NCT00132795

Brief Summary

The purpose of this study is to determine whether a telephone based self-help program will prevent relapse among individuals undergoing standard substance abuse treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2005

Longer than P75 for phase_2

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, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

June 21, 2012

Status Verified

June 1, 2012

Enrollment Period

4.6 years

First QC Date

August 19, 2005

Last Update Submit

June 20, 2012

Conditions

Keywords

Cognitive TherapyRecurrencePreventionEducational Technology

Outcome Measures

Primary Outcomes (1)

  • Amount of alcohol and use

    drinks per day, drinks per drinking day, percent days abstinent, heavy drinking days

    4 months and one year

Secondary Outcomes (1)

  • Utilization of the telephone system components during the study

    4 months and one year

Study Arms (2)

1 Therapeutic Phone System

EXPERIMENTAL

patients assigned to this condition will have unlimited access to the therapeutic telephone system for 4 months.

Behavioral: Daily monitoring of alcohol & drug use, & therapy skills

2 Standard care

ACTIVE COMPARATOR

Standard post-CBT care (i.e., no formal relapse prevention or professional treatment).

Behavioral: control group

Interventions

Comparison(s): patients completing group CBT for substance abuse will be randomly assigned to two conditions. In one condition, patients will have unlimited access to the therapeutic telephone system for 4 months. The other condition is standard care (i.e., no formal relapse prevention).

Also known as: relapse prevention
1 Therapeutic Phone System
control groupBEHAVIORAL

standard care (no added treatment)

2 Standard care

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets current DSM-IV criteria for alcohol dependence
  • Active drinking during the three months prior to entry into treatment
  • Minimum age of 19
  • Minimum sixth grade reading level.

You may not qualify if:

  • Meets criteria for a current psychotic illness
  • Imminent plans to move or be incarcerated
  • Presence of such severe hearing, visual, or cognitive deficit(s) that participation in CBT or use of an Interactive Voice Response (IVR) system are not possible
  • Inability to identify at least one "locator" person to assist in tracking for follow-up assessments
  • Does not have telephone service within the home
  • Incarceration while in active protocol in the study
  • Attendance of less than 8 of 12 CBT sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UVM Health Behavior Research Center

Burlington, Vermont, 05403, United States

Location

Related Links

MeSH Terms

Conditions

AlcoholismRecurrence

Interventions

EthanolSecondary PreventionControl Groups

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsTherapeuticsPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public HealthEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • John E. Helzer, MD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 22, 2005

Study Start

May 1, 2005

Primary Completion

December 1, 2009

Study Completion

July 1, 2010

Last Updated

June 21, 2012

Record last verified: 2012-06

Locations