Effectiveness of Enhanced Treatments for Drug Dependence (EETDD)

Effectiveness of an Enhanced Adaptive Continuing Care Model for Cocaine Dependence

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.

Study Overview

• Status: Completed
• Conditions: Cocaine Dependence
• Intervention / Treatment: Behavioral: Telephone Monitoring and Counseling - Enhanced

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 24, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (Estimate): June 30, 2010

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Cocaine-Related Disorders
• Other Study ID Numbers: 810112