NCT00278447

Brief Summary

The objective of this study is to test whether a chronic disease management (CDM) program for substance abusers in primary care leads to improved alcohol and drug-related outcomes (such as reduced consumption and health problems) and health care utilization patterns.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
569

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2006

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

First Submitted

Initial submission to the registry

January 13, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

October 2, 2014

Status Verified

October 1, 2012

Enrollment Period

3.8 years

First QC Date

January 13, 2006

Last Update Submit

October 1, 2014

Conditions

Alcohol DependenceAlcoholismDrug Dependence

Keywords

AlcoholAlcohol useAlcohol dependenceDrugDrug useDrug dependenceUtilizationHospitalizationPrimary careChronic disease managementCare managementComorbidity

Outcome Measures

Primary Outcomes (4)

  • Alcohol and drug use

    3, 6, and 12 months after baseline

  • Alcohol and drug-related problems

    3, 6, and 12 months after baseline

  • Nights Hospitalized

    3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled

  • Emergency department visits

    3, 6, and 12 months after baseline and up to 2 years after the last subject is enrolled

Secondary Outcomes (6)

  • Health-related quality of life

    3, 6, and 12 months after baseline

  • Readiness to change

    3, 6, and 12 months after baseline

  • Medical comorbidity

    3, 6, and 12 months after baseline

  • Psychiatric comorbidity

    3, 6, and 12 months after baseline

  • HIV risk behaviors

    3, 6, and 12 months after baseline

  • +1 more secondary outcomes

Study Arms (2)

1) CDM

ACTIVE COMPARATOR

Chronic Disease Management

Behavioral: Chronic Disease Management for substance abuse

2) Standard care

ACTIVE COMPARATOR

Standard care

Behavioral: Standard care

Interventions

Chronic Disease Management for substance abuseBEHAVIORAL

Referral to primary medical care \& longitudinal, multidisciplinary care for persons with substance dependence.

1) CDM
Standard careBEHAVIORAL

Referral to primary medical care for persons with substance dependence.

2) Standard care

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
  • Alcohol or drug dependent
  • Heavy drinking in the past 30 days or recent drug use
  • 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)

You may not qualify if:

  • Pregnant (self-report)
  • Breath alcohol \>100 mg/dL
  • Inability to provide informed consent determined by trained research associates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center / Boston University

Boston, Massachusetts, 02118, United States

Location

Related Publications (4)

  • Park TW, Samet JH, Cheng DM, Winter MR, Kim TW, Fitzgerald A, Saitz R. The prescription of addiction medications after implementation of chronic care management for substance dependence in primary care. J Subst Abuse Treat. 2015 May;52:17-23. doi: 10.1016/j.jsat.2014.11.008. Epub 2014 Dec 2.

    PMID: 25524751DERIVED

  • Park TW, Cheng DM, Samet JH, Winter MR, Saitz R. Chronic care management for substance dependence in primary care among patients with co-occurring disorders. Psychiatr Serv. 2015 Jan 1;66(1):72-9. doi: 10.1176/appi.ps.201300414. Epub 2014 Nov 17.

    PMID: 25219686DERIVED

  • Saitz R, Cheng DM, Winter M, Kim TW, Meli SM, Allensworth-Davies D, Lloyd-Travaglini CA, Samet JH. Chronic care management for dependence on alcohol and other drugs: the AHEAD randomized trial. JAMA. 2013 Sep 18;310(11):1156-67. doi: 10.1001/jama.2013.277609.

    PMID: 24045740DERIVED

  • D'Amore MM, Cheng DM, Allensworth-Davies D, Samet JH, Saitz R. Disparities in safe sex counseling & behavior among individuals with substance dependence: a cross-sectional study. Reprod Health. 2012 Dec 31;9:35. doi: 10.1186/1742-4755-9-35.

    PMID: 23276300DERIVED

MeSH Terms

Conditions

AlcoholismSubstance-Related DisordersAlcohol DrinkingPatient Acceptance of Health Care

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Richard Saitz, MD, MPH

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 18, 2006

Study Start

April 1, 2006

Primary Completion

January 1, 2010

Study Completion

April 1, 2012

Last Updated

October 2, 2014

Record last verified: 2012-10

Locations

US(1)