NCT00183105

Brief Summary

The objective of this project was to test whether screening and brief intervention for unhealthy alcohol use leads to improved alcohol-related outcomes (such as alcohol consumption and linkage to alcohol assistance) and is cost-effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 6, 2010

Status Verified

December 1, 2007

First QC Date

September 9, 2005

Last Update Submit

May 5, 2010

Conditions

Alcohol DependenceAlcohol Consumption

Keywords

AlcoholAlcohol abuseAlcohol dependenceUtilizationAlcohol consumptionUnhealthy alcohol useHospitalizationScreeningBrief InterventionMotivational InterviewingRandomized trialEffectivenessUnhealthy alcohol use (Risky alcohol consumption amounts, problem alcohol use, hazardous alcohol use, alcohol abuse and alcohol dependence)

Outcome Measures

Primary Outcomes (2)

  • Linkage to alcohol assistance

  • Change in drinks per day

Secondary Outcomes (9)

  • Change in the number of times a subject exceeded per occasion limits

  • Abstinence (dichotomous)

  • Change in drinks per day

  • Drinking risky amounts (dichotomous)

  • Binge drinking (dichotomous)

  • +4 more secondary outcomes

Interventions

Brief Intervention (adaptation of motivational interviewing)BEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Fluent in English or Spanish
  • Consume risky amounts of alcohol
  • Provide 2 contacts to assist with follow-up
  • Have no plans to move from the local area within a year of screening
  • Score \>21 on Mini-Mental State Examination (no serious cognitive impairment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

  • Kraemer KL, Roberts MS, Horton NJ, Palfai T, Samet JH, Freedner N, Tibbetts N, Saitz R. Health utility ratings for a spectrum of alcohol-related health states. Med Care. 2005 Jun;43(6):541-50. doi: 10.1097/01.mlr.0000163644.97251.14.

    PMID: 15908848RESULT

  • Saitz R, Palfai TP, Cheng DM, Horton NJ, Freedner N, Dukes K, Kraemer KL, Roberts MS, Guerriero RT, Samet JH. Brief intervention for medical inpatients with unhealthy alcohol use: a randomized, controlled trial. Ann Intern Med. 2007 Feb 6;146(3):167-76. doi: 10.7326/0003-4819-146-3-200702060-00005.

    PMID: 17283347DERIVED

MeSH Terms

Conditions

AlcoholismAlcohol DrinkingPatient Acceptance of Health Care

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehaviorTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Richard Saitz, M.D., M.P.H.

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

February 1, 2001

Study Completion

April 1, 2006

Last Updated

May 6, 2010

Record last verified: 2007-12

Locations

US(1)