Cocaine Dependence Clinical Trial
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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