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The importance of implementing evidence-based practices has taken over health care, whether in the mental health, medical, or substance use treatment realms. While well-intentioned and important, the implementation of evidence-based practices is only one aspect of quality care. In fact, there are many other elements of treatment that are at least as important as offering evidence-based practices, and this is particularly true in levels of care other than traditional outpatient. Other elements of care essential to quality treatment include: 1) Monitoring and ensuring a positive therapeutic alliance between clients and providers – Much research has documented the relationship between positive treatment outcome and a positive therapeutic alliance; 2) Monitoring and ensuring high customer satisfaction: Regardless of the specific treatment offered, it is essential to monitor and address customer satisfaction, as without this, clients will not obtain benefit from treatment; 3) Monitoring administrative discharges – In residential treatment programs, clients are often discharged for non-compliance with treatment. This needs close monitoring, as from experience, administrative discharges have more to do with staff than with clients; 4) Ensuring readily-available treatment access – When individuals are ready to enter treatment, treatment needs to be available. Treatment not being available or long waiting periods to enter treatment will result in lost opportunities; 5) Monitoring no-show rates and overall treatment retention – People have to come to treatment and be retained for treatment to be effective. Thus, a focus on this is necessary; 6) Ensuring clients – multiple treatment needs are addressed – Either in-house or through linkages, clients – other problems need to be addressed; and 7) Ongoing quality improvement – To ensure quality treatment, a culture of continuous quality improvement must be developed.
This presentation will highlight other important aspects of care that must not be forgotten while programs are focused on implementing evidence-based practices.
In addition to the studies underway, CTN participants are planning multi-site clinical trials with emerging results that address HIV/AIDS. The CTN has a HIV/AIDS Special Interest Group (SIG) that meets regularly to discuss study ideas and policy approaches. The SIG provides a supportive place to discuss HIV research related to the CTN, share information with each other about opportunities and developments, promote AIDS ideas and research in the CTN, and link CTN research with the AIDS Research Office of NIDA. The SIG periodically reviews and prioritizes study ideas before they work their way up the organizational hierarchy, and, in the latest CTN Call for Concepts, had developed approximately ten suggestions for HIV-related research studies.
Several studies using the CTN ?platform? have also been fielded with external resources. The term ?platform study? describes extramurally funded research that builds on the CTN infrastructure. Studies can add a dimension to a CTN trial, test an intervention by using the infrastructure of the CTN, focus on CTN programs to understand an issue, include CTN programs in data collection, or provide training or career development in the CTN. Extramurally funded platform studies are addressing such issues as models of care for HIV and hepatitis, integrating medical treatment with addiction treatment, and improving adherence to HIV medications.
Stimulants are the drivers of the fourth wave of the United States drug overdose epidemic. Kappa opioid receptor antagonists promote feelings of wellbeing and represent a medication addressing the “dark side.” In a pilot study, extended-release naltrexone (XR-NTX) plus oral buprenorphine (BUP), 4mg and 16mg, produced modest, though statistically significant, reductions in cocaine use among those adherent to oral BUP compared to placebo. This presentation describes CTN-0110, a study designed to test monotherapy for buprenorphine as the medication is used for treatment of refractory depression in people with no opioid use disorder (OUD).
Related protocols: CTN-0110
This presentation was delivered as part of a symposium at the 2024 CPDD conference entitled, “Two-Eyed Seeing for Opioid Use Disorder Treatment and Recovery with American Indian and Alaska Native Communities,” moderated by Aimee Campbell and Carmen Rosa. In this section of the symposium, Dr. Patten discussed the development and testing of a novel, moderated, private Facebook group intervention to support AI/AN women in opioid use disorder recovery. The intervention was developed through feedback from key partners and beta tested and refined with AI/AN women in recovery.
Related protocols: CTN-0123
COVID-19 exacerbated the opioid-related poisoning crisis among many American Indian/Alaska Native (AI/AN) communities. There is a lack of research examining the extent of the impact of the pandemic on the delivery of treatment for opioid use disorder (OUD) in this population. In collaboration with an Indigenous Collaborative Board, Tribal leadership and administration, this study, part of CTN-0118, explored AI/AN SUD-serving treatment providers’ experiences delivering treatment for OUD from 2020-2022. Eligible providers (N=25) represented 6 programs and organizations serving Tribal and urban areas primarily in the Pacific Northwest. Two members of the research team independently reviewed transcripts before reaching consensus on a finalized codebook and analysis was informed by a qualitative descriptive approach. Findings indicated providers viewed the changes to telemedicine, medication dosing, and the introduction of mobile services as a positive and increased access to care. Barriers remained, however, including when programs discontinued services and reverted to pre-pandemic policy (e.g., no longer mailing prescriptions). This study highlights the impact of the COVID-19 pandemic and what was perceived as effective in the delivery and sustainment of telemedicine, medications, as well as the continued necessity to provide a menu of treatment and social service options to meet the unique needs of AI/AN communities. Study results may inform future programmatic and organizational systems change among AI/AN communities to enhance access and SUD service engagement beyond emergency response efforts.
