Alcohol Dependence Clinical Trial
Official title:
Adaptive Treatment for Alcohol Dependence
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 alcohol 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 alcohol 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 alcohol 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 alcohol use outcomes in
each option.
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 alcohol 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, nega¬tive consequences of alcohol 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 alcohol use than no further MI.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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