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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01153464
First received: June 24, 2010
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Cocaine Dependence
Behavioral: Recovery Support Counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Extended Treatment for Drug Dependence - City Supplement

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Time Line Follow Back [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)

  • Time Line Follow Back [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)

  • Time Line Follow Back [ Time Frame: 9 month ] [ Designated as safety issue: No ]
    abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)

  • Time Line Follow Back [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)


Estimated Enrollment: 200
Study Start Date: October 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01153464

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: James R McKay, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01153464     History of Changes
Other Study ID Numbers: 810106
Study First Received: June 24, 2010
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014