Leveraging Project ECHO to Implement a Suite of Substance Use Learning Communities for Statewide Impact.

BACKGROUND: Overdoses and alcohol consumption rose during the pandemic. However, uptake of practices which reduce mortality (eg, medications for opioid use disorder, harm reduction practices) remains insufficient. Provider training and telementoring is needed to ensure sufficient capacity for treating substance use disorders (SUDs) with evidence-based practices. The Project ECHO (Extension for Community Healthcare Outcomes) model involves the use of web technologies to deliver didactic and case-based learning through a panel of experts to build such competency in a community of learners. Project ECHO was leveraged to implement a statewide telementoring center of addictions-focused ECHO programs, including programming in prescribing, harm reduction, recovery support services, collaborations with first responders, and systems-level challenges. METHODS: Participants represented health and behavioral health disciplines practicing across the state of Texas in metropolitan and rural areas. Learners were administered: (1) an online registration form that inquired about basic demographics, (2) a post-session survey at the conclusion of each session capturing satisfaction and likelihood to implement, and (3) annual surveys measuring changes in knowledge and self-efficacy. Attendance and other learner data were stored and extracted from the partner relationship management database: iECHO. RESULTS: Training programs were attended by 968 learners, with an average of 48 learners per session. Geographic reach included 47 Texas cities. Post-training survey results indicated high rates of learner satisfaction, with an average rating of 4.68 on a 5-point Likert-like scale. Annual surveys indicated improvements in provider knowledge and self-confidence across all programs. CONCLUSIONS: Early results indicate robust uptake, wide geographic reach, high learner satisfaction, and provider knowledge and confidence gains. This preliminary evidence supports the use of the ECHO model as a potential tool for scaling comprehensive SUD telementoring centers to meet workforce development needs over large geographic areas.

Stigma towards opioid use disorder in primary care remain a barrier to integrating software-based measurement based care.

BACKGROUND: Opioid use disorder (OUD) is a deadly illness that remains undertreated, despite effective pharmacological treatments. Barriers, such as stigma, treatment affordability, and a lack of training and prescribing within medical practices result in low access to treatment. Software-delivered measurement-based care (MBC) is one way to increase treatment access. MBC uses systematic patient symptom assessments to inform an algorithm to support clinicians at critical decision points. METHOD: Focus groups of faculty clinicians (N = 33) from 3 clinics were conducted to understand perceptions of OUD diagnosis and treatment and whether a computerized MBC model might assist with diagnosis and treatment. Themes from the transcribed focus groups were identified in two phases: (1) content analysis focused on uncovering general themes; and (2) systematic coding and interpretation of the data. RESULTS: Analysis revealed six major themes utilized to develop the coding terms: "distinguishing between chronic pain and OUD," "current practices with patients using prescribed or illicit opioids or other drugs," "attitudes and mindsets about providing screening or treatment for OUD in your practice," "perceived resources needed for treating OUD," "primary care physician role in patient care not specific to OUD," and "reactions to implementation of proposed clinical decision support tool." CONCLUSION: Results revealed that systemic and attitudinal barriers to screening, diagnosing, and treating OUD continue to persist. Providers tended to view the software-based MBC program favorably, indicating that it may be a solution to increasing accessibility to OUD treatment; however, further interventions to combat stigma would likely be needed prior to implementation of these programs. TRIAL REGISTRATION: ClinicalTrials.gov; NCT04059016; 16 August 2019; retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT04059016 .

Addressing chronic pain with Focused Acceptance and Commitment Therapy in integrated primary care: findings from a mixed methods pilot randomized controlled trial.

