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Abstract: As overdose rates rise among non-White Americans, understanding barriers to substance use disorder (SUD) treatment access by race and ethnicity is important. This study explores self-reported barriers to SUD treatment by race and ethnicity in emergency department (ED) populations. We conducted a secondary, exploratory analysis of a randomized trial of patients not seeking SUD treatment who endorsed active drug use at six academic EDs (CTN-0047). Responses to the Barriers to Treatment Inventory were compared by race, ethnicity, and drug severity, using 2 tests (N = 858), followed by adjusted logistic regression models. Absence of a perceived drug problem (39% non-Hispanic Black, 38% Hispanic, 50% non-Hispanic White; p = .001) was the most prevalent barrier to SUD treatment. Non-Hispanic Black participants were less likely to state that they could handle their drug use on their own (OR = 0.69, CI = 0.50-0.95), and were more likely to report disliking personal questions than non-Hispanic White participants (OR = 1.49, CI = 1.07-2.09). Non-Hispanic Black participants were less likely than Hispanic participants to agree that treatment availability (OR = 0.46, CI = 0.28-0.76) and family disapproval (OR = 0.38, CI = 0.16-0.91) were treatment barriers. Conclusions: Screening and counseling may help address the barrier, common to all groups, that drug use was not seen as problematic. Expanding access to diverse treatment options may also address the range of barriers reported by our study population. This study is one of the first in the U.S. to examine both individual and structural barriers to accessing treatment and to examine the association with drug use severity by race/ethnicity. Related protocols: CTN-0047

Abstract:

High levels of missing outcome data for biologically confirmed substance use (BCSU) threaten the validity of substance use disorder (SUD) clinical trials. Underlying attributes of clinical trials could explain BCSU missingness and identify targets for improved trial design.

We reviewed 21 clinical trials funded by the NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) and published from 2005 to 2018 that examined pharmacologic and psychosocial interventions for SUD. We used configurational analysis-a Boolean algebra approach that identifies an attribute or combination of attributes predictive of an outcome-to identify trial design features and participant characteristics associated with high levels of BCSU missingness. Associations were identified by configuration complexity, consistency, coverage, and robustness. We limited results using a consistency threshold of 0.75 and summarized model fit using the product of consistency and coverage.

For trial design features, the final solution consisted of two pathways: psychosocial treatment as a trial intervention OR larger trial arm size (complexity=2, consistency=0.79, coverage=0.93, robustness score=0.71). For participant characteristics, the final solution consisted of two pathways: interventions targeting individuals with poly- or nonspecific substance use OR younger age (complexity=2, consistency=0.75, coverage=0.86, robustness score=1.00).

Conclusions: Psychosocial treatments, larger trial arm size, interventions targeting individuals with poly- or nonspecific substance use, and younger age among trial participants were predictive of missing BCSU data in SUD clinical trials. Interventions to mitigate missing data that focus on these attributes may reduce threats to validity and improve utility of SUD clinical trials.

Related protocols: CTN-0002, CTN-0003, CTN-0004, CTN-0006, CTN-0007, CTN-0009. CTN-0013, CTN-0014, CTN-0015, CTN-0017, CTN-0021, CTN-0029, CTN-0030, CTN-0031, CTN-0037, CTN-0044, CTN-0046, CTN-0048, CTN-0051, CTN-0053

Abstract:

Clinical trial recruitment and retention of individuals who use substances are challenging in any setting and can be particularly difficult in emergency department (ED) settings. This article discusses strategies for optimizing recruitment and retention in substance use research conducted in EDs.

Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED, CTN-0047) was a National Drug Abuse Treatment Clinical Trials Network (CTN) protocol designed to assess the impact of a brief intervention with individuals screening positive for moderate to severe problems related to use of non-alcohol, non-nicotine drugs. We implemented a multisite, randomized clinical trial at six academic EDs in the United States and leveraged a variety of methods to successfully recruit and retain study participants throughout the 12-month study course. Recruitment and retention success is attributed to appropriate site selection, leveraging technology, and gathering adequate contact information from participants at their initial study visit.

The SMART-ED recruited 1,285 adult ED patients and attained follow-up rates of 88%, 86%, and 81% at the 3-, 6-, and 12-month follow-up periods, respectively. Participant retention protocols and practices were key tools in this longitudinal study that required continuous monitoring, innovation, and adaptation to ensure strategies remained culturally sensitive and context appropriate through the duration of the study.

Conclusions: Tailored strategies that consider the demographic characteristics and region of recruitment and retention are necessary for ED-based longitudinal studies involving patients with substance use disorders.

Related protocols: CTN-0047

Abstract:

Brief Interventions (BIs) for problematic drug use in general medical settings, including in Emergency Departments (EDs), have shown disappointing results compared to those that target problematic alcohol use. Telephone booster calls may augment the impact of a BI delivered in the ED. The current study uses data from the National Drug Abuse Treatment Clinical Trials Network (CTN) Protocol CTN-0047, “Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED),” a multisite randomized clinical trial conducted in six EDs in the U.S. Researchers examine dose effects of telephone boosters (0, 1, or 2 calls completed) with non-treatment-seeking patients who were randomized to the BI-Booster condition and who endorsed problematic drug use during their ED visit (N=427). Primary outcomes were assessed at 3-, 6-, and 12-month follow-ups, which included past month use of the primary drug of choice, use of any drug, and heavy drinking. There were no significant differences among those completing 0, 1, or 2 booster calls on any of the three main outcomes at 3-, 6-, and 12-months post-BI in the ED. Patients who were older were significantly more likely to complete booster calls.

Conclusions: The parent SMART-ED study had found no benefit of BI or BI plus telephone calls over and above minimal screening. This secondary analysis of data from that study further indicates that the number of booster calls that participants completed in the BI-B condition, ranging from 0 to 2, was not associated with different drug use or heavy alcohol use outcomes. These findings raise questions about the clinical utility of booster phone calls following screening and BIs targeting heterogeneous drug use in the ED.

Related protocols: CTN-0047

Abstract:

This secondary analysis of data from NIDA Clinical Trials Network protocol CTN-0047 (Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED)) aimed to investigate the utility of hair analysis in drug use disorder trials with infrequent visits, and its concordance with Timeline Follow Back (TLFB). This study compared the self-reported drug use on the TLFB instrument with the biological measure of drug use from hair analysis for four major drug classes (cannabis, cocaine, prescribed opioids, and street opioids). Both hair analysis and TLFB were conducted at 3, 6, and 12 month follow-up visit and each covered a 90-day recall period prior to the visit.

The concordance between the hair sample results and the TLFB was high for cannabis and street opioids, but was low to moderate for cocaine and prescribed opioids. Under-reporting of drug use given the positive hair sample was always significantly lower for the drug the study participant noted as their primary drug of choice compared with other drugs the participant reported taking, irrespective of whether the drug of choice was cannabis, cocaine, street opioids, and prescribed opioids. Over-reporting of drug use given the negative hair sample was always significantly higher for the drug of choice, expect for cocaine.

Conclusions: This study extends the literature on hair analysis supporting its use as a secondary outcome measure in clinical trials, particularly when assessing long-term abstinence, given its extended window of detection compared to typical follow-up sessions, for which urine drug testing may be more appropriate. Reliability varied considerably by drug category and by site, indicating that the target drug and participant characteristics should be considered when weighing the pros and cons of employing hair testing as an objective cost measure.

