Effectiveness of Enhanced Treatments for Drug Dependence

NCT ID: NCT01153477

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-10-31

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.

Conditions

Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAU

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Counseling (TMAC-E)

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.

Group Type: EXPERIMENTAL

Telephone Monitoring and Counseling - Enhanced

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

810112

Identifier Type: -

Identifier Source: org_study_id