Effectiveness of Enhanced Treatments for Drug Dependence

Cocaine Dependence Clinical Trial

— EETDD  

Official title:

Effectiveness of an Enhanced Adaptive Continuing Care Model for Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153477
• Other study ID #: 810112
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2010
• Last updated: March 28, 2017
• Start date: October 2009
• Est. completion date: October 2011

Study information

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

Clinical Trial Summary

The purpose of this challenge grant is to conduct an initial test of a new, enhanced version of this protocol (telephone monitoring and counseling - enhanced, or TMAC-E), which has been modified to include the elements of our existing continuing care intervention plus patient-centered changes to boost patient involvement and community linkages. The investigators will recruit 150 cocaine dependent patients in publicly funded, community-based programs and randomize them to treatment as usual or the TMAC-E and follow them for 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2011
• Est. primary completion date: October 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 some cocaine use in the prior 6 months;

• (2) be 18 to 75 years of age;

• (3) have no current psychotic disorder or evidence of dementia severe enough to prevent participation in outpatient treatment;

• (4) have no acute medical problem requiring immediate inpatient treatment;

• (5) not be in methadone or other modes of Drug and Alcohol treatment, other than Intensive Outpatient Program;

• (6) be willing to be randomized and participate in research;

• (7) because of study follow-up requirements, subjects will be able to provide the name, verified telephone number, and address of at least one contact who can provide locator 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:

• have a current psychotic disorder or evidence of dementia severe enough to prevent participation in outpatient treatment;

• have acute medical problem requiring immediate inpatient treatment;

• are in methadone or other modes of DA treatment, other than IOP;

• or cannot provide names of people who can get messages to them for follow up, in the event we cannot locate the participant at their original address and number. Also, if they are court mandated to treatment or otherwise considered a prisoner, they will be ineligible for the study as we have not applied for Subpart C approval.

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Behavioral:
• Telephone Monitoring and Counseling - Enhanced
Calls or in-person sessions, 1x weekly for first 8 weeks, then every other week up to a year. Step up session frequency if needed based on participants' ratio of protective and risk factors.

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