Back to results

Effectiveness of Enhanced Treatments for Drug Dependence (EETDD)

Primary Purpose

Cocaine Dependence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Telephone Monitoring and Counseling - Enhanced

About this trial

This is an interventional treatment trial for Cocaine Dependence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

TAU

Counseling (TMAC-E)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 Line Follow Back

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

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 Line Follow Back

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01153477

First Posted

June 24, 2010

Last Updated

March 28, 2017

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT01153477

Brief Title

Effectiveness of Enhanced Treatments for Drug Dependence

Acronym

EETDD

Official Title

Effectiveness of an Enhanced Adaptive Continuing Care Model for Cocaine Dependence

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAU

Arm Type

No Intervention

Arm Description

Arm Title

Counseling (TMAC-E)

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Telephone Monitoring and Counseling - Enhanced

Intervention Description

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 Outcome Measure Information:

Title

Time Line Follow Back

Description

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

Time Frame

3 month

Title

Time Line Follow Back

Description

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

Time Frame

6 month

Title

Time Line Follow Back

Description

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

Time Frame

9 month

Title

Time Line Follow Back

Description

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

Time Frame

12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Enhanced Treatments for Drug Dependence

We'll reach out to this number within 24 hrs