Related protocols: CTN-0118
Opioid and other substance related deaths continue to rise in the U.S. (CDC, May 2022). A treatment model that includes professionals working across disciplines and settings, especially primary care – which is the most common point of healthcare contact – could help address the opioid and substance use crisis by increasing access to evidence based screening and interventions. The National Institute on Drug Abuse (NIDA) Drug Treatment Clinical Trials Network (CTN) has conducted several trials in these settings and this session will provide insights from investigators on successful models for substance and opioid use disorders (SUD/OUD) screening, prevention, and treatment in primary care.
This session will provide an overview and rationale of establishing primary care models for screening and interventions for SUD, and the main objectives are to learn about (1) approaches for incorporating alcohol and drug screening into primary care practices, integrated with the electronic health record (EHR); (2) lessons learned from SUD collaborative care trials in primary care settings; and (3) establishing collaborative care models in Federally Qualified Health Centers (FQHC), including pharmacists, in SUD/OUD treatment and management.
Presentation Slides:
- CTN and the expansion of SUD treatment delivery in primary care settings – C. Rosa, M.S.
- Primary care provider role in SUD screening, prevention, and treatment – G. Bart, M.D.
- Feasibility of implementing alcohol and drug screening in primary care – J. McNeely, MD, MS
- Lessons learned and unanswered questions from trials of collaborative care for alcohol and substance use disorders – K. Bradley, M.D.
- Pharmacist-Integrated Collaborative Care in OUD Treatment – L. Marsch, PhD
The NIDA CCTN convened stakeholders, experts, and federal staff to discuss and identify research and other efforts needed to continue to improve care for people with opioid use disorder and other substance use disorders in emergency settings. An aspirational goal is for ED-initiated buprenorphine to be the standard of care in every emergency department across the United States.
Slides available for:
Day One:
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- Welcome/Meeting Goals – Betty Tai, PhD and Kristen Huntley, PhD, CCTN
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- Current Status of ED Initiation of Buprenorphine for OUD in EDs – Edouard Coupet Jr., MD, MS, Yale School of Medicine
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- SAMHSA Efforts to Enhance ED Care for OUD – Robert Baillieu, MD, MPH, SAMHSA
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- American College of Emergency Physicians (ACEP) Activities to Address the Overdose Epidemic – Sandy Schneider, MD, FACEP, ACEP
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- Research in the Field: Paramedic-Administered Buprenorphine – Martha Waller, PhD, MA, Pacific Inst. for Research and Evaluation
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- Health Coach, Peer, & Navigator Interventions in EDs – Kelly Barth, DO, Medical University of South Carolina
- CReDO: Community Response to Drug Overdoses – Roneet Lev, MD, FACEP, Scripps Mercy Hospital
Day Two:
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- Stakeholder Voices – Perspectives of Clinicians & Health Systems – Arjun Venkatesh, MD, MBA, MHS (Yale School of Medicine), Tania Strout, PhD, RN, MS (Tufts University School of Medicine), Jason Wilson, MD, MA, CPHQ, FACEP (University of South Florida), Adam L. Sharp, MD, MSc (Kaiser Permanente)
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- EMBED Trial: Clinical Decision Support for OUD in the ED (Part 1) – Ted Melnick, MD, MHS, Yale School of Medicine
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- EMBED Trial: Clinical Decision Support for OUD in the ED (Part 2) – Jason Hoppe, DO, FACEP, University of Colorado School of Medicine)
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- MATTERS Network: Medication for Addiction Treatment and Electronic Referrals – Joshua Lynch, DO, EMT-P, FAAEM, FACEP, University at Buffalo
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- U.S. Acute Care Settings – Arianna Campbell, PA-C (California Bridge) and Jesse Pines, MD (US Acute Care Solutions)
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- American College of Emergency Physicians Clinical Emergency Data Registry – Pawan Goyal, MD, MHA, ACEP
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- Quality Improvement for Care of OUD in Community EDs: The Vituity Experience – Bradford Tinloy, MD, FACEP, FAAEM, Vituity
- ED-Initiated Buprenorphine: Economic Considerations – Sean Murphy, PhD (CHERISH, Weill Cornell Medicine)
Tobacco, alcohol, and drug use are leading causes of preventable death in the U.S. and screening for alcohol and drug use in primary care is recommended. However, such screening has not become part of routine health care, and substance use information is not systematically collected in electronic health records. This presentation describes the objectives, methods, and outcomes of CTN-0062-Ot, a phased feasibility and proof-of-concept study seeking to incorporate addiction-specific screening and assessment common data elements into a widely used EHR.
