NCT00419315

Brief Summary

A randomized study of Alcohol Care Management for the treatment of alcohol dependence in primary care settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

January 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

November 11, 2014

Completed
Last Updated

May 12, 2015

Status Verified

April 1, 2015

Enrollment Period

3.6 years

First QC Date

January 4, 2007

Results QC Date

October 1, 2014

Last Update Submit

April 24, 2015

Conditions

Alcohol Dependence

Keywords

alcoholismprimary caretreatment

Outcome Measures

Primary Outcomes (1)

  • Treatment Engagement

    This measured the percentage of subjects who attended at least 2 clinical addiction sessions in a given month. The outcome presented is the percentage during the 6th month of the trial.

    6 months

Secondary Outcomes (1)

  • Percent Days of Heavy Alcohol Use

    6 months

Study Arms (2)

Alcohol Care Management

EXPERIMENTAL

Care management for alcohol dependence delivered in primary care

Behavioral: Alcohol Care Management

Usual Care

ACTIVE COMPARATOR

Usual care included a referral to specialty addiction treatment

Behavioral: Usual Care

Interventions

Alcohol Care ManagementBEHAVIORAL

Care management for alcohol dependence with a focus on pharmacotherapy

Alcohol Care Management
Usual CareBEHAVIORAL

Usual care included a referral to a specialty addiction treatment program.

Usual Care

Eligibility Criteria

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

You may qualify if:

  • be men and women = 18 years of age;
  • meet criteria for alcohol dependence;
  • drink more than an average of 2 drinks per day prior to study entry (over the last 60 days);
  • have adequate hearing to participate in assessment

You may not qualify if:

  • show no evidence of current abuse or dependence of illicit substances other than marijuana;
  • no current hallucinations;
  • no current symptoms of mania;
  • be relatively cognitively intact
  • not actively participate in specialized addition or behavioral health treatment within the prior 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210, United States

Location

Philadelphia VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Oslin DW, Lynch KG, Maisto SA, Lantinga LJ, McKay JR, Possemato K, Ingram E, Wierzbicki M. A randomized clinical trial of alcohol care management delivered in Department of Veterans Affairs primary care clinics versus specialty addiction treatment. J Gen Intern Med. 2014 Jan;29(1):162-8. doi: 10.1007/s11606-013-2625-8. Epub 2013 Sep 20.

    PMID: 24052453RESULT

  • Rotenberg JR, Leong SH, Maisto SA, McKay JR, Possemato K, Ingram E, Oslin DW. Post-intervention Durability of Alcohol Care Management: 1-Year Follow-up of a Randomized Controlled Trial. J Gen Intern Med. 2018 Oct;33(10):1626-1628. doi: 10.1007/s11606-018-4567-7. No abstract available.

    PMID: 30003479DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Limitations and Caveats

The data presented in the results does not provide a true measure of the longitudinal effects done with GEE modeling.

Results Point of Contact

Title
David Oslin
Organization
Philadelphia VA Medical Center
dave.oslin@va.gov
215 823 5894

Study Officials

  • David W. Oslin, MD

    Philadelphia VA Medical Center, Philadelphia, PA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 8, 2007

Study Start

August 1, 2007

Primary Completion

March 1, 2011

Study Completion

July 1, 2011

Last Updated

May 12, 2015

Results First Posted

November 11, 2014

Record last verified: 2015-04

Locations

US(2)