NCT00547963

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
554

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 8, 2008

Status Verified

October 1, 2008

Enrollment Period

5 years

First QC Date

October 19, 2007

Last Update Submit

October 7, 2008

Conditions

Alcohol DrinkingMarijuana Smoking

Keywords

Alcohol DrinkingMarijuana SmokingSubstance UseEmergency Department (ED)

Outcome Measures

Primary Outcomes (1)

  • Substance use; injuries, alcohol and marijuana negative consequences

    3 and 12 months

Secondary Outcomes (1)

  • Mediators and moderators of treatment efficacy

    3 and 12 months

Study Arms (1)

1

EXPERIMENTAL

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

Behavioral: brief counseling

Interventions

brief counselingBEHAVIORAL

baseline assessment + two 40 minute sessions of brief counseling

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Injury Prevention Center, Rhode Island Hospital, Brown University

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Alcohol DrinkingMarijuana SmokingSubstance-Related DisordersEmergencies

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorMarijuana UseSmoking, Non-Tobacco ProductsSmokingChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Janette Baird, PhD

    Injury Prevention Center, Rhode Island Hospital, Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 19, 2007

First Posted

October 23, 2007

Study Start

December 1, 2003

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 8, 2008

Record last verified: 2008-10

Locations

US(1)