BACKGROUND: Over 100 million Americans have chronic pain and most obtain their treatment in primary care clinics. However, evidence-based behavioral treatments targeting pain-related disability are not typically provided in these settings. Therefore, this study sought to: 1) evaluate implementation of a brief evidence-based treatment, Focused Acceptance and Commitment Therapy (FACT-CP), delivered by an integrated behavioral health consultant (BHC) in primary care; and 2) preliminarily explore primary (self-reported physical disability) and secondary treatment outcomes (chronic pain acceptance and engagement in valued activities). METHODS: This mixed-methods pilot randomized controlled trial included twenty-six participants with non-cancer chronic pain being treated in primary care (54% women; 46% Hispanic/Latino). Active participants completed a 30-min individual FACT-CP visit followed by 3 weekly 60-min group visits and a booster visit 2 months later. An enhanced treatment as usual (ETAU) control group received 4 handouts about pain management based in cognitive-behavioral science. Follow-up research visits occurred during and after treatment, at 12 weeks (booster visit), and at 6 months. Semi-structured interviews were conducted to collect qualitative data after the last research visit. General linear mixed regression models with repeated measures explored primary and secondary outcomes. RESULTS: The study design and FACT-CP intervention were feasible and acceptable. Quantitative analyses indicate at 6-month follow-up, self-reported physical disability significantly improved pre-post within the FACT-CP arm (d = 0.64); engagement in valued activities significantly improved within both the FACT-CP (d = 0.70) and ETAU arms (d = 0.51); and chronic pain acceptance was the only outcome significantly different between arms (d = 1.04), increased in the FACT-CP arm and decreased in the ETAU arm. Qualitative data analyses reflected that FACT-CP participants reported acquiring skills for learning to live with pain, consistent with increased chronic pain acceptance. CONCLUSION: Findings support that FACT-CP was acceptable for patients with chronic pain and feasible for delivery in a primary care setting by a BHC. Results provide preliminary evidence for improved physical functioning after FACT-CP treatment. A larger pragmatic trial is warranted, with a design based on data gathered in this pilot. TRIAL REGISTRATION: clinicaltrials.gov, NCT04978961 (27/07/2021).

Confronting challenges to opioid risk mitigation in the U.S. health system: Recommendations from a panel of national experts.

BACKGROUND: Amid the ongoing U.S. opioid crisis, achieving safe and effective chronic pain management while reducing opioid-related morbidity and mortality is likely to require multi-level efforts across health systems, including the Military Health System (MHS), Department of Veterans Affairs (VA), and civilian sectors. OBJECTIVE: We conducted a series of qualitative panel discussions with national experts to identify core challenges and elicit recommendations toward improving the safety of opioid prescribing in the U.S. DESIGN: We invited national experts to participate in qualitative panel discussions regarding challenges in opioid risk mitigation and how best to support providers in delivery of safe and effective opioid prescribing across MHS, VA, and civilian health systems. PARTICIPANTS: Eighteen experts representing primary care, emergency medicine, psychology, pharmacy, and public health/policy participated. APPROACH: Six qualitative panel discussions were conducted via teleconference with experts. Transcripts were coded using team-based qualitative content analysis to identify key challenges and recommendations in opioid risk mitigation. KEY RESULTS: Panelists provided insight into challenges across multiple levels of the U.S. health system, including the technical complexity of treating chronic pain, the fraught national climate around opioids, the need to integrate surveillance data across a fragmented U.S. health system, a lack of access to non-pharmacological options for chronic pain care, and difficulties in provider and patient communication. Participating experts identified recommendations for multi-level change efforts spanning policy, research, education, and the organization of healthcare delivery. CONCLUSIONS: Reducing opioid risk while ensuring safe and effective pain management, according to participating experts, is likely to require multi-level efforts spanning military, veteran, and civilian health systems. Efforts to implement risk mitigation strategies at the patient level should be accompanied by efforts to increase education for patients and providers, increase access to non-pharmacological pain care, and support use of existing clinical decision support, including state-level prescription drug monitoring programs.

Quality of life among women diagnosed with breast Cancer: A randomized waitlist controlled trial of commercially available mobile app-delivered mindfulness training.

OBJECTIVE: The primary objective was to evaluate the efficacy of commercially available mobile app-delivered mindfulness training (AMT), compared with waitlist control (WC), on quality of life (QOL) among women diagnosed with breast cancer. The secondary outcome was dispositional mindfulness. Enrollment, app utilization, and study completion are reported as feasibility objectives. METHODS: Women diagnosed with breast cancer ≤5 years (n = 112) were randomized to AMT (n = 57) or WC (n = 55), over 8 weeks, with 4 weeks of follow-up. We conducted linear mixed effects models to examine group by observation interactions on QOL and dispositional mindfulness at baseline, during intervention (5-weeks), post-intervention (9-weeks), and follow-up (12-weeks post-baseline). RESULTS: Participants assigned to AMT reported higher QOL, compared with those assigned to WC, from baseline through follow-up t(258.40) = 3.09, P < 0.01, 95% CI [2.71, 11.90]. Participants assigned to AMT also reported higher dispositional mindfulness, compared with those assigned to WC, from baseline through follow-up t(268.44) = 2.04, P = 0.04, 95% CI [0.01, 0.57]. App utilization data was obtained from 34 participants. Fewer participants assigned to AMT completed all study assessments, compared with participants assigned to WC, (χ21  = 7.07, P = 0.008). CONCLUSIONS: Findings suggest commercially available AMT may proffer some benefit to women seeking to enhance their QOL following breast cancer diagnosis.

Rationale and design of a pilot study examining Acceptance and Commitment Therapy for persistent pain in an integrated primary care clinic.

Most of the 100 million Americans with persistent pain are treated in primary care clinics, but evidence-based psychosocial approaches targeting pain-related disability are not usually provided in these settings. This manuscript describes the rationale and methods for a protocol to pilot test the feasibility and effectiveness of Acceptance and Commitment Therapy (ACT), an evidence-based psychological treatment for persistent pain, delivered by a Behavioral Health Consultant in primary care. Eligible patients are identified through electronic health record registries and invited to participate via secure messaging, letters and a follow-up phone call. Participants are also recruited with advertising and clinician referral. Patients agreeing to participate are consented and complete initial assessments, with a target of 60 participants. Randomization is stratified based on pain severity with participants assigned to either ACT or Enhanced Treatment as Usual (E-TAU). ACT participants receive one standardized Behavioral Health Consultation visit followed by three ACT-based group visits and one group booster visit. All patients attend six assessment visits, during which the E-TAU patients are provided with educational pain management handouts based on standard cognitive behavioral treatment of pain. The study aims to determine feasibility and effectiveness of brief ACT for persistent pain delivered by an integrated behavioral health clinician in primary care from pre- to post-treatment, and to examine mechanisms of change in ACT participants. This study, in a "real-world" setting, will lay groundwork for a larger trial. If effective, it could improve treatment methods and quality of life for patients with persistent pain using a scalable approach.

Evaluating the impact of prescription drug monitoring program implementation: a scoping review.

BACKGROUND: Prescription drug monitoring programs (PDMPs) have been implemented in 49 out of 50 states in an effort to reduce opioid-related misuse, abuse, and mortality, yet the literature evaluating the impact of PDMP implementation remains limited. We conducted a scoping review to: (1) describe available evidence regarding impact of PDMPs in the U.S.; and (2) propose a conceptual model to inform future PDMP implementation and evaluation efforts. METHODS: Scoping systematic review following Arksey and O'Malley's (2005) methodology. We identified 11 relevant studies based on inclusion criteria using a PubMed database search of English-language studies published 1/1/2000-5/31/16. Data were extracted and thematic analysis conducted to synthesize results. RESULTS: Extant evidence for the impact of PDMPs as an opioid risk mitigation tool remains mixed. Thematic analysis revealed four domains of opioid-related outcomes frequently examined in original studies evaluating PDMP implementation: (1) opioid prescribing; (2) opioid diversion and supply; (3) opioid misuse; and (4) opioid-related morbidity and mortality. An evaluation framework incorporating these domains is presented that highlights significant gaps in empirical research across each of these domains. CONCLUSIONS: Evidence for the impact of state-level PDMPs remains mixed. We propose a conceptual model for evaluating PDMP implementation toward the goals of clarifying PDMP mechanisms of impact, identifying characteristics of PDMPs associated with best outcomes, and maximizing the utility of PDMP policy and implementation to reduce opioid-related public health burden.

Long-term outcomes from the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study.

BACKGROUND: Despite the growing prevalence of prescription opioid dependence, longitudinal studies have not examined long-term treatment response. The current study examined outcomes over 42 months in the Prescription Opioid Addiction Treatment Study (POATS). METHODS: POATS was a multi-site clinical trial lasting up to 9 months, examining different durations of buprenorphine-naloxone plus standard medical management for prescription opioid dependence, with participants randomized to receive or not receive additional opioid drug counseling. A subset of participants (N=375 of 653) enrolled in a follow-up study. Telephone interviews were administered approximately 18, 30, and 42 months after main-trial enrollment. Comparison of baseline characteristics by follow-up participation suggested few differences. RESULTS: At Month 42, much improvement was seen: 31.7% were abstinent from opioids and not on agonist therapy; 29.4% were receiving opioid agonist therapy, but met no symptom criteria for current opioid dependence; 7.5% were using illicit opioids while on agonist therapy; and the remaining 31.4% were using opioids without agonist therapy. Participants reporting a lifetime history of heroin use at baseline were more likely to meet DSM-IV criteria for opioid dependence at Month 42 (OR=4.56, 95% CI=1.29-16.04, p<.05). Engagement in agonist therapy was associated with a greater likelihood of illicit-opioid abstinence. Eight percent (n=27/338) used heroin for the first time during follow-up; 10.1% reported first-time injection heroin use. CONCLUSIONS: Long-term outcomes for those dependent on prescription opioids demonstrated clear improvement from baseline. However, a subset exhibited a worsening course, by initiating heroin use and/or injection opioid use.

The multi-site prescription opioid addiction treatment study: 18-month outcomes.

Despite the high prevalence of prescription opioid dependence in the U.S., little is known about the course of this disorder and long-term response to treatment. We therefore examined 18-month post-randomization outcomes of participants in the Prescription Opioid Addiction Treatment Study, a multi-site, randomized controlled trial examining varying durations of buprenorphine-naloxone treatment and different intensities of counseling for prescription opioid dependence. Thus the current follow-up study provides a unique contribution to the field by reporting longer-term outcomes of a well-characterized population of treatment-seeking prescription opioid dependent patients. Participants from the treatment trial (N=252/653) completed an 18-month follow-up telephone assessment. Multivariable analyses examined associations between participant characteristics and key indicators of month-18 status: opioid abstinence, DSM-IV opioid dependence, and opioid agonist treatment. Overall, participants showed improvement from baseline to month 18: 49.6% were abstinent in the previous 30 days, with only 16.3% opioid-dependent. Some participants, however, had initiated past-year heroin use (n=9) or opioid injection (n=17). Most participants (65.9%) engaged in substance use disorder treatment during the past year, most commonly opioid agonist therapy (48.8%). Of particular interest in this population, multivariable analysis showed that greater pain severity at baseline was associated with opioid dependence at 18 months. In conclusion, although opioid use outcomes during the treatment trial were poor immediately following a buprenorphine-naloxone taper compared to those during 12 weeks of buprenorphine-naloxone stabilization, opioid use outcomes at 18-month follow-up showed substantial improvement over baseline and were comparable to the rate of successful outcomes during buprenorphine-naloxone stabilization in the treatment trial.

Who benefits from additional drug counseling among prescription opioid-dependent patients receiving buprenorphine-naloxone and standard medical management?

BACKGROUND: In the multi-site Prescription Opioid Addiction Treatment Study (POATS), conducted within the National Drug Abuse Clinical Trials Network, participants randomly assigned to receive individual drug counseling in addition to buprenorphine-naloxone and medical management did not have superior opioid use outcomes. However, research with other substance-dependent populations shows that subgroups of participants may benefit from a treatment although the entire population does not. METHOD: We conducted a secondary analysis of POATS data to determine whether a subgroup of participants benefited from drug counseling in addition to buprenorphine-naloxone and medical management, either due to greater problem severity or more exposure to counseling as a result of greater treatment adherence. Problem severity was measured by a history of heroin use, higher Addiction Severity Index drug composite score, and chronic pain. Adequate treatment adherence was defined a priori as attending at least 60% of all offered sessions. RESULTS: Patients who had ever used heroin and received drug counseling were more likely to be successful (i.e., abstinent or nearly abstinent from opioids) than heroin users who received medical management alone, but only if they were adherent to treatment and thus received adequate exposure to counseling (OR=3.7, 95% CI=1.1-11.8, p=0.03). The association between severity and outcome did not vary by treatment condition for chronic pain or ASI drug severity score. CONCLUSIONS: These findings emphasize the importance of treatment adherence, and suggest that patients with prescription opioid dependence are a heterogeneous group, with different optimal treatment strategies for different subgroups.

Reasons for opioid use among patients with dependence on prescription opioids: the role of chronic pain.

