Adaptive Treatment for Alcohol and Cocaine Dependence

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 Overview

• Status: Completed
• Conditions: Substance Use Disorders
• Intervention / Treatment: Behavioral: Motivational Interviewing; Behavioral: Telephone counseling; Behavioral: Cognitive Behavioral Therapy (CBT) Counseling; Drug: medication management; Behavioral: Intensive OutPatient Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Presbyterian Medical Center
    • Philadelphia, Pennsylvania, United States, 19123
      • NorthEast Treatment Center
    • Philadelphia, Pennsylvania, United States, 19104
      • VAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1-MI-IOP Engaged; Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization.	Behavioral: Motivational Interviewing; 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.; Other Names: MI
Experimental: 2-MI-IOP Non-Engaged; Randomized to treatment as usual, and do not attend.	Behavioral: Motivational Interviewing; 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.; Other Names: MI; Behavioral: Telephone counseling; one telephone counseling session per week for 10 weeks.; Other Names: Telephone based stepped care.; Behavioral: Cognitive Behavioral Therapy (CBT) Counseling; One CBT session per week, for 10 weeks.; Other Names: CBT; Drug: medication management; Prescription for naltrexone; Other Names: MM; Behavioral: Intensive OutPatient Therapy; Return to IOP, group therapy 3 times weekly for about three hours a day.; Other Names: IOP
Active Comparator: 3-MI-PC Engaged; Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.	Behavioral: Motivational Interviewing; 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.; Other Names: MI; Behavioral: Telephone counseling; one telephone counseling session per week for 10 weeks.; Other Names: Telephone based stepped care.; Behavioral: Cognitive Behavioral Therapy (CBT) Counseling; One CBT session per week, for 10 weeks.; Other Names: CBT
Experimental: 4-MI-PC Non-engaged; Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.	Behavioral: Motivational Interviewing; 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.; Other Names: MI; Behavioral: Telephone counseling; one telephone counseling session per week for 10 weeks.; Other Names: Telephone based stepped care.; Behavioral: Cognitive Behavioral Therapy (CBT) Counseling; One CBT session per week, for 10 weeks.; Other Names: CBT; Drug: medication management; Prescription for naltrexone; Other Names: MM; Behavioral: Intensive OutPatient Therapy; Return to IOP, group therapy 3 times weekly for about three hours a day.; Other Names: IOP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Engagement	Number of treatment sessions attended	weeks 3 - 12
Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks	Number of treatment sessions attended	weeks 9 - 12
Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks	Number of treatment sessions attended	weeks 9 - 12
Any Drinking Days in Previous Month	Days of any drinking in previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.	Month 2 (weeks 5 - 8 post baseline)
Any Drinking Days in Previous Month	Any drinking days during previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.	Month 3 (weeks 9 - 12 post baseline)
Any Drinking	Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.	Month 4 (weeks 13 - 15 post baseline)
Any Drinking	Any drinking at follow up, as reported on Time Line Follow Back, This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.	Month 5 (weeks 16 - 20 post baseline)
Any Drinking	Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.	Month 6 (weeks 21 - 24 post baseline)
Percent Days Drinking	Percent days of any drinking at follow up, from Time Line Follow Back	Month 2 (weeks 5 - 8 post baseline)
Percent Days Drinking	Percent days of any drinking at follow up, from Time Line Follow Back	Month 3 (weeks 9 - 12 post baseline)
Percent Days Drinking	Percent days of any drinking at follow up, from Time Line Follow Back	Month 4 (weeks 13 - 16 post baseline)
Percent Days Drinking	Percent days of any drinking at follow up, fromTime Line Follow Back	Month 5 (weeks 17 - 20 post baseline)
Percent Days Drinking	Percent days of any drinking at follow up, from Time Line Follow Back	Month 6 (weeks 21 - 24)
Any Heavy Drinking Days	days of five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.	Month 2 (weeks 5 - 8 post baseline)
Any Heavy Drinking Days	five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.	Month 3 (weeks 9 - 12 post baseline)
Any Heavy Drinking Days	five or more drinks per drinking day for men, four or more drinks per drinking day for women at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.	Month 4 (weeks 13 - 16 post baseline)
Any Heavy Drinking Days	five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.	Month 5 (weeks 17 to 20 post baseline)
Any Heavy Drinking Days	five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.	Month 6 (weeks 21 - 24 post baseline)
Percent Days Heavy Drinking	Percent days heavy drinking at follow up, from Time Line Follow Back *heavy drinking is defined as five or more drinks per day for men, four or more for women	Month 2 (weeks 5 - 8 post baseline)
Percent Days Heavy Drinking	Percent days heavy drinking at follow up, from Time Line Follow Back * heavy drinking is defined as five or more drinks per day for men, four or more for women.	Month 3 (weeks 9 - 12 post baseline)
Percent Days Heavy Drinking	Percent days heavy drinking at follow up, from Time Line Follow Back *heavy drinking is defined as five or more drinks per drinking day for men, four or more for women	Month 4 (weeks 13 - 16 post baseline)
Percent Days Heavy Drinking	Percent days heavy drinking at follow up, from Time Line Follow Back * heavy drinking is defined as five or more drinks per drinking day for men, four or more for women	Month 5 ( weeks 17 - 20 post baseline)
Percent Days Heavy Drinking	Percent days heavy drinking at follow up, from Time Line Follow Back *heavy drinking is defined as five or more drinks per drinking day for men, four or more for women	Month 6 (weeks 21 - 24 post baseline)
Any Cocaine Use	Any cocaine using self report, binary measure of percent days cocaine use.	Month 3 (weeks 9 - 12 post baseline)
Any Cocaine Use	Any cocaine using self report, binary measure of percent days cocaine use	Month 4 (weeks 13 - 16 post baseline)
Any Cocaine Use	Any cocaine using self report, binary measure of percent days cocaine use	Month 5 (weeks 17 - 20 post baseline)
Any Cocaine Use	Any cocaine using self report, binary measure of percent days cocaine use	Month 6 (weeks 21 - 24 post baseline)
Percent Days Cocaine Use	Percent days of any cocaine use, self reported	Month 3 (weeks 9 - 12 post baseline)
Percent Days Cocaine Use	Percent days of any cocaine use, self reported	Month 5 (weeks 17 - 20 post baseline)
Percent Days Cocaine Use	Percent days of any cocaine use, self reported	Month 6 (weeks 21 - 24 post baseline)

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: James R. McKay, Ph.D, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Actual): September 5, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Cocaine-Related Disorders
• Other Study ID Numbers: 807092; IND: 101,486