Adaptive Treatment for Alcohol Dependence

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02689674
Study type	Interventional
Source	University of Pennsylvania
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	February 2009
Completion date	December 2013

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