Effectiveness of Extended Treatments for Drug Dependence (ETDD)

University of Pennsylvania

Status: Completed

Conditions: Cocaine Dependence

Treatments: Other: Adaptive telephone-based counseling plus incentives; Other: Adaptive telephone-based counseling; Other: Intensive Outpatient Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00685659

R01DA020623 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 332 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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332 participants in 3 patient groups

TAU only

Active Comparator group

Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Treatment:

Other: Intensive Outpatient Treatment

TMAC only

Experimental group

Description:

Adaptive telephone-based counseling

Treatment:

Other: Adaptive telephone-based counseling

TMAC plus

Experimental group

Description:

Adaptive telephone-based counseling, plus incentives

Treatment:

Other: Adaptive telephone-based counseling plus incentives