from AiCure that allows participants to take dosing videos. Use of the app is monitored by staff through the AiCure Dashboard, which also allows the research team to send dosing or visit reminders to participants.
The 12-week medication phase consists of twice weekly study visits, with clinicians providing a Medical Management session during the first visit of each week. During the medication phase, participants may be re-randomized, as determined by the a priori adaptive study design. Participants who appear to be responding well to their originally-assigned arm will not change arms. After the medication phase, participants will complete a medication taper and post-medication phase follow-up visits during weeks 13 and 16.
The primary analysis will evaluate the impact of the AMC arm, relative to PLB, on methamphetamine use. The primary efficacy outcome is a measurement of treatment response based on MA-negative urine drug screen results during the medication phase.
There are 7 ADAPT-2 study sites from 5 Nodes in 6 states. All sites were endorsed in May/early June. Six of the seven sites have at least one randomized participant. As of July 20th, all sites have done an impressive amount of work -- there have been 207 participants pre-screened by phone, 59 have been consented, and 10 have been randomized.
The study as a whole is slightly behind the expected randomizations to date, having achieved 82% of the current goal. UCLA CBAM (PI: Steve Shoptaw) is leading with 3 randomizations. All sites are simultaneously working hard on retention. Intervention adherence is going well and improving daily, with 84% oral medication adherence and 100% injectable medication adherence for active participants. Special recognition goes to UTHealth in Houston (PI: Joy Schmitz) for their low pre-screen to randomization ratio (10 pre-screens : 3 consents : 1 randomization).
Read more about CTN-0068 here. . .
Pacific Northwest Node
The Pacific NW Node and its partners are gearing up to participate three new CTN studies:
Dennis Donovan, PNW Node PI, moderated a panel on Research Opportunities at a recent NIDA meeting on "Future Directions for MAT with American Indian/Alaska Natives." The meeting brought together community members, providers, researchers, government staff and other stakeholders who are involved with treatment and prevention of Opioid Use Disorders in American Indian and Alaska Native communities. The purpose of the meeting was to discuss the acceptability of Medication Assisted Treatment in Indian Country and potentially improve access and adoption of MAT. [more. . .]
The Alcohol & Drug Abuse Institute (ADAI), home of the PNW Node, was awarded a 5-year grant from SAMSHA to support professional education and development of the addiction workforce in Alaska, Idaho, Oregon, and Washington. Beginning in October 2017, ADAI will serve as the Pacific Northwest Addiction Technology Transfer Center (PNATTC), one of 10 regional centers in the national ATTC network established by SAMHSA in 1993.
In June 2017, Dennis Donovan chaired the first meeting of a re-constituted Washington State Treatment Research Subcommittee (TRSC) with the mission to collaboratively develop, conduct, and disseminate research that informs behavioral health policy, treatment, and recovery in Washington State. The TRSC comprises addiction and mental health researchers, the state Division of Behavioral Health and Recovery, Health Care Authority, providers, and other stakeholders. An earlier TRSC met for several years before being disbanded for administrative reasons a number of years ago, but one of its outcomes was ADAI’s initial application to join the CTN in 2001. We hope the new TRSC will be as productive a resource for researchers, state agencies and others working in areas of behavioral health integration and other emerging issues.
The Pacific Northwest Node also offers a farewell and good luck to Dennis Wendt, Ph.D., who has been a postdoctoral fellow at the Alcohol & Drug Abuse Institute (ADAI) for the past two years. During his time with us he authored/co-authored articles on the role of 12-step sponsorship on treatment outcomes based on the STAGE-12 (CTN0031) and the influence of different levels of acculturation on substance use and treatment outcomes among Spanish-speaking Latino/as based on the Spanish MET protocol (CTN0021). He has also been an active member of the American Indian/Alaska Native Special Interest Group.
Dennis will be leaving ADAI and the University of Washington to assume a tenure-track faculty position at McGill University in Montreal, starting August 1.
Congratulations, Dennis -- or in French, a language he will need to learn, félicitations!
From the ATTC
ATTC Messenger July 2017: Treatment and Recovery: Global Perspective from a Hubert Humphrey Fellow, by Samuel Cudjoe Hanu.
From the ATTC/NIATx Service Improvement Blog:
Marijuana policy: Science matters by Susan R. B. Weiss, PhD, and Eric Wargo, PhD, both of NIDA.
The quickest way to reduce time to treatment by Maureen Fitzgerald, ATTC.
Trainings, Webinars, Conferences
Addiction Health Services Research, October 2017
This year's AHSR conference, held in Madison, WI from October 18-20, will feature a wide range of workshops, symposia, and posters.
Early bird registration closes on August 4, so register TODAY to save $125! Find information about the conference, as well as how to apply for investigator awards and mentorships, at the conference website: http://www.fammed.wisc.edu/ahsr2017/.
National Cannabis Summit, August 2017
The preliminary program for the National Cannabis Summit, sponsored by the ATTC Network and held this August in Denver, CO, Advocates for Human Potential, and the National Council for Behavioral Health, is now available. Take a look at the schedule, which includes breakout sessions and lunch discussions covering topics like "Lessons from 10 Years of Cannabis Screening in Colorado," "Teen Culture & Marijuana Use: Which Teens Are At-Risk?" and "Cannabis Use Among Pregnant and Postpartum Women." Read more and register here. . .