Brief Counseling to Reduce Injuries Among Emergency Department Patients Who Report Alcohol and Substance Use

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2008 by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

ClinicalTrials.gov Identifier:

NCT00547963

First received: October 19, 2007

Last updated: October 7, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

October 19, 2007

Last Updated Date

October 7, 2008

Start Date ^ICMJE

December 2003

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Substance use; injuries, alcohol and marijuana negative consequences [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Substance use; injuries, alcohol and marijuana negative consequences [ Time Frame: 3 and 12 months ]

Change History

Complete list of historical versions of study NCT00547963 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mediators and moderators of treatment efficacy [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Mediators and moderators of treatment efficacy [ Time Frame: 3 and 12 months ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Brief Counseling to Reduce Injuries Among Emergency Department Patients Who Report Alcohol and Substance Use

Official Title ^ICMJE

Reducing Injury, ETOH and THC Use Among ED Patients

Brief Summary

The purpose of this study is to determine the effectiveness of two brief counseling sessions delivered to emergency department (ED) patients who report conjoint alcohol and marijuana use, in reducing injuries and other negative consequences, in comparison to an assessment only group.

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 ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Alcohol Drinking
Marijuana Smoking

Intervention ^ICMJE

Behavioral: brief counseling

baseline assessment + two 40 minute sessions of brief counseling

Study Arm (s)

Experimental: 1

two brief counseling sessions delivered to ED patients who report conjoint alcohol and marijuana use

Intervention: Behavioral: brief counseling

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

554

Estimated Completion Date

December 2008

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00547963

Other Study ID Numbers ^ICMJE

NIAAA-BAI-013709, NIH Grant number 5R01AA013709

Has Data Monitoring Committee

Yes

Responsible Party

Janette Baird, PhD, Injury Prevention Center, Rhode Island Hospital, Brown University

Study Sponsor ^ICMJE

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Janette Baird, PhD

Injury Prevention Center, Rhode Island Hospital, Brown University

Information Provided By

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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