Related protocols: CTN-0047

Abstract:

Learning motivational interviewing (MI) is an ongoing process, involving much more than attendance at a single workshop. Once proficiency is achieved, therapists benefit from ongoing coaching with individual feedback based on observed practice to ensure continued fidelity. The aim of this study was to assess outcomes of the unique training and supervision model employed in a recent trial of MI. The intervention tested in the six-site National Drug Abuse Treatment Clinical Trials Network protocol CTN-0047 trial was a 30-minute MI-based brief intervention delivered in the emergency department followed by two telephone booster calls delivered from a centralized call center. Thirty-one counselors and 3 booster counselors were trained in the intervention using a 2-stage process: local training in the MI process of engagement followed one month later by a 2-day training in MI. We employed a two-level model in which the formal coding was separated from the clinical supervision. One audio file per interventionist per week was coded using the MITI 3.1.1 coding system. This written feedback was available to clinical supervisors, who reviewed coding results during telephone supervision sessions.

Eleven percent of sessions were coded on an ongoing basis during the trial, with a total of 380 initial sessions (90%) and 83 booster sessions (20%) coded upon completion of the trial. Mean global scores for initial sessions ranged from 4.25 to 4.67, and for the booster sessions from 4.64 to 4.86, well above the proficiency benchmark of 4.0. Inter-rater reliability assessed on a random sample of 124 tapes was excellent, with ICCs averaging 0.81 for global scores and 0.93 for behavior counts. On a therapist level, MITI scores tended to improve over time, demonstrating the strategies employed helped with adherence and continued learning in MI.

Conclusions: A comprehensive strategy for successfully learning and maintaining skills in MI emerged from the CTN-0047 study, which employed a rigorous and novel plan for ensuring therapists adhered to the style of MI.

Related protocols: CTN-0047

Abstract:

This secondary analysis of data from the National Drug Abuse Treatment Clinical Trials Network’s “Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED)” study (CTN-0047) aimed to improve understanding of the patterns of daily self-reported drug use among participants. In the original trial, daily self-reported drug use data were collected via Time-line Follow Back (TLFB) at baseline to assess the 30-day baseline measure of substance use and for 90-day periods during follow-up prior to the 3, 6 and 12 month follow-up visits. Patterns of daily drug use (self-reported drug use percent on a given day) using line plots over the one-year period were investigated to describe short-term temporal variations over 7 day periods to describe impact of day of the week, as well as temporal variations over longer periods of time.
Results found a reduction in self-reported drug use days over the one-year period. For cocaine, baseline self-reported drug use reduced from 12% for the 30 days prior to baseline to 8% for the 90 days preceding the Month 3 visit, 6.4% for the 90 days preceding the Month 6 visit, and 5.4% for the 90 days preceding the Month 12 visit. Although there was higher self-reported use for cannabis and any drug, similar trends were observed over the one-year period. For the weekly temporal patterns, self-reported drug use percent was always higher on Friday and Saturday (Any drug = 46%-47%, Cannabis = 30%-31% and Cocaine = 9.1%-9.5%) compared with other days of the week (Any drug = 40%, Cannabis = 25%-26% and Cocaine = 6%-6.4%). Moreover, the weekly self-reported drug use pattern was similar throughout the assessment period for a given visit.

Conclusions: This study helps understand the pattern of the self-reported drug use in patients presenting in an emergency department. Overall, the percent of drug use days continues to decrease over time, suggesting attending a follow-up visit as part of the research study may have impacted self-reported drug use. Higher drug use on Fridays and Saturdays shows weekend effect on the self-reported drug use.

Related protocols: CTN-0047

Abstract:

This secondary analysis of data from the National Drug Abuse Treatment Clinical Trials Network’s “Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED)” study (CTN-0047) aimed to examine predictors of agreement between hair analyses and self-report of drug use. Self-reported drug use during follow-up over a 90-day recall period on the Timeline Follow Back Instrument was compared to drug use from hair analysis for Cannabis, Cocaine, Prescribed Opioids [PO] and Street Opioids[SO]. Measures of agreement/disagreement, including under-reporting (self report negative when hair indicates drug use) and over-reporting (self-report positive when hair does not indicate drug use) were calculated. The following variables were examined as predictors of disagreement: source of hair (head vs. body), drug of choice, site, AUDIT-C score, DAST-10 score, visit, treatment arm, sex, race, ethnicity and age. Of the 1,285 randomized participants, 1120 (87%), 875 (68%), 893 (69%) and 832 (65%) provided hair samples at baseline, 3-, 6-, 12-month visits, respectively.

