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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00547963
Other study ID # NIAAA-BAI-013709
Secondary ID NIH Grant number
Status Active, not recruiting
Phase Phase 2/Phase 3
First received October 19, 2007
Last updated October 7, 2008
Start date December 2003
Est. completion date December 2008

Study information

Verified date October 2008
Source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 554
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
brief counseling
baseline assessment + two 40 minute sessions of brief counseling

Locations

Country Name City State
United States Injury Prevention Center, Rhode Island Hospital, Brown University Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Substance use; injuries, alcohol and marijuana negative consequences 3 and 12 months No
Secondary Mediators and moderators of treatment efficacy 3 and 12 months No
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