- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00547963
Brief Counseling to Reduce Injuries Among Emergency Department Patients Who Report Alcohol and Substance Use
Reducing Injury, ETOH and THC Use Among ED Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Alcohol and substance use remain a significant predictor of injuries, health and psychosocial consequences.
ED patients who were not being treated for critical conditions were asked about their use of alcohol and marijuana. Patients who self-reported the use of both substances were asked to participate in the study.
Recruited participants were given a baseline assessment and then randomized a treatment or a control condition. The treatment condition consisted of two 40 minute sessions of brief counseling. The first session took place in the ED the second session occurred within two weeks of being seen in the ED.
Participants completed assessments three and twelve months after being recruited in the ED. The primary dependent variables for this study are 12 month injuries and self-reported levels of negative life consequences associated with alcohol and marijuana use.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Injury Prevention Center, Rhode Island Hospital, Brown University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female outpatients 18 years of age or older.
- Participants will have a current DSM-IV diagnosis of alcohol dependence.
- Participants will have signed a witnessed informed consent.
Exclusion Criteria:
- Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, dementia, or a psychological disorder requiring medication.
- Participants who have had more than seven days of inpatient treatment for substance use disorders in the 30 days previous to randomization.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
two brief counseling sessions delivered to ED patients who report conjoint alcohol and marijuana use
|
baseline assessment + two 40 minute sessions of brief counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Substance use; injuries, alcohol and marijuana negative consequences
Time Frame: 3 and 12 months
|
3 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mediators and moderators of treatment efficacy
Time Frame: 3 and 12 months
|
3 and 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Janette Baird, PhD, Injury Prevention Center, Rhode Island Hospital, Brown University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIAAA-BAI-013709
- NIH Grant number 5R01AA013709
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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