Adaptive Treatment for Alcohol and Cocaine Dependence
Primary Purpose
Substance Use Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Telephone counseling
Cognitive Behavioral Therapy (CBT) Counseling
medication management
Intensive OutPatient Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders
Eligibility Criteria
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.
Sites / Locations
- Presbyterian Medical Center
- VAMC
- NorthEast Treatment Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Active Comparator
Experimental
Arm Label
1-MI-IOP Engaged
2-MI-IOP Non-Engaged
3-MI-PC Engaged
4-MI-PC Non-engaged
Arm Description
Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization.
Randomized to treatment as usual, and do not attend.
Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
Outcomes
Primary Outcome Measures
Treatment Engagement
Number of treatment sessions attended
Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks
Number of treatment sessions attended
Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks
Number of treatment sessions attended
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.
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.
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.
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.
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.
Percent Days Drinking
Percent days of any drinking at follow up, from Time Line Follow Back
Percent Days Drinking
Percent days of any drinking at follow up, from Time Line Follow Back
Percent Days Drinking
Percent days of any drinking at follow up, from Time Line Follow Back
Percent Days Drinking
Percent days of any drinking at follow up, fromTime Line Follow Back
Percent Days Drinking
Percent days of any drinking at follow up, from Time Line Follow Back
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.
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.
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.
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.
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.
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
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.
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
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
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
Any Cocaine Use
Any cocaine using self report, binary measure of percent days cocaine use.
Any Cocaine Use
Any cocaine using self report, binary measure of percent days cocaine use
Any Cocaine Use
Any cocaine using self report, binary measure of percent days cocaine use
Any Cocaine Use
Any cocaine using self report, binary measure of percent days cocaine use
Percent Days Cocaine Use
Percent days of any cocaine use, self reported
Percent Days Cocaine Use
Percent days of any cocaine use, self reported
Percent Days Cocaine Use
Percent days of any cocaine use, self reported
Secondary Outcome Measures
Full Information
NCT ID
NCT01032135
First Posted
December 14, 2009
Last Updated
August 1, 2017
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01032135
Brief Title
Adaptive Treatment for Alcohol and Cocaine Dependence
Official Title
Adaptive Treatment for Alcohol and Cocaine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1-MI-IOP Engaged
Arm Type
Active Comparator
Arm Description
Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization.
Arm Title
2-MI-IOP Non-Engaged
Arm Type
Experimental
Arm Description
Randomized to treatment as usual, and do not attend.
Arm Title
3-MI-PC Engaged
Arm Type
Active Comparator
Arm Description
Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Arm Title
4-MI-PC Non-engaged
Arm Type
Experimental
Arm Description
Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Other Intervention Name(s)
MI
Intervention Description
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Intervention Type
Behavioral
Intervention Name(s)
Telephone counseling
Other Intervention Name(s)
Telephone based stepped care.
Intervention Description
one telephone counseling session per week for 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT) Counseling
Other Intervention Name(s)
CBT
Intervention Description
One CBT session per week, for 10 weeks.
Intervention Type
Drug
Intervention Name(s)
medication management
Other Intervention Name(s)
MM
Intervention Description
Prescription for naltrexone
Intervention Type
Behavioral
Intervention Name(s)
Intensive OutPatient Therapy
Other Intervention Name(s)
IOP
Intervention Description
Return to IOP, group therapy 3 times weekly for about three hours a day.
Primary Outcome Measure Information:
Title
Treatment Engagement
Description
Number of treatment sessions attended
Time Frame
weeks 3 - 12
Title
Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks
Description
Number of treatment sessions attended
Time Frame
weeks 9 - 12
Title
Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks
Description
Number of treatment sessions attended
Time Frame
weeks 9 - 12
Title
Any Drinking Days in Previous Month
Description
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.
Time Frame
Month 2 (weeks 5 - 8 post baseline)
Title
Any Drinking Days in Previous Month
Description
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.
