Adaptive Treatment for Alcohol and Cocaine Dependence
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Motivational Interviewing; Telephone counseling; Cognitive Behavioral Therapy (CBT) Counseling; medication management; Intensive OutPatient Therapy
Intervention type(s): Behavioral; Behavioral; Behavioral; Drug; Behavioral
Intervention description(s): 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.; one telephone counseling session per week for 10 weeks.; One CBT session per week, for 10 weeks.; Prescription for naltrexone; Return to IOP, group therapy 3 times weekly for about three hours a day.
Other intervention name(s): MI; Telephone based stepped care.; CBT; MM; IOP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment