Posts Tagged ‘CTN-0047’

Outcomes from CTN-0047: No Significant Differences Between Treatment Groups

September 9, 2014

edMedical 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, National Drug Abuse Institute Clinical Trials Network protocol CTN-0047 (“Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED)“) 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.  The Pacific Northwest Node was the co-lead node on this project. 

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, each group received:

  • MSO participants: only an informational pamphlet;
  • SAR participants: assessment plus referral to addiction treatment if indicated;
  • BI-B participants:  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.

Results found 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.

Citation: Bogenschutz MP, Donovan DM, Mandler RN, et al. Brief Intervention for Patients with Problematic Drug Use Presenting in Emergency Departments: A Randomized Clinical Trial. JAMA Internal Medicine 2014 (in press).

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Updates from CTN-0047 Presented at 2012 INEBRIA Conference

November 1, 2012

The 9th Conference of the International Network on Brief Interventions for Alcohol & Other Drugs (INEBRIA), held Barcelona, Spain, September 2012, featured a session about the National Drug Abuse Treatment Clinical Trials Network protocol “Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED): Evaluation of Screening, Brief Intervention, Referral to Treatment (SBIRT) and Booster Session for Drug Use Patients Presenting for Treatment” (SMART-ED).

The Pacific Northwest Node is a participant in this protocol, and Node PI Dennis Donovan gave one of the presentations.

Michael Bogenschutz, MD, of the Southwest Node chaired the session, which included presentations about recruitment, enrollment, assessment, training, and challenges experienced by protocol researchers and clinicians:

Recruitment & Retention: SMART-ED, NIDA CTN-0047 — Cameron Crandall, Raul Mandler, Michael Bogenschutz, et al.

Screening, Enrollment, and Assessment in the SMART-ED Study — Robert Lindblad, Ro Shauna Rothwell.

Intervention Training, Supervision and Fidelity Monitoring in NIDA CTN-0047: SMART-ED — Alyssa Forcehimes, Karin Wilson, Theresa Moyers, et al.

Qualitative Reports of Interventionists in the SMART-ED Study: Challenges and Themes — Dennis Donovan, Melissa Phares, Ernie McGarry, et al.

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Potential Role of Assessment Reactivity in SMART-ED Protocol (CTN-0047)

September 4, 2012

Screening, brief intervention, and referral to treatment (SBIRT) approaches to reducing hazardous alcohol and illicit drug use have been assessed in a variety of health care settings, including primary care, trauma centers, and emergency departments. A major methodological concern in these trials, however, is “assessment reactivity,” the hypothesized impact of intensive research assessments to reduce alcohol and drug use and thus mask the purported efficacy of the interventions under scrutiny.

Assessment reactivity is a potential source of bias that may reduce and/or lead to an underestimation of the purported effectiveness of brief interventions. From a methodological perspective, it needs to be accounted for in research design. This article in Addiction Science & Clinical Practice, by Pacific Northwest Node PI Dennis Donovan and colleagues, describes the design of the National Drug Abuse Treatment Clinical Trials Network (CTN) protocol, “Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments” (SMART-ED, CTN-0047), which addresses the potential bias of assessment reactivity using a 3-arm design.

The SMART-ED design offers an approach to minimize assessment reactivity as a potential source of bias. Elucidating the role of assessment reactivity may offer insights into the mechanisms underlying SBIRT as well as suggest clinical options incorporating assessment reactivity as a treatment adjunct.

Citation: Donovan DM, Bogenschutz MP, Perl HI, et al. Study Design to Examine the Potential Role of Assessment Reactivity in Screening, Motivational Assessment, Referral and Treatment in Emergency Departments (SMART-ED) Protocol. Addiction Science & Clinical Practice 2012;7:16.

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