Effectiveness of Enhanced Treatments for Drug Dependence (EETDD)

University of Pennsylvania

Status and phase: Completed; Phase 2

Conditions: Cocaine Dependence

Treatments: Behavioral: Telephone Monitoring and Counseling - Enhanced

Study type: Interventional

Funder types: Other

Identifiers

NCT01153477

810112

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

TAU

No Intervention group

Description:

This group is the control group by which we are comparing our intervention. This group will not receive an intervention from us but will continue to be treated at the Intensive Outpatient facility from which we recruited them.

Counseling (TMAC-E)

Experimental group

Description:

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.

Treatment:

Behavioral: Telephone Monitoring and Counseling - Enhanced