CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 500 enrolled
Drug / intervention
medication management +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01032135
NCT01032135Phase 3Completed

Adaptive Treatment for Alcohol and Cocaine Dependence

University of Pennsylvania·interventional·Posted Dec 15, 2009·Updated Sep 5, 2017

In Brief

A Phase 3 clinical trial evaluating Motivational Interviewing, Telephone counseling, and 3 other interventions for Substance Use Disorders. Completed, enrolled 500 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2009
Enrollment StartOct 1, 2008
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 16.5 years ago

Interventions

Motivational Interviewingbehavioral

2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.

Telephone counselingbehavioral

one telephone counseling session per week for 10 weeks.

Cognitive Behavioral Therapy (CBT) Counselingbehavioral

One CBT session per week, for 10 weeks.

medication managementdrug

Prescription for naltrexone

Intensive OutPatient Therapybehavioral

Return to IOP, group therapy 3 times weekly for about three hours a day.