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Completed

NCT Number: NCT01153464

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

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.

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Key information

Conditions

Cocaine Dependence Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recovery Support Counseling

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Effectiveness of Extended Treatment for Drug Dependence - City Supplement

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 30, 2010
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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