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Completed

NCT Number: NCT01124591

Brief Intervention for Drug Misuse in the Emergency Department

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Brief Motivational Intervention

Behavioral

two session delivered two weeks apart

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

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Clinical Trial to Determine the Effect of a Brief Behavioral Intervention in Reducing Drug Misuse Among an Emergency Department Population

Acronym: BIDMED

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 17, 2010
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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