Effectiveness of Extended Telephone Monitoring

Alcohol Dependence Clinical Trial

— ETM  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194103
• Other study ID #: 708753
• Secondary ID: R01AA014850
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: June 25, 2010
• Start date: May 2004
• Est. completion date: April 2010

Study information

• Verified date: June 2010
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: NIH
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: April 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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;

• 4th 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Behavioral:
• Telephone Monitoring and Feedback
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 and Counseling
In addition to attending IOP, participants have phone contact with study counselors, which includes monitoring, feedback, and counseling.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TimeLineFollowBack		2 years	Yes