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CompletedNCT01124591BIDMEDUpdated Jun 10, 2015

Brief Intervention for Drug Misuse in the Emergency Department

A Phase 2 interventional study of Brief motivational intervention in Substance Abuse Detection, HIV and Hepatitis B, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2015-06-10.

Sponsored by Rhode Island Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
1,030
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

Although screening, brief intervention, and referral to treatment (SBIRT) approaches are effective in reducing alcohol misuse and its associated risk-taking behaviors and negative consequences, there is little research demonstrating the effectiveness of SBIRT for illicit and/or prescription drug misuse. Misusers of illicit and/or prescription drugs frequently seek medical care in emergency departments (EDs), particularly for reasons related to their misuse. As a result, the ED is well suited as a site to conduct an analysis of the effectiveness of SBIRT for this population.

The Brief Intervention for Drug Misuse for the Emergency Department (BIDMED) study is a randomized, controlled, trial that will include adult ED patients at a large, academic, trauma center (Rhode Island Hospital) and a community hospital (The Miriam Hospital) who have a subcritical illness or injury and whose screening indicates illicit and/or prescription drug misuse. BIDMED participants will be randomized to receive screening only (SO) or brief intervention (BI) with appropriate referral to treatment. Participants will complete a battery of blinded baseline assessments using standardized instruments as well as adapted instruments specific to the aims of this study. All participants will undergo blinded follow-up assessments at three, six, and twelve months post-randomization. The primary hypotheses addressed in the BIDMED study are that, compared to participants in the SO arm, participants in the BI arm will show a significantly greater reduction in: (1) drug misuse within the prior 30 days at three months post-randomization, (2) behaviors associated with drug misuse at six months post-randomization; and (3) negative physical health, psychosocial health, and socioeconomic consequences at twelve months post-randomization. As a secondary aim, the impact of BI compared to SO will be assessed on participants contacting, enrolling in, and completing a drug treatment program. In addition, the impact of BI compared to SO on increasing uptake of HIV and hepatitis B/C screening will be measured. A mechanisms of change model that addresses the expected mediators and moderators of change to explain the effects of SBIRT in this setting will also be developed and tested. Further, the epidemiology of illicit and/or prescription drug misuse will be assessed in a random sample of ED patients.

02

Conditions studied

  • Substance Abuse Detection
  • HIV
  • Hepatitis B
  • Hepatitis C
  • Brief Intervention
  • HIV Infections
03

In context

Hepatitis A

2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 1,030 is above the median of 100 across 1,887 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Rhode Island Hospital is the lead sponsor of 187 studies on the registry; 37 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Self-report of illicit and/or prescription drug misuse in the past three-months. Presenting at the emergency department for medical care.

Exclusion criteria

Exclusion Criteria:

Not age appropriate, in custody, medically unstable, actively psychotic, suicidal

-

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
1,030 participants (actual)

Study arms

  • Experimental
    Treatment

    Assessment and brief intervention

    Behavioral: Brief motivational intervention

Interventions

  • BehavioralBrief motivational intervention

    two session delivered two weeks apart

06

What researchers measure

Primary outcomes

  1. Reduction in past 30 day drug misuse

    Time frame: 12 months post-randomization

  2. Reduction in behaviors associated with drug misuse

    Time frame: 12 months post-randomization

  3. Reduction negative physical health, psychosocial health, and socioeconomic consequences

    Time frame: 12 months post-randomization

Secondary outcomes

  1. Uptake of HIV and hepatitis B/C screening

    Time frame: 3 months post randomization

07

Study locations

1 site
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
08

References and documents

Publications

  • Merchant RC, Zhang Z, Zhang Z, Liu T, Baird JR. Lack of efficacy in a randomised trial of a brief intervention to reduce drug use and increase drug treatment services utilisation among adult emergency department patients over a 12-month period. Emerg Med J. 2018 May;35(5):282-288. doi: 10.1136/emermed-2016-206540. Epub 2018 Feb 2. PubMed 29437758 ↗
  • Guan W, Liu T, Baird JR, Merchant RC. Evaluation of a brief intervention to reduce the negative consequences of drug misuse among adult emergency department patients. Drug Alcohol Depend. 2015 Dec 1;157:44-53. doi: 10.1016/j.drugalcdep.2015.10.007. Epub 2015 Oct 13. PubMed 26482090 ↗
  • Merchant RC, Baird JR, Liu T. Short-term Efficacy of a Brief Intervention to Reduce Drug Misuse and Increase Drug Treatment Utilization Among Adult Emergency Department Patients. Acad Emerg Med. 2015 Oct;22(10):1172-80. doi: 10.1111/acem.12767. Epub 2015 Sep 16. PubMed 26375468 ↗
  • Merchant RC, Baird JR, Liu T, Taylor LE. HCV among The Miriam Hospital and Rhode Island Hospital Adult ED Patients. R I Med J (2013). 2014 Jul 1;97(7):35-9. PubMed 24983020 ↗
  • Bernardino VL, Baird JR, Liu T, Merchant RC. Comparison of substance-use prevalence among Rhode Island and The Miriam Hospital Emergency Department patients to state and national general population prevalence estimates. R I Med J (2013). 2014 Apr 1;98(4):30-4. PubMed 25830171 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01124591
Lead sponsor
Rhode Island Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Roland C. Merchant, MD. MPH, ScD (Attending Physician, Rhode Island Hospital) — Principal investigator
First posted
May 17, 2010
Start date
Jun 2010
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jun 10, 2015

Study contacts

Roland C Merchant, MD; ScD
principal investigator · Rhode Island Hospital
Ted Nirenberg, PhD
principal investigator · Rhode Island Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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