The agreement between the hair sample results and TLFB was high for cannabis (cohen’s = 0.49-0.54) and SO ( = 0.73-0.81), but lower for cocaine ( = 0.31-0.35) and PO ( = 0.18-0.30). Drug of choice, irrespective of being cannabis, cocaine, SO or PO, had statistically significantly lower under-reporting of drug use compared with other self-reported drug use (all p-values < .01). Of note, females (p=.0085; F vs M; OR = 1.33) and older age (p=.0076; 45-<55 vs 18-<25; OR = 2.02) were associated with under-reporting of cannabis use. Few predictors of over-reporting were identified.

Conclusions: Hair collection can be an important biological measure to assess drug use, and can be used to assist in corroborating self-report. From these analyses, there are a number of factors that impact agreement between drug use as measured by hair and drug use through self-report.

Related protocols: CTN-0047

Abstract:

This is the primary outcomes article for CTN-0047.

Medical treatment settings such as emergency departments (EDs) present important opportunities to address problematic substance use. Currently, EDs do not typically intervene beyond acute medical stabilization. This study aimed to contrast the effects of a brief intervention with telephone boosters (BI-B) with those of screening, assessment, and referral to treatment (SAR) and minimal screening only (MSO) among drug-using ED patients. Between October 2010 and February 2012, 1285 adult ED patients from 6 US academic hospitals, who scored 3 or greater on the 10-item Drug Abuse Screening Test (indicating moderate to severe problems related to drug use) and who were currently using drugs, were randomized to MSO (n=431), SAR (n=427), or BI-B (n=427). Follow-up assessment were conducted at 3, 6, and 12 months by blinded interviewers. Following screening, MSO participants received only an informational pamphlet; SAR participants received assessment plus referral to addiction treatment if indicated, and BI-B participants received assessment and referral as in SAR, plus a manual-guided counseling session based on motivational interviewing principles and up to 2 “booster” sessions by telephone during the month following the ED visit. Outcomes evaluated at follow-up visits included self-reported days using the patient-defined primary problem drug, days using any drug, days of heavy drinking, and drug use based on analysis of hair samples. The primary outcome was self-reported days of use of the patient-defined primary problem drug during the 30-day period preceding the 3-month follow-up.

Follow-up rates were 89%, 86%, and 81% at 3, 6, and 12 months, respectively. There were no significant differences between groups in self-reported days using the primary drug, days using any drug, or heavy drinking days at 3, 6, or 12 months. At the 3-month follow-up, participants in the SAR group had a higher rate of hair samples positive for their primary drug of abuse (265 of 280, 95%) than did participants in the MSO group (253 or 287, 88%) or the BI-B group (244 of 275, 89%). Hair analysis differences between groups at other time points were not significant.

Conclusions: The findings of this study suggest that even a relatively robust brief intervention such as the one implemented in this trial is unlikely to be useful as a general strategy for the population recruited for this trial (ED patients with relatively severe drug problems and other life challenges). Further research will be needed to explore more intensive interventions targeting the most severely affected patients with substance use disorder visiting the ED and to ascertain whether screening and brief interventions play a useful roll in the treatment of ED patients less severely affected by drug use disorders.

Related protocols: CTN-0047

Abstract:

Post-visit “booster” sessions have been recommended to augment the impact of brief interventions delivered in the emergency department (ED). This paper, which focuses on implementation issues, presents descriptive information and interventionists’ qualitative perspectives on providing brief motivational interviewing-based interventions over the phone, challenges, “lessons learned,” and recommendations for others attempting to implement adjunctive booster calls.

