Clinical trial NCT01032135
Conditions: Substance Use Disorders
Sponsor: University of Pennsylvania
Start date: 2008-10-01; Completion date: 2013-12-01
Enrollment: 500 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
3\. Secondary objective #1: Examine outcomes on three secondary measures: percent days abstinent from all substances, negative 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.

Arms: arm 1: Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization. arm 2: Randomized to treatment as usual, and do not attend. arm 3: Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization. arm 4: Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
Interventions: intervention 1: Motivational Interviewing intervention 2: Telephone counseling intervention 3: Cognitive Behavioral Therapy (CBT) Counseling intervention 4: medication management intervention 5: Intensive OutPatient Therapy
Intervention descriptions: intervention 1: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. intervention 2: one telephone counseling session per week for 10 weeks. intervention 3: One CBT session per week, for 10 weeks. intervention 4: Prescription for naltrexone intervention 5: Return to IOP, group therapy 3 times weekly for about three hours a day.

Protocol documents: