Effectiveness of Enhanced Treatments for Drug Dependence - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
abstinence from drug and alcohol use within each 3 month period of the follow-up (as indicated by the TLFB)

Estimated Enrollment:	150
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2011
Estimated 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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153477

Locations

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

Sponsors and Collaborators

University of Pennsylvania

More Information

No publications provided

Responsible Party:	James R. McKay, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT01153477 History of Changes
Other Study ID Numbers:	810112
Study First Received:	June 24, 2010
Last Updated:	August 4, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Substance-Related Disorders
Cocaine-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013

Effectiveness of Enhanced Treatments for Drug Dependence (EETDD)