Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Brief Intervention for Drug Misuse in the Emergency Department (BIDMED)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roland C. Merchant, MD. MPH, ScD, Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01124591
First received: May 10, 2010
Last updated: January 20, 2014
Last verified: January 2014

May 10, 2010
January 20, 2014
June 2010
December 2014   (final data collection date for primary outcome measure)
  • Reduction in past 30 day drug misuse [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]
  • Reduction in behaviors associated with drug misuse [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]
  • Reduction negative physical health, psychosocial health, and socioeconomic consequences [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]
  • Reduction in past 30 drug misuse [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]
  • Reduction in behaviors associated with drug misuse [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]
  • Reduction negative physical health, psychosocial health, and socioeconomic consequences [ Time Frame: 12 months post-randomization ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01124591 on ClinicalTrials.gov Archive Site
Uptake of HIV and hepatitis B/C screening [ Time Frame: 3 months post randomization ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Brief Intervention for Drug Misuse in the Emergency Department
Clinical Trial to Determine the Effect of a Brief Behavioral Intervention in Reducing Drug Misuse Among an Emergency Department Population

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Substance Abuse Detection
  • HIV
  • Hepatitis B
  • Hepatitis C
  • Brief Intervention
  • HIV Infections
Behavioral: Brief motivational intervention
two session delivered two weeks apart
Experimental: Treatment
Assessment and brief intervention
Intervention: Behavioral: Brief motivational intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1100
December 2014
December 2014   (final data collection date for primary outcome measure)

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:

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

-

Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01124591
0113-09
Yes
Roland C. Merchant, MD. MPH, ScD, Rhode Island Hospital
Rhode Island Hospital
National Institute on Drug Abuse (NIDA)
Principal Investigator: Roland C Merchant, MD; ScD Rhode Island Hospital
Principal Investigator: Ted Nirenberg, PhD Rhode Island Hospital
Rhode Island Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP