Back to resultsEffectiveness of Extended Treatment for Drug Dependence (ETDD) in the City Study
Primary Purpose
Cocaine Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Recovery Support Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Dependence
Eligibility 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.
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Treatment As Usual
Recovery Support Counseling
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Time Line Follow Back
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Time Line Follow Back
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Time Line Follow Back
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Time Line Follow Back
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Secondary Outcome Measures
Full Information
NCT ID
NCT01153464
First Posted
June 24, 2010
Last Updated
March 28, 2017
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01153464
Brief Title
Effectiveness of Extended Treatment for Drug Dependence (ETDD) in the City Study
Official Title
Effectiveness of Extended Treatment for Drug Dependence - City Supplement
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
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.
Arm Title
Recovery Support Counseling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recovery Support Counseling
Intervention Description
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 Outcome Measure Information:
Title
Time Line Follow Back
Description
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Time Frame
3 month
Title
Time Line Follow Back
Description
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Time Frame
6 month
Title
Time Line Follow Back
Description
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Time Frame
9 month
Title
Time Line Follow Back
Description
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Effectiveness of Extended Treatment for Drug Dependence (ETDD) in the City Study
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