The number of individuals seeking treatment for prescription opioid dependence has increased dramatically, fostering a need for research on this population. The aim of this study was to examine reasons for prescription opioid use among 653 participants with and without chronic pain, enrolled in the Prescription Opioid Addiction Treatment Study, a randomized controlled trial of treatment for prescription opioid dependence. Participants identified initial and current reasons for opioid use. Participants with chronic pain were more likely to report pain as their primary initial reason for use; avoiding withdrawal was rated as the most important reason for current use in both groups. Participants with chronic pain rated using opioids to cope with physical pain as more important, and using opioids in response to social interactions and craving as less important, than those without chronic pain. Results highlight the importance of physical pain as a reason for opioid use among patients with chronic pain.

Impulsivity but not sensation seeking is associated with opioid analgesic misuse risk in patients with chronic pain.

Impulsivity and sensation seeking have been associated with substance use disorders, including opioid use disorders. This pilot study sought to examine whether impulsivity and sensation seeking, as measured by the Barratt Impulsiveness Scale (BIS) and Sensation Seeking Scale (SSS), were associated with opioid analgesic misuse risk in chronic, low-back pain patients prescribed opioid analgesics. Participants were 42 chronic, low-back pain patients enrolled in a larger study examining problematic opioid analgesic use. Impulsivity was assessed using the BIS, sensation seeking was measured using the SSS, and opioid analgesic misuse risk was assessed using the Current Opioid Misuse Measure (COMM). Significant bivariate associations were found between the COMM and the following predictor variables: age and the three BIS subscales: Attentional Impulsiveness, Non-planning Impulsiveness, and Motor Impulsiveness. Using a multivariate linear regression, after controlling for age, the BIS subscales accounted for 29.0% of the variance in the COMM. Attentional Impulsiveness was the only significant BIS subscale. These results suggest a potential relationship between impulsivity, but not sensation seeking, and risk for opioid analgesic misuse. Impulsivity is not a prominent trait observed in chronic pain patients; however, it may be an important risk factor for opioid analgesic misuse for a subset of individuals with chronic pain. As such, these findings suggest that additional exploration of this potential risk factor is warranted.

Racial/ethnic differences in the rates and correlates of HIV risk behaviors among drug abusers.

BACKGROUND: HIV infection disproportionately impacts minorities; yet research on racial/ethnic differences in the prevalence and correlates of HIV risk behaviors is limited. OBJECTIVE: This study examined racial/ethnic differences in the rates of HIV risk behaviors and whether the relationship between HIV risk factors and HIV risk behaviors varies by race/ethnicity in clients participating in NIDA Clinical Trials Network trials. RESULTS: The sample was 41% non-Hispanic White, 32% non-Hispanic Black, and 27% Hispanic (N = 2,063). HIV risk behaviors and measures of substance and psychosocial HIV risk factors in the past month were obtained. Non-Hispanic Blacks engaged in less HIV sexual risk behaviors overall than non-Hispanic Whites. While non-Hispanic Whites were the most likely to report any injection drug use, Hispanics engaged in the most HIV drug risk behaviors. Specific risk factors were differentially predictive of HIV risk behavior by race/ethnicity. Alcohol use severity was related to engaging in higher sex risk behaviors for non-Hispanic Blacks and Whites. Greater psychiatric severity was related to engaging in higher sex risk behaviors for non-Hispanic Whites. Drug use severity was associated with engaging in higher risk drug behaviors for non-Hispanic Whites and Hispanics with the magnitude of the relationship stronger for Hispanics. CONCLUSIONS: These findings highlight the need for further research testing HIV risk prevention interventions within racial/ethnic groups to identify target behaviors or risk factors that are salient to inform HIV interventions. SCIENTIFIC SIGNIFICANCE: The present study provides a systematic examination of race/ethnicity differences in the relationship between psychosocial risk factors and HIV risk behaviors.

Gender differences in a clinical trial for prescription opioid dependence.

