Adaptive Treatment for Alcohol and Cocaine Dependence

University of Pennsylvania

Status and phase: Completed; Phase 3; Phase 2

Conditions: Substance Use Disorders

Treatments: Behavioral: Telephone counseling; Behavioral: Intensive OutPatient Therapy; Behavioral: Cognitive Behavioral Therapy (CBT) Counseling; Drug: medication management; Behavioral: Motivational Interviewing

Study type: Interventional

Funder types: Other

Identifiers

NCT01032135

IND: 101,486

807092

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. meet DSM-IV criteria for lifetime cocaine or alcohol dependence and have used cocaine or alcohol in the prior 6 months;
2. be > 18 years of age;
3. be judged clinically appropriate for IOP (e.g., no current psychotic disorder or evidence of severe dementia, and no acute medical problem requiring inpatient treatment;
4. have no regular IV heroin use during the past year;
5. have access to a telephone;
6. be willing to be randomized and participate in research; and
7. no current participation in methadone or other forms of DA treatment, other than IOP. Finally, because of study follow-up requirements, subjects will
8. be required to be metropolitan area residents, and
9. be able to provide the name, verified telephone number, and address of at least two contacts who can provide locator information on the patient during follow-up. We will include patients with dependence on other substances, provided that they are cocaine dependent and meet other inclusion criteria.

Exclusion criteria

1. have a current psychotic disorder (as assessed with the psychotic screen from the MINI) or evidence of dementia severe enough to prevent participation in outpatient treatment;
2. have acute medical problem requiring immediate inpatient treatment; or
3. are currently participating in methadone or other forms of DA treatment, other than IOP.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 4 patient groups

1-MI-IOP Engaged

Active Comparator group

Description:

Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization.

Treatment:

Behavioral: Motivational Interviewing

2-MI-IOP Non-Engaged

Experimental group

Description:

Randomized to treatment as usual, and do not attend.

Treatment:

Behavioral: Motivational Interviewing

Drug: medication management

Behavioral: Cognitive Behavioral Therapy (CBT) Counseling

Behavioral: Intensive OutPatient Therapy

Behavioral: Telephone counseling

3-MI-PC Engaged

Active Comparator group

Description:

Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.

Treatment:

Behavioral: Motivational Interviewing

Behavioral: Cognitive Behavioral Therapy (CBT) Counseling

Behavioral: Telephone counseling

4-MI-PC Non-engaged

Experimental group

Description:

Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.

Treatment:

Behavioral: Motivational Interviewing

Drug: medication management

Behavioral: Cognitive Behavioral Therapy (CBT) Counseling

Behavioral: Intensive OutPatient Therapy

Behavioral: Telephone counseling