Effectiveness of Enhanced Treatments for Drug Dependence

University of Pennsylvania150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Cocaine Dependence

Interventions

Telephone Monitoring and Counseling - EnhancedBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Time Line Follow Back

abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 12 month

Data from ClinicalTrials.gov

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