NCT00194103

Brief Summary

The purpose of this study is to determine the effectiveness of extended telephone monitoring for alcohol-dependent patients receiving intensive outpatient treatment. It is hypothesized that telephone monitoring will produce better alcohol use outcomes relative to treatment as usual. It is also hypothesized that adaptive telephone monitoring plus brief counseling will produce better alcohol use outcomes over time relative to telephone monitoring plus feedback only.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2004

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 28, 2010

Status Verified

June 1, 2010

Enrollment Period

5.3 years

First QC Date

September 12, 2005

Last Update Submit

June 25, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • TimeLineFollowBack

    2 years

Study Arms (3)

TAU

NO INTERVENTION

Telephone Monitoring

ACTIVE COMPARATOR
Behavioral: Telephone Monitoring and Feedback

Telephone Monitoring and Counseling

EXPERIMENTAL
Behavioral: Telephone Monitoring and Counseling

Interventions

In addition to attending IOP, participants receive phone contact from our counselors but only to receive a monitoring assessment. There is no feedback or counseling from study staff in this condition.

Telephone Monitoring

In addition to attending IOP, participants have phone contact with study counselors, which includes monitoring, feedback, and counseling.

Telephone Monitoring and Counseling

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • enrolled in Intensive Outpatient substance abuse treatment for at least 2 and no more than 4 weeks at study entry
  • qualify for a current DSM-IV diagnosis of alcohol dependence (during the month prior to entrance into the IOP or detoxification program prior to IOP);
  • willingness to participate in research and be randomized;
  • th grade reading level (as determined by the Slosson Oral Reading Test; Slosson, 1963);
  • able to provide the names of several informants who will know his/her whereabouts during the follow-up period

You may not qualify if:

  • acute medical or psychiatric problems that preclude outpatient treatment (e.g., in a psychotic episode and not stabilized on medication);
  • IV heroin use during the past year;
  • anticipated involvement in other forms of intensive treatment (e.g., inpatient) during the 6-month period after enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Counseling

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • James McKay, Ph. D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

May 1, 2004

Primary Completion

August 1, 2009

Study Completion

April 1, 2010

Last Updated

June 28, 2010

Record last verified: 2010-06

Locations