Effectiveness of Extended Treatments for Drug Dependence (ETDD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00685659
First received: May 23, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

This study tests the effectiveness of two 24 month, telephone-based adaptive continuing care interventions for patients with cocaine dependence. The two interventions are predicted to produce better drug use outcomes than standard care. Furthermore, the intervention that also includes monetary incentives for continued participation is hypothesized to produce better retention and drug use outcomes than the intervention without incentives. Economic analyses will determine the cost-effectiveness and benefit-cost of the interventions relative to standard care, and to each other.


Condition Intervention Phase
Cocaine Dependence
Other: Intensive Outpatient Treatment
Other: Adaptive telephone-based counseling
Other: Adaptive telephone-based counseling plus incentives
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Abstinence from cocaine, alcohol, and other drugs. [ Time Frame: within each 3 month segment of the follow-up ]

Secondary Outcome Measures:
  • percent days cocaine use [ Time Frame: within each 3 month segment of the follow-up ]

Estimated Enrollment: 340
Study Start Date: May 2007
Estimated Study Completion Date: May 2011
Arms Assigned Interventions
Active Comparator: 1
Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
Other: Intensive Outpatient Treatment
9 hours of group counseling per week for 2-3 months
Experimental: 2
Adaptive telephone-based counseling
Other: Adaptive telephone-based counseling
In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included
Experimental: 3
Adaptive telephone-based counseling, plus incentives
Other: Adaptive telephone-based counseling plus incentives
In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Detailed Description:

There is considerable evidence that treatment for drug use disorders can lead to substantial improvements in substance use and psychosocial problem severity. However, a significant percentage of patients relapse to problematic levels of substance use after primary treatment, and require additional treatment episodes. Patients are therefore frequently referred to continuing care programs to prevent relapse and decrease the probability of additional rehabilitation treatments. However, current models of continuing care may not be adequate for the long-term management of a chronic, relapsing disorder such as substance dependence. One possible approach for improving the management of drug dependence is adaptive treatment regimes, which combine low intensity monitoring and counseling when patients are doing well with stepped care protocols to increase the intensity of treatment when warranted by deteriorations in status and functioning. However, addiction management protocols may require incentives and other features to make long-term participation more appealing.

Cocaine dependent patients who have completed 2 weeks of intensive outpatient treatment (IOP) will be randomly assigned to one of the following interventions: (1) continued participation in IOP without additional intervention (TAU); (2) TAU plus an adaptive protocol that includes monitoring, feedback, and brief counseling via telephone on a tapered schedule out to 24 months, and more intensive face-to-face treatment when warranted (TMAC); or (3) TAU and the adaptive protocol, plus incentives for sustained participation (TMAC-Plus). Patients will be followed up at 3, 6, 9, 12, 18, and 24 months post intake into the study. Follow-up assessments will include measures of drug use, treatment process and potential mediating factors, psychosocial problem severity, utilization of health and social services, and costs.

The two adaptive extended interventions (TMAC and TMAC-Plus) are predicted to produce better drug use outcomes than TAU. TMAC-Plus is hypothesized to produce better retention and drug use outcomes than TMAC. Economic analyses will determine the cost-effectiveness and benefit-cost of TMAC and TMF-Plus relative to TAU, and to each other. Other analyses will test mediation hypotheses, examine potential moderator effects, and test the impact of disease management on HIV risk behaviors.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • qualify for a DSM-IV lifetime diagnosis of cocaine dependence and cocaine use in 6 months prior to treatment;
  • initial engagement in IOP, as indicated by attendance at 4 or more sessions in the first two weeks of treatment;
  • 18 to 75 years of age;
  • willingness to be randomized and participate in research.
  • metropolitan area residents;
  • 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.

Exclusion Criteria:

  • current psychotic disorder or evidence of dementia severe enough to prevent participation in outpatient treatment;
  • acute medical problem requiring immediate inpatient treatment;
  • current participation in methadone or other forms of DA treatment, other than IOP
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685659

Contacts
Contact: Megan Long, MS 215-746-7712 long_m@mail.trc.upenn.edu

Locations
United States, Pennsylvania
Presbyterian Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: James R McKay, Ph.D.         
NorthEast Treatment Centers Recruiting
Philadelphia, Pennsylvania, United States
Principal Investigator: James R McKay, Ph.D.         
Sponsors and Collaborators
Investigators
Principal Investigator: James R McKay, Ph.D. University of Pennsylvania
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00685659     History of Changes
Other Study ID Numbers: R01DA020623
Study First Received: May 23, 2008
Last Updated: May 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence
treatment
continuing care
outcomes
incentives
adaptive

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

ClinicalTrials.gov processed this record on October 19, 2014