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OpenTrials
Completed

NCT Number: NCT01153477

Effectiveness of Enhanced Treatments for Drug 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.

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Key information

Conditions

Cocaine Dependence Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telephone Monitoring and Counseling - Enhanced

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.

Primary outcomes

  1. Time Line Follow Back

    Time frame: 3 month

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

  2. Time Line Follow Back

    Time frame: 6 month

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

  3. Time Line Follow Back

    Time frame: 9 month

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

  4. Time Line Follow Back

    Time frame: 12 month

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Effectiveness of an Enhanced Adaptive Continuing Care Model for Cocaine Dependence

Acronym: EETDD

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 30, 2010
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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