Effectiveness of Enhanced Treatments for Drug Dependence

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of an Enhanced Adaptive Continuing Care Model for Cocaine Dependence

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Behavioral: Telephone Monitoring and Counseling - Enhanced


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: TAU<br>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)<br>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<br>* 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.<br>|

What is the study measuring?
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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 |