Effectiveness of Extended Treatments for Drug Dependence

Cocaine Dependence Clinical Trial

— ETDD  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00685659
• Other study ID #: R01DA020623
• Status: Recruiting
• Phase: Phase 2
• First received: May 23, 2008
• Last updated: May 23, 2008
• Start date: May 2007
• Est. completion date: May 2011

Study information

• Verified date: May 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: Megan Long, MS
• Phone: 215-746-7712
• Email: long_m[@]mail.trc.upenn.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Other:
• Intensive Outpatient Treatment
9 hours of group counseling per week for 2-3 months
• 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
• 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

Locations

Country	Name	City	State
United States	NorthEast Treatment Centers	Philadelphia	Pennsylvania
United States	Presbyterian Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence from cocaine, alcohol, and other drugs.		within each 3 month segment of the follow-up
Secondary	percent days cocaine use		within each 3 month segment of the follow-up