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

NCT ID: NCT01153464

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-09-30

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.

Conditions

Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Recovery Support Counseling

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

810106

Identifier Type: -

Identifier Source: org_study_id