Adaptive Treatment for Alcohol and Cocaine Dependence

Phase 2

Completed

Conditions: Substance Use Disorders

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

Registration Number: NCT01032135

Lead Sponsor: University of Pennsylvania

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 500

Inclusion Criteria

meet DSM-IV criteria for lifetime cocaine or alcohol dependence and have used cocaine or alcohol in the prior 6 months;
be > 18 years of age;
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;
have no regular IV heroin use during the past year;
have access to a telephone;
be willing to be randomized and participate in research; and
no current participation in methadone or other forms of DA treatment, other than IOP. Finally, because of study follow-up requirements, subjects will
be required to be metropolitan area residents, and
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

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;
have acute medical problem requiring immediate inpatient treatment; or
are currently participating in methadone or other forms of DA treatment, other than IOP.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-MI-IOP Non-Engaged	Intensive OutPatient Therapy	Randomized to treatment as usual, and do not attend.
1-MI-IOP Engaged	Motivational Interviewing	Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization.
2-MI-IOP Non-Engaged	Motivational Interviewing	Randomized to treatment as usual, and do not attend.
2-MI-IOP Non-Engaged	Telephone counseling	Randomized to treatment as usual, and do not attend.
2-MI-IOP Non-Engaged	Cognitive Behavioral Therapy (CBT) Counseling	Randomized to treatment as usual, and do not attend.
2-MI-IOP Non-Engaged	medication management	Randomized to treatment as usual, and do not attend.
3-MI-PC Engaged	Motivational Interviewing	Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
3-MI-PC Engaged	Telephone counseling	Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
3-MI-PC Engaged	Cognitive Behavioral Therapy (CBT) Counseling	Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
4-MI-PC Non-engaged	Motivational Interviewing	Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
4-MI-PC Non-engaged	Telephone counseling	Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
4-MI-PC Non-engaged	Cognitive Behavioral Therapy (CBT) Counseling	Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
4-MI-PC Non-engaged	medication management	Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
4-MI-PC Non-engaged	Intensive OutPatient Therapy	Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.

Primary Outcome Measures

Name	Time	Method
Treatment Engagement	weeks 3 - 12	Number of treatment sessions attended
Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks	weeks 9 - 12	Number of treatment sessions attended
Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks	weeks 9 - 12	Number of treatment sessions attended
Any Drinking Days in Previous Month	Month 3 (weeks 9 - 12 post baseline)	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.
Percent Days Drinking	Month 6 (weeks 21 - 24)	Percent days of any drinking at follow up, from Time Line Follow Back
Any Drinking	Month 6 (weeks 21 - 24 post baseline)	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.
Percent Days Heavy Drinking	Month 6 (weeks 21 - 24 post baseline)	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
Any Heavy Drinking Days	Month 6 (weeks 21 - 24 post baseline)	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.
Any Cocaine Use	Month 6 (weeks 21 - 24 post baseline)	Any cocaine using self report, binary measure of percent days cocaine use
Percent Days Cocaine Use	Month 6 (weeks 21 - 24 post baseline)	Percent days of any cocaine use, self reported

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (3): Presbyterian Medical Center
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Philadelphia, Pennsylvania, United States
VAMC
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Philadelphia, Pennsylvania, United States
NorthEast Treatment Center
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Philadelphia, Pennsylvania, United States