In the National Drug Abuse Treatment Clinical Trials Network study, “Screening Motivational Assessment and Referral to Treatment in Emergency Departments” (SMART-ED), attempts were made to complete two 20-minute telephone “booster” calls within a week following a patient’s ED discharge with 425 patients who screened positive for and had recent problematic substance use other than alcohol or nicotine. Over half (56.2%) of participants completed the initial call; 66.9% of those who received the initial call also completed the second call. Median number of attempts to successfully contact participants for the first and second calls was 4 and 3, respectively. Each completed call lasted an average of about 22 minutes. Common challenges/barriers identified by booster callers included unstable housing, limited phone access, unavailability due to additional treatment, lack of compensation for booster calls, and booster calls coming from an area code different than the participants’ locale and from someone other than ED staff, which some participants found confusing and suspicious.

Conclusions: The results of this inquiry demonstrate that a team of booster interventionists and supporting staff can overcome the challenges in implementing a remotely located, centralized booster call center. Specific recommendations are presented with respect to implementing a successful system. Future use of booster calls might be informed by research on contingency management (e.g., incentivizing call completions, which could help address the barrier related to lack of remuneration), smoking cessation quitlines, and phone-based continuing care for substance abuse patients. Future research needs to evaluate the incremental benefit of adjunctive booster calls on outcomes over and above that of brief motivational interventions delivered in the emergency department setting.

Related protocols: CTN-0047

Abstract:

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:

Introduction

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

Abstract:

Drug-related emergency department (ED) visits have steadily increased, with substance users relying heavily on the ED for medical care. This secondary analysis of data from the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0047 (Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED)) aimed to identify clinical correlates of problematic drug use that would facilitate identification of ED patients in need of substance use treatment.

Using previously validated tests, 15,224 adult ED patients across 6 academic institutions were prescreened for drug use as part of a large randomized prospective trial. Data for 3,240 participants who reported drug use in the past 30 days were included. Self-reported variables related to demographics, substance use, and ED visit were examined to determine their correlative value for problematic drug use. Of the 3,240 patients, 2,084 (64.3%) met criteria for problematic drug use (Drug Abuse Screening Test score >= 3). Age greater than or equal to 30 years, tobacco smoking, daily or binge alcohol drinking, daily drug use, primary noncannabis drug use, resource-intense ED triage level, and perceived drug-relatedness of ED visit were highly correlated with problematic drug use. Among primary cannabis users, correlates of problematic drug use were age younger than 30 years, tobacco smoking, binge drinking, daily drug use, and perceived relatedness of the ED visit to drug use. A brief clinical decision tool, developed as part of this study, demonstrated an 88% positive predictive value and would allow clinicians to more rapidly determine whether detailed assessment for a drug problem is indicated in a patient who has used any drug in the past 30 days.

Conclusions: The higher emergency department utilization and hospital admission rates among ED patients with unmet substance abuse treatment needs argue for greater attention to the development of multidisciplinary, cost-effective ways to support ED-based substance use screening, intervention, and referral to treatment. The correlation between problematic drug use and resource-intense ED triage levels in this analysis offers further evidence that ED patients with unmet substance abuse treatment needs incur higher health care costs than their counterparts, and highlights the potential opportunity for decreasing overall health care cost by identifying those patients who are at highest risk of problematic drug use and referring them to treatment. The screening and clinical decision rule proposed here provides a rapid and simple method of identifying patients on whom more comprehensive ED-based SBIRT should be focused as part of emergency care practice. This research and future cost-effectiveness research could inform policy and resource allocation for the advancement of ED-based drug abuse mitigating-activities.

Related protocols: CTN-0047

Abstract:

The prevalence of alcohol, tobacco, and other drug (ATOD) use among emergency department (ED) patients is high and many of these patients have unrecognized and unmet substance use treatment needs. Identification of patients in the ED with problem substance use is not routine at this time. In this study, investigators examined screening data, including standardized measures of ATOD use (HSI, AUDIT-C, DAST-10), from 14,866 ED patients in six hospitals across the United States participating in the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0047 (“Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED)”). Younger age, male gender, higher triage acuity, and other substance use severity were expected to be associated both with use versus abstinence and with severity of each substance use type. Negative binomial hurdle models were used to examine the association between covariates and these two elements.

