Adaptive Treatment for Alcohol and Cocaine Dependence

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.

Conditions

• Substance Use Disorders

Interventions

BEHAVIORAL

Motivational Interviewing

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

BEHAVIORAL

Telephone counseling

one telephone counseling session per week for 10 weeks.

BEHAVIORAL

Cognitive Behavioral Therapy (CBT) Counseling

One CBT session per week, for 10 weeks.

DRUG

medication management

Prescription for naltrexone

BEHAVIORAL

Intensive OutPatient Therapy

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

Sponsors & Collaborators

• University of Pennsylvania

  lead OTHER

Principal Investigators

• James R. McKay, Ph.D · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-10-31

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• United States

Study Locations