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

NCT01153464 | Completed Phase 2

• 1 other identifier: 810106
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Treatment As Usual

NO INTERVENTION

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.

Recovery Support Counseling

EXPERIMENTAL

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

Interventions

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.

Recovery Support Counseling

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: June 30, 2010
• Study Start: October 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)