Although gender differences in substance use disorders have been identified, few studies have examined gender differences in prescription drug dependence. The aim of this study was to examine gender differences in clinical characteristics and treatment outcomes in a large clinical trial for prescription opioid dependence. Despite no pre-treatment differences in opioid dependence severity, women reported significantly greater functional impairment, greater psychiatric severity, and higher likelihood of using opioids to cope with negative affect and pain than men. Women were also more likely than men to have first obtained opioids via a legitimate prescription and to use opioids via the intended route of administration. Men reported significantly more alcohol problems than women. There were no significant gender differences in medication dose, treatment retention, or opioid outcomes. Thus, despite the presence of pre-treatment gender differences in this population, once the study treatment was initiated, women and men exhibited similar opioid use outcomes.

Patient characteristics associated with buprenorphine/naloxone treatment outcome for prescription opioid dependence: Results from a multisite study.

BACKGROUND: Prescription opioid dependence is a growing problem, but little research exists on its treatment, including patient characteristics that predict treatment outcome. METHODS: A secondary analysis of data from a large multisite, randomized clinical trial, the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study (POATS) was undertaken to examine baseline patient characteristics (N=360) associated with success during 12-week buprenorphine/naloxone treatment for prescription opioid dependence. Baseline predictor variables included self-reported demographic and opioid use history information, diagnoses assessed via the Composite International Diagnostic Interview, and historical opioid use and related information from the Pain And Opiate Analgesic Use History. RESULTS: In bivariate analyses, pre-treatment characteristics associated with successful opioid use outcome included older age, past-year or lifetime diagnosis of major depressive disorder, initially obtaining opioids with a medical prescription to relieve pain, having only used opioids by swallowing or sublingual administration, never having used heroin, using an opioid other than extended-release oxycodone most frequently, and no prior opioid dependence treatment. In multivariate analysis, age, lifetime major depressive disorder, having only used opioids by swallowing or sublingual administration, and receiving no prior opioid dependence treatment remained as significant predictors of successful outcome. CONCLUSIONS: This is the first study to examine characteristics associated with treatment outcome in patients dependent exclusively on prescription opioids. Characteristics associated with successful outcome after 12 weeks of buprenorphine/naloxone treatment include some that have previously been found to predict heroin-dependent patients' response to methadone treatment and some specific to prescription opioid-dependent patients receiving buprenorphine/naloxone.

Randomized multi-site trial of the Job Seekers' Workshop in patients with substance use disorders.

BACKGROUND: Unemployment is associated with negative outcomes both during and after drug abuse treatment. Interventions designed to increase rates of employment may also improve drug abuse treatment outcomes. The purpose of this multi-site clinical trial was to evaluate the Job Seekers' Workshop (JSW), a three session, manualized program designed to train patients in the skills needed to find and secure a job. METHOD: Study participants were recruited through the NIDA Clinical Trials Network (CTN) from six psychosocial counseling (n=327) and five methadone maintenance (n=301) drug treatment programs. Participants were randomly assigned to either standard care (program-specific services plus brochure with local employment resources) (SC) or standard care plus JSW. Three 4-h small group JSW sessions were offered weekly by trained JSW facilitators with ongoing fidelity monitoring. RESULTS: JSW and SC participants had similar 12- and 24-week results for the primary outcome measure (i.e., obtaining a new taxed job or enrollment in a training program). Specifically, one-fifth of participants at 12weeks (20.1-24.3%) and nearly one-third at 24 weeks (31.4-31.9%) had positive outcomes, with "obtaining a new taxed job" accounting for the majority of cases. CONCLUSION: JSW group participants did not have higher rates of employment/training than SC controls. Rates of job acquisition were modest for both groups, suggesting more intensive interventions may be needed. Alternate targets (e.g., enhancing patient motivation, training in job-specific skills) warrant further study as well.

Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence: a 2-phase randomized controlled trial.

