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Adaptive Treatment for Cocaine Dependence

2014-08-27 03:17:17 | BioPortfolio

Summary

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.

Description

3. Secondary objective #1: Examine outcomes on three secondary measures: percent days abstinent from all substances, nega¬tive 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.

Study Design

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

Conditions

Cocaine Dependence

Intervention

Motivational Interviewing, Telephone counseling, Cognitive Behavioral Therapy (CBT) Counseling

Location

Presbyterian Medical Center
Philadelphia
Pennsylvania
United States
19104

Status

Recruiting

Source

University of Pennsylvania

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:17-0400

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