Related protocols: CTN-0062-Ot
Tobacco, alcohol, and drug use are leading causes of preventable death in the U.S., but screening for alcohol and drug use is not part of routine health care and substance use information is not systematically collected in electronic health records.
This presentation described two protocols in the CTN that aimed to address this issue: CTN-0059, in which the TAPS Tool for screening and brief assessment was developed and validated, and CTN-0062, a feasibility and proof-of-concept study to assess incorporating the NIDA CTN Common Data Elements into electronic health records in large primary care settings.
Related protocols: CTN-0059, CTN-0062-Ot
Alcohol and drug use are significant drivers of preventable morbidity and mortality that are not routinely identified or treated in medical settings. Screening, brief intervention, and referral to treatment (SBIRT) to address substance use in primary care is widely promoted, but has proven challenging to implement. Validated screening tools that can quickly and accurately identify substance use have been designated common data elements (CDEs), but are not widely integrated into electronic health records (EHRs). As part of a study of the NIDA Clinical Trials Network (CTN-0062-Ot), a clinical decision support system (CDSS) was developed to support the delivery of substance use screening and interventions in primary care.
This presentation reports on usability testing performed to address the challenges of developing the CDSS. Usability testing identified important issues related to workflow and content, as well as human-computer interactions problems. An iterative process of usability testing and content adaptation allowed researchers to successfully modify a commercial EHR for delivery of a complex behavioral intervention, though some limitations to its functionality remain. Future phases of this study will examine adoption of this CDSS in multiple primary care clinics.
Related protocols: CTN-0062-Ot
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization created by the Affordable Care Act in March 2010 that funds comparative effective research to answer important real life questions. In 2014, the PCORI Advisory Panel on Assessment of Prevention, Diagnosis, and Treatment Options prioritized 14 new research topics, including Treatment Options for Substance Abuse.
The National Drug Abuse Treatment Clinical Trials Network (CTN) sponsored this workshop for all NIDA investigators interested in learning how to apply for PCORI funding. It was also broadcast via webinar to remote participants. The workshop was co-chaired by Betty Tai, Director, CCTN and Redonna Chandler, Acting Director, DESPR. The goal of the workshop was to provide technical assistance to NIDA grantees regarding PCORI funding opportunities, given that PCORI identified treatment options for opioid substance abuse as a high-priority research topic, and that their funding process is different from the NIH process. The agenda included a presentation from PCORI staff summarizing PCORI’s objectives, priorities, available funding, and application process. NIDA researchers discussed the state of the science regarding opioid substance abuse and presented experiences with the PCORI funding/review process. Presenters included: Dr. Joe Selby and Dr. David Hickam, PCORI, Dr. Walter Ling, UCLA, Dr. Adam Brooks, TRI, Dr. Cynthia Campbell, Kaiser Permanente, and Dr. Jay Ford, Univ. of Wisconsin.
View the workshop agenda and speaker bios. Slides from the presentations are available below. (Additional PCORI-related resources are available in the sidebar to the right.)
Overview of PCORI — David Hickam, MD, MPH; Bryan Luce, PhD, MS, MBA; Joe V. Selby, MD, MPH.
Opportunities to Test Effective Opiate Treatments — Walter Ling, MD
Engaging Patients and Clinicians to Improve Patient-Centered Treatment Outcome: Stakeholders’ Substance Use Research and Treatment Information Exchange — Walter Ling, MD
Prescription Opioid Management in Chronic Pain Patients: A Patient-Centered Activation Intervention — Cynthia Campbell, PhD, MPH
Review Experience — Jay Ford, PhD
This session presented information about the CTN Public Data Share website (now called the NIDA Data Share website), an electronic environment that allows data from completed clinical trials to be distributed to investigators and the public in order to promote new research, encourage further analyses, and disseminate information to the community. Secondary analyses produced from data sharing multiply the scientific contribution of the original research, optimizing the use of resources invested in the trials, as well as increasing scientific productivity.
