Effectiveness of Enhanced Treatments for Drug Dependence

Phase 2

Completed

• Conditions: Cocaine Dependence
• Interventions: Behavioral: Telephone Monitoring and Counseling - Enhanced

• Registration Number: NCT01153477
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-06-24
• Study First Submitted QC: 2010-06-29
• Study First Posted: 2010-06-30
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Counseling (TMAC-E)	Telephone Monitoring and Counseling - Enhanced	This telephone based intervention includes six factors to improve our extended treatment model: Incentive component; Patient choice; Provision of cell phones to those who need them; Social support and community resources; Positive recovery factors; and Outreach following dropout.

Primary Outcome Measures

Name	Time	Method
Time Line Follow Back	12 month	abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States