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Effectiveness of Enhanced Treatments for Drug Dependence (EETDD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01153477
First Posted: June 30, 2010
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose
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.

Condition Intervention Phase
Cocaine Dependence Behavioral: Telephone Monitoring and Counseling - Enhanced Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of an Enhanced Adaptive Continuing Care Model for Cocaine Dependence

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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)

  • 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)

  • 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)

  • 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)


Enrollment: 150
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  • (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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153477


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01153477     History of Changes
Other Study ID Numbers: 810112
First Submitted: June 24, 2010
First Posted: June 30, 2010
Last Update Posted: March 30, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders