Brief Intervention for Drug Misuse in the Emergency Department (BIDMED)
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ClinicalTrials.gov Identifier: NCT01124591 |
Recruitment Status
:
Completed
First Posted
: May 17, 2010
Last Update Posted
: June 10, 2015
|
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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 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 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment
Assessment and brief intervention
|
Behavioral: Brief motivational intervention
two session delivered two weeks apart
|
- Reduction in past 30 day drug misuse [ Time Frame: 12 months post-randomization ]
- Reduction in behaviors associated with drug misuse [ Time Frame: 12 months post-randomization ]
- Reduction negative physical health, psychosocial health, and socioeconomic consequences [ Time Frame: 12 months post-randomization ]
- Uptake of HIV and hepatitis B/C screening [ Time Frame: 3 months post randomization ]

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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

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 |
Principal Investigator: | Roland C Merchant, MD; ScD | Rhode Island Hospital | |
Principal Investigator: | Ted Nirenberg, PhD | Rhode Island Hospital |
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 Hepatitis A Hepatitis C HIV Infections Emergencies 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 |