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NCT01032135 · ClinicalTrials.gov registry record · Phase 2
Adaptive Treatment for Alcohol and Cocaine Dependence
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 500
- Enrollment target
NCT01032135: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT01032135 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 500 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01032135, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 500 participants
- Enrollment target
Study 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/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 cocaine/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 cocaine/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 cocaine/alcohol 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/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/alcohol 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.
Interventions
- BEHAVIORAL Motivational Interviewing
- BEHAVIORAL Telephone counseling
- BEHAVIORAL Cognitive Behavioral Therapy (CBT) Counseling
- DRUG medication management
- BEHAVIORAL Intensive OutPatient Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2008-10 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01032135
The ClinicalTrials.gov registry entry for NCT01032135 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Motivational Interviewing is the first listed.
NCT01032135 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01032135 about?
NCT01032135 is a clinical study titled "Adaptive Treatment for Alcohol and 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/alcohol use over weeks 1-24. * Hypothesis 1: An intervention that explores several possible treatment options with the patien...
What is the current status of trial NCT01032135?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 500 participants. The study started on 2008-10. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01032135?
The interventions under investigation include: Motivational Interviewing (BEHAVIORAL), Telephone counseling (BEHAVIORAL), Cognitive Behavioral Therapy (CBT) Counseling (BEHAVIORAL), medication management (DRUG), Intensive OutPatient Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01032135?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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