Effectiveness of Enhanced Treatments for Drug Dependence

NCT01153477 | Completed Phase 2

• 1 other identifier: 810112
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

TAU

NO INTERVENTION

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.

Counseling (TMAC-E)

EXPERIMENTAL

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

Interventions

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.

Counseling (TMAC-E)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: June 30, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)