Cocaine Dependence Clinical Trial
Official title:
Adaptive Treatment for Cocaine Dependence
1. Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the
full study sample with regard to treatment engagement over weeks 1-12 and cocaine use
over weeks 1-24.
- Hypothesis 1: An intervention that explores several possible treatment options
with the patient and provides the chosen option (e.g., MI-PC) will produce higher
rates of treatment engagement than an intervention focused on engagement in IOP
only (e.g., MI-IOP).
- Hypothesis 2: An intervention that explores several possible treatment options
with the patient and provides the chosen option (e.g., MI-PC) will produce better
cocaine use outcomes than an intervention focused on engagement in IOP only
(MI-IOP).
- Secondary analysis 1: Among the Non-engaged patients, determine rates of selection
of each of the three options in MI-PC, retention rates within each option, and
cocaine use outcomes in each option.
- Secondary analysis 2: Among the Engaged patients, determine rates of selection of
each of the three options in MI-PC, retention rates within each option, and
cocaine use outcomes in each option.
2. Primary objective #2: Determine whether the relative effectiveness of MI-IOP and MI-PC
varies as a function of engagement group, with regard to treatment engagement over
weeks 1-12 and cocaine use outcomes over weeks 1-24.
- Hypothesis 1: The predicted main effect on retention favoring MI-PC over MI-IOP
will be significantly larger among patients in the Non-engaged group than among
those in the Engaged group.
- Hypothesis 2: The predicted main effect on cocaine use outcomes favoring MI-PC
over MI-IOP will be significantly larger among patients in the Non-engaged group
than among those in the Engaged group.
3. Secondary objective #1: Examine outcomes on three secondary measures: percent days
abstinent from all substances, negative consequences of drug use, and HIV high risk
behaviors.
- Hypothesis 1: Outcomes on the secondary measures will be better in MI-PC than in
MI-IOP.
4. Secondary objective #2: Test hypotheses concerning potential mediators of the
predicted main effect favoring MI-PC over MI-IOP.
- Hypothesis 1: The predicted advantage of MI-PC over MI-IOP will be mediated by greater
increases in motivation, self-efficacy, commitment to abstinence, and self-help
involvement in MI-PC.
5. Secondary objective #3: Test hypotheses concerning effect of additional MI
intervention after initial non-engagement persists through 12 weeks.
- Hypothesis 1: A second telephone MI intervention will produce higher rates of
subsequent engagement and less cocaine use than no further MI.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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