CONTEXT: No randomized trials have examined treatments for prescription opioid dependence, despite its increasing prevalence. OBJECTIVE: To evaluate the efficacy of brief and extended buprenorphine hydrochloride-naloxone hydrochloride treatment, with different counseling intensities, for patients dependent on prescription opioids. DESIGN: Multisite, randomized clinical trial using a 2-phase adaptive treatment research design. Brief treatment (phase 1) included 2-week buprenorphine-naloxone stabilization, 2-week taper, and 8-week postmedication follow-up. Patients with successful opioid use outcomes exited the study; unsuccessful patients entered phase 2: extended (12-week) buprenorphine-naloxone treatment, 4-week taper, and 8-week postmedication follow-up. SETTING: Ten US sites. Patients A total of 653 treatment-seeking outpatients dependent on prescription opioids. INTERVENTIONS: In both phases, patients were randomized to standard medical management (SMM) or SMM plus opioid dependence counseling; all received buprenorphine-naloxone. MAIN OUTCOME MEASURES: Predefined "successful outcome" in each phase: composite measures indicating minimal or no opioid use based on urine test-confirmed self-reports. RESULTS: During phase 1, only 6.6% (43 of 653) of patients had successful outcomes, with no difference between SMM and SMM plus opioid dependence counseling. In contrast, 49.2% (177 of 360) attained successful outcomes in phase 2 during extended buprenorphine-naloxone treatment (week 12), with no difference between counseling conditions. Success rates 8 weeks after completing the buprenorphine-naloxone taper (phase 2, week 24) dropped to 8.6% (31 of 360), again with no counseling difference. In secondary analyses, successful phase 2 outcomes were more common while taking buprenorphine-naloxone than 8 weeks after taper (49.2% [177 of 360] vs 8.6% [31 of 360], P < .001). Chronic pain did not affect opioid use outcomes; a history of ever using heroin was associated with lower phase 2 success rates while taking buprenorphine-naloxone. CONCLUSIONS: Prescription opioid-dependent patients are most likely to reduce opioid use during buprenorphine-naloxone treatment; if tapered off buprenorphine-naloxone, even after 12 weeks of treatment, the likelihood of an unsuccessful outcome is high, even in patients receiving counseling in addition to SMM.

Determining the primary endpoint for a stimulant abuse trial: lessons learned from STRIDE (CTN 0037).

BACKGROUND: No consensus is available for identifying the best primary outcome for substance use disorder trials, making interpretation across trials difficult. Abstinence is the most desirable treatment outcome although a wide variety of other endpoints have been used. OBJECTIVES: This report provides a framework for determining an optimal primary endpoint and the relevant measurement approach for substance use disorder treatment trials. The framework was developed based on a trial for stimulant abuse using exercise as an augmentation treatment, delivered within the NIDA Clinical Trials Network. The use of a common endpoint across trials will facilitate comparisons of treatment efficacy. METHODS: Primary endpoint options in existing substance abuse studies were evaluated. This evaluation included surveys of the literature for endpoints and measurement approaches, followed by assessment of endpoint choices against study design issues, population characteristics, tests of sensitivity, and tests of clinical meaningfulness. CONCLUSION: We concluded that the best current choice for a primary endpoint is percent days abstinent, as measured by the Time Line Follow Back interview conducted three times a week with recall aided by a take-home Substance Use Diary. To improve the accuracy of the self-reported drug use, the results of qualitative urine drug screens will be used in conjunction with the Time Line Follow Back results. SCIENTIFIC SIGNIFICANCE: There is a need for a standardized endpoint in this field to allow for comparison across treatment studies, and we suggest that the recommended candidate endpoint be considered. However, the study design and goals ultimately must guide the final decision.

Site selection in community-based clinical trials for substance use disorders: strategies for effective site selection.

BACKGROUND: The importance of conducting substance use disorder treatment research in real-world settings is now well recognized. While this approach to clinical trials research offers a variety of benefits, challenges also arise. Selecting high-quality sites to participate is critical to recruitment, retention, and overall trial performance when conducting multi-site, community-based clinical trials of treatments for substance use disorders. OBJECTIVES: Over the past 10 years, the National Institute on Drug Abuse-sponsored National Drug Abuse Treatment Clinical Trials Network (CTN) has strived to conduct high-quality, well-managed clinical trials. This includes developing methods for site selection to be used by investigators conducting CTN trials. METHODS: We review site selection strategies from two community-based multi-site clinical trials conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network. RESULTS: Issues relevant to site selection include the clinical trial design, availability of appropriate clinical population, and organizational attributes of potential clinical research sites. Site selection strategies include reviewing regional epidemiologic data, collecting standard site selection surveys, evaluating clinic data on existing patient populations, and site selection interviews and visits. CONCLUSION: This article describes considerations for selecting research sites and identifies specific strategies to employ when selecting community-based sites for participation in clinical trials.