Effectiveness of Extended Treatment for Drug Dependence (ETDD) in the City Study

March 28, 2017 updated by: University of Pennsylvania

Effectiveness of Extended Treatment for Drug Dependence - City Supplement

This protocol (a supplement to 805466) is to test whether our telephone continuing care model can be implemented successfully by "real world" publicly funded programs. Participants will be recruited from Philadelphia's Department of Behavioral Health - run drug programs. The investigators will train city telephone care managers to deliver our telephone continuing care intervention to patients in this program. The investigators will randomize 200 to receive this intervention or usual care and follow them for 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • (1) qualify for a DSM-IV diagnosis of cocaine dependence, with cocaine use in the 6 months prior to entrance into the City of Philadelphia Department of Behavioral Health facilities or controlled environment;
  • (2) 18 to 75 years of age;
  • (3) no current psychotic disorder (as assessed with the psychotic screen from the SCID) or evidence of dementia severe enough to prevent participation in outpatient treatment;
  • (4) no acute medical problem requiring immediate inpatient treatment;
  • (5) no current participation in methadone or other modes of Drug and Alcohol treatment, other than an Intensive Outpatient Program;
  • (6) willingness to be randomized and participate in research.
  • (7) Finally, because of study follow-up requirements, subjects will be able to provide the name, verified telephone number, and address of at least two contacts who can provide locating information on the patient during follow-up. We will include patients with dependence on other substances, provided that they are cocaine dependent and meet other inclusion criteria.

Exclusion Criteria:

  • Current dependence on opiates is an exclusion as those participants may be better served as part of a methadone program rather than a telephone based therapy protocol. Also, if patients are court-ordered to treatment, or otherwise considered prisoners, they will not be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Treatment As Usual
In this arm, participants are not provided any intervention through the study, they are just followed for research purposes at 3m, 6m, 9m, and 12m post baseline as the comparison group.
EXPERIMENTAL: Recovery Support Counseling
This group is eligible to receive the telephone based recovery support counseling from paraprofessionals based out of the City of Philadelphia's Department of Behavioral Health.
Behavioral: Recovery Support Counseling
Telephone based recovery support provided by paraprofessionals at the City of Philadelphia's Behavioral Health Department. Calls are once weekly for 8 weeks, then step down to every other week for the remainder of the year of study participation. Call frequency can be increased as a result of a rise in risk factor/protective factor ratio.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Line Follow Back
Time Frame: 3 month
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
3 month
Time Line Follow Back
Time Frame: 6 month
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
6 month
Time Line Follow Back
Time Frame: 9 month
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
9 month
Time Line Follow Back
Time Frame: 12 month
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

June 24, 2010

First Submitted That Met QC Criteria

June 29, 2010

First Posted (ESTIMATE)

June 30, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 810106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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