Presentations in the session described the methods and results of secondary analyses conducted using the datasets, as well as the value of conducting secondary analyses to advance knowledge of evidence-based treatments.
Speakers included:
Overview of CTN Datashare – Carmen Rosa, MS, CCTN, NIDA
Practical Approaches for Using the CTN Datashare: Proposing Parameters, Creating Data Tables, and Analyzing Results – Abigail G. Matthews, PhD, the EMMES Corporation
Using the CTN Datashare: An Example Utilizing Data from Multiple Protocols – Audrey J. Brooks, PhD, University of Arizona
Secondary Analyses: Value and Limitations – Daniel J. Feaster, PhD, University of Miami Miller School of Medicine
The purpose of this study was to examine sensitivity to missing data procedures on treatment effects in a randomized controlled trial (RCT) of osmotic-release methylphenidate (OROS) for adolescents with co-occurring attention-deficit/hyperactivity disorder (ADHD) and substance use disorders (SUD). Data came from a National Drug Abuse Treatment Clinical Trials Network study (CTN-0028, N=303), which evaluated the safety/efficacy of a 16-week RCT of OROS vs. placebo in adolescents aged 13-18 with ADHD who were also receiving cognitive-behavioral therapy for their SUD. The two primary outcomes were clinician-reported ADHD symptoms and self-reported past 28 days of substance use (SU). A parallel grow model was used to assess the effect sizes assuming missing at random (MAR) compared to two missing not at random (MNAR) models: Diggle-Kenward (DK) selection model and Wu-Carroll (WC) selection model.
The MAR model found no significant treatment effect on ADHD or SU, and the effect sizes were small for both ADHD and SU. The MNAR DK model also produced non-significant treatment effects with similar effect sizes of ADHD and SU. The MNAR WC model evidenced a significant effect of OROS relative to placebo on SU, and the effect sizes for both ADHD and SU were larger than reported in the other models.
Conclusions: While the MAR model and one MNAR model found similarly sized effects as the original RCT, the second MNAR model produced different results for both of the outcomes. This sensitivity analysis highlights an important need for future RCTs of co-morbid mental illness and SUDs to carefully evaluate the missing data assumptions made when assessing treatment effects.
Related protocols: CTN-0028
This presentation reports on a National Drug Abuse Treatment Clinical Trials Network (CTN) study that aimed to evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence (CTN-0052). This randomized, double-blind, placebo-controlled, 16-week pilot trials was conducted at 6 clinical sites. Adults meeting DSM-IV-TR criteria for current cocaine dependence scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized, and planning to enroll in local outpatient treatment through the end of the active treatment phase, were randomized to buspirone titrated to 60 mg/day (n=35) or to placebo (n=27). All participants received psychosocial treatment as usually provided by the SUD treatment programs in which they were enrolled. Outcome measures included maximum days of continuous cocaine abstinence (primary), proportion of cocaine use days, and days-to-first-cocaine-use during the outpatient treatment phase (study weeks 4-15) as assessed by self-report and urine drug screens.
Study retention was high, with a 94% completion rate, and medication adherence was also strong (85% based on medication events monitoring system). However, there were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use. Additionally, buspirone, relative to placebo, actually increased the proportion of cocaine use days in female participants, though not in males.
Conclusions: These results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and may even worsen cocaine use outcomes for women.
Related protocols: CTN-0052
This symposium presented findings from the National Drug Abuse Treatment Clinical Trials Network focused on gender differences in four different studies: Stimulant Abuser Groups to Engage in 12-Step (STAGE-12, CTN-0031); Web Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders (CTN-0044); Screening, Motivational Assessment, Referral and Treatment in Emergency Departments (SMART-ED, CTN-0047); and Stimulant Reduction Intervention Using Dosed Exercise (STRIDE, CTN-0037).
Presentations included:
Elizabeth A. Wells, PhD, University of Washington
Gender Differences in Response to a 12 Step Engagement Intervention.
Aimee N.C. Campbell, PhD, MSW, Columbia University in the City of New York
Gender Differences in Acceptability and Treatment Outcomes of a Web Based Psychosocial Intervention.
Audrey Brooks, PhD, University of Arizona
Gender Differences in Treatment Access and Outcome Following an ED SBIRT Intervention.
Therese K. Killeen, PhD, Medical University of South Carolina
Stimulant Reduction Intervention Using Dosed Exercise: Gender Differences/Treatment Acceptability.
Discussant: Shelly F. Greenfield, MD, MPH, Harvard Medical School
Related protocols: CTN-0031, CTN-0037, CTN-0044, CTN-0047