Rates of use and problem use in the study sample were similar to or higher than in other ED samples. Younger patients and males were more likely to use ATOD, but the association of age and gender with severity varied across substances. Triage level was a poor predictor of substance use severity. Alcohol, tobacco, and drug use were significantly associated with using other substances and severity of other substance use.

Conclusions: Better understanding of the demographic correlates of ATOD use and severity and the patterns of comorbidity among classes of substance can inform the design of optimal screening and brief intervention procedures addressing ATOD use among ED patients. Tobacco may be an especially useful predictor.

Related protocols: CTN-0047

Abstract:

Interventionists (N=30, 11 male, 19 female) involved in the six-site National Drug Abuse Treatment Clinical Trials Network Screening, Motivational Assessment, Referral and Treatment in Emergency Departments (SMART-ED) protocol (CTN-0047) delivered 30-minute motivational enhancement therapy-based brief interventions (BI) to patients presenting with problematic substance use during an ED visit. Following the treatment phase of this study, we gathered information on themes in session content that interventionists identified as recurrent. This poster presents descriptive information regarding BI session content. Interventionists completed a survey that included questions on demographics, affiliated ED, and estimates of the number of interventions delivered. Respondents were asked to describe themes that stood out to them during their sessions as well as to list themes they noticed across different domains (e.g., gender differences). A qualitative approach was used to code and analyze responses. Twenty-one interventionists (70%) completed the survey. Respondents reported completing an average of 16-20 sessions during the trial. Five interventionists responded that patients seemed highly ambivalent about making a change in their substance use. Eight reported that most patients did not see their ED visit as related to their substance use. Fifteen interventionists found that patients viewed opioid and IV drug use as more severe/in need of change than marijuana use, although severity and consequences scores were roughly equivalent for these drugs classes. Four interventionists noted that females tended to be more aware of and affected by consequences related to their substance use, despite having lower rates of consumption. Finally, six interventionists reported that patients who had previous exposure to treatment were more open to discussions about their substance use.

Conclusions: Interventionists identified recurrent themes noticed during the delivery of the brief intervention. Knowledge of these themes may be useful to those providing substance use interventions in an ED setting.

Related protocols: CTN-0047

Abstract:

Addiction is a chronic brain disease with consequences that remain problematic years after discontinuation of use. Despite this, treatment models focus on acute interventions and are carved out from the main health care system. The Patient Protection and Affordable Care Act (2010) brings the opportunity to change the way substance use disorder (SUD) is treated in the United States. The treatment of SUD must adapt to a chronic care model offered in an integrated care system that screens for at-risk patients and includes services needed to prevent relapses. The partnering of the health care system with substance abuse treatment programs could dramatically expand the benefits of prevention and treatment of SUD. Screening, Brief Intervention, and Referral to Treatment (SBIRT), the subject of National Drug Abuse Treatment Clinical Trials Network protocols CTN-0047 (SMART-ED) and CTN-0057-Ot (SBIRT-PC), is cited as an effective strategy in identifying and intervening drug problems in emergency departments and primary care and improving health outcomes. Expanding roles of health information technology and nonphysician workforces, such as social workers, are essential to the success of a chronic care model.

This article by the Director of the Center for the Clinical Trials Network (CCTN, Dr. Tai) and the Director of the National Institute on Drug Abuse (NIDA, Dr. Volkow) is part of a special issue of the journal Social Work in Public Health about “The Role of Social Work in the Prevention and Treatment of Substance Use Disorders” that includes a number of articles about the National Drug Abuse Treatment Clinical Trials Network (CTN). See [*URL*] for more information about the issue.

Related protocols: CTN-0047, CTN-0057-Ot