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

May 23, 2008
May 23, 2008
May 2007
Not Provided
Abstinence from cocaine, alcohol, and other drugs. [ Time Frame: within each 3 month segment of the follow-up ]
Same as current
No Changes Posted
percent days cocaine use [ Time Frame: within each 3 month segment of the follow-up ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Extended Treatments for Drug Dependence
Not Provided

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cocaine Dependence
  • Other: Intensive Outpatient Treatment
    9 hours of group counseling per week for 2-3 months
  • 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
  • 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
  • Active Comparator: 1
    Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)
    Intervention: Other: Intensive Outpatient Treatment
  • Experimental: 2
    Adaptive telephone-based counseling
    Intervention: Other: Adaptive telephone-based counseling
  • Experimental: 3
    Adaptive telephone-based counseling, plus incentives
    Intervention: Other: Adaptive telephone-based counseling plus incentives
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
340
May 2011
Not Provided

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
Both
18 Years to 75 Years
No
Contact: Megan Long, MS 215-746-7712 long_m@mail.trc.upenn.edu
United States
 
NCT00685659
R01DA020623
No
Not Provided
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: James R McKay, Ph.D. University of Pennsylvania
National Institute on Drug Abuse (NIDA)
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP