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

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Extended Treatment for Drug Dependence - City Supplement

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Behavioral: Recovery Support Counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment As Usual<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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