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

Primary Purpose

Alcohol Drinking, Marijuana Smoking

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
brief counseling
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking focused on measuring Alcohol Drinking, Marijuana Smoking, Substance Use, Emergency Department (ED)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Injury Prevention Center, Rhode Island Hospital, Brown University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

Substance use; injuries, alcohol and marijuana negative consequences

Secondary Outcome Measures

Mediators and moderators of treatment efficacy

Full Information

First Posted
October 19, 2007
Last Updated
October 7, 2008
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00547963
Brief Title
Brief Counseling to Reduce Injuries Among Emergency Department Patients Who Report Alcohol and Substance Use
Official Title
Reducing Injury, ETOH and THC Use Among ED Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2003 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Marijuana Smoking
Keywords
Alcohol Drinking, Marijuana Smoking, Substance Use, Emergency Department (ED)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
554 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
two brief counseling sessions delivered to ED patients who report conjoint alcohol and marijuana use
Intervention Type
Behavioral
Intervention Name(s)
brief counseling
Intervention Description
baseline assessment + two 40 minute sessions of brief counseling
Primary Outcome Measure Information:
Title
Substance use; injuries, alcohol and marijuana negative consequences
Time Frame
3 and 12 months
Secondary Outcome Measure Information:
Title
Mediators and moderators of treatment efficacy
Time Frame
3 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janette Baird, PhD
Organizational Affiliation
Injury Prevention Center, Rhode Island Hospital, Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Injury Prevention Center, Rhode Island Hospital, Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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

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