View Clinical Trial (Medical Research Study)
Clinical Trial to Determine the Effect of a Brief Behavioral Intervention in Reducing Drug Misuse Among an Emergency Department Population
| City: |
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Providence |
| State: |
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Rhode Island |
| Zip Code: |
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02903 |
| Conditions: |
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Substance Abuse Detection - Acquired Immunodeficiency Syndrome - Hepatitis B - Hepatitis C - Brief Intervention - HIV Infections |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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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| NCT ID: |
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NCT01124591 |
| Primary Contact: |
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Principal Investigator
Roland C Merchant, MD; ScD
Rhode Island Hospital
Roland C Merchant, MD, ScD
Phone: 401-444-5107
Email: rmerchant@lifespan.org
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| Backup Contact: |
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Email: jbaird@lifespan.org
Janette Baird, PhD
Phone: 401-444-2976
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| Location Contact: |
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Providence, Rhode Island 02903
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 17, 2013 |
| Modifications to this listing: |
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