We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01124591
Recruitment Status : Completed
First Posted : May 17, 2010
Last Update Posted : June 10, 2015
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Substance Abuse Detection HIV Hepatitis B Hepatitis C Brief Intervention HIV Infections Behavioral: Brief motivational intervention Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1030 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial to Determine the Effect of a Brief Behavioral Intervention in Reducing Drug Misuse Among an Emergency Department Population
Study Start Date : June 2010
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment
Assessment and brief intervention
Behavioral: Brief motivational intervention
two session delivered two weeks apart

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Uptake of HIV and hepatitis B/C screening [ Time Frame: 3 months post randomization ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   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:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124591

United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roland C. Merchant, MD. MPH, ScD, Attending Physician, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01124591     History of Changes
Other Study ID Numbers: 0113-09
First Posted: May 17, 2010    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
HIV Infections
Hepatitis B
Substance-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Disease Attributes
Pathologic Processes
Hepadnaviridae Infections
DNA Virus Infections
Chemically-Induced Disorders
Mental Disorders