Time Frame
Month 3 (weeks 9 - 12 post baseline)
Title
Any Drinking
Description
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.
Time Frame
Month 4 (weeks 13 - 15 post baseline)
Title
Any Drinking
Description
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.
Time Frame
Month 5 (weeks 16 - 20 post baseline)
Title
Any Drinking
Description
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.
Time Frame
Month 6 (weeks 21 - 24 post baseline)
Title
Percent Days Drinking
Description
Percent days of any drinking at follow up, from Time Line Follow Back
Time Frame
Month 2 (weeks 5 - 8 post baseline)
Title
Percent Days Drinking
Description
Percent days of any drinking at follow up, from Time Line Follow Back
Time Frame
Month 3 (weeks 9 - 12 post baseline)
Title
Percent Days Drinking
Description
Percent days of any drinking at follow up, from Time Line Follow Back
Time Frame
Month 4 (weeks 13 - 16 post baseline)
Title
Percent Days Drinking
Description
Percent days of any drinking at follow up, fromTime Line Follow Back
Time Frame
Month 5 (weeks 17 - 20 post baseline)
Title
Percent Days Drinking
Description
Percent days of any drinking at follow up, from Time Line Follow Back
Time Frame
Month 6 (weeks 21 - 24)
Title
Any Heavy Drinking Days
Description
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.
Time Frame
Month 2 (weeks 5 - 8 post baseline)
Title
Any Heavy Drinking Days
Description
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.
Time Frame
Month 3 (weeks 9 - 12 post baseline)
Title
Any Heavy Drinking Days
Description
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.
Time Frame
Month 4 (weeks 13 - 16 post baseline)
Title
Any Heavy Drinking Days
Description
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.
Time Frame
Month 5 (weeks 17 to 20 post baseline)
Title
Any Heavy Drinking Days
Description
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.
Time Frame
Month 6 (weeks 21 - 24 post baseline)
Title
Percent Days Heavy Drinking
Description
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
Time Frame
Month 2 (weeks 5 - 8 post baseline)
Title
Percent Days Heavy Drinking
Description
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.
Time Frame
Month 3 (weeks 9 - 12 post baseline)
Title
Percent Days Heavy Drinking
Description
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
Time Frame
Month 4 (weeks 13 - 16 post baseline)
Title
Percent Days Heavy Drinking
Description
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
Time Frame
Month 5 ( weeks 17 - 20 post baseline)
Title
Percent Days Heavy Drinking
Description
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
Time Frame
Month 6 (weeks 21 - 24 post baseline)
Title
Any Cocaine Use
Description
Any cocaine using self report, binary measure of percent days cocaine use.
Time Frame
Month 3 (weeks 9 - 12 post baseline)
Title
Any Cocaine Use
Description
Any cocaine using self report, binary measure of percent days cocaine use
Time Frame
Month 4 (weeks 13 - 16 post baseline)
Title
Any Cocaine Use
Description
Any cocaine using self report, binary measure of percent days cocaine use
Time Frame
Month 5 (weeks 17 - 20 post baseline)
Title
Any Cocaine Use
Description
Any cocaine using self report, binary measure of percent days cocaine use
Time Frame
Month 6 (weeks 21 - 24 post baseline)
Title
Percent Days Cocaine Use
Description
Percent days of any cocaine use, self reported
Time Frame
Month 3 (weeks 9 - 12 post baseline)
Title
Percent Days Cocaine Use
Description
Percent days of any cocaine use, self reported
Time Frame
Month 5 (weeks 17 - 20 post baseline)
Title
Percent Days Cocaine Use
Description
Percent days of any cocaine use, self reported
Time Frame
Month 6 (weeks 21 - 24 post baseline)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R. McKay, Ph.D
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
VAMC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
NorthEast Treatment Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19123
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Adaptive Treatment for Alcohol and Cocaine Dependence
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