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

Cocaine Dependence Clinical Trial

Official title:

Effectiveness of Extended Treatment for Drug Dependence - City Supplement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153464
• Other study ID #: 810106
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2010
• Last updated: March 28, 2017
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: March 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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