| ID | Type | Description | Link |
|---|---|---|---|
| IND: 101,486 |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-MI-IOP Engaged | Active Comparator | Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization. |
|
| 2-MI-IOP Non-Engaged | Experimental | Randomized to treatment as usual, and do not attend. |
|
| 3-MI-PC Engaged | Active Comparator | Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization. |
|
| 4-MI-PC Non-engaged | Experimental | Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing | Behavioral | 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James R. McKay, Ph.D | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States | ||
| VAMC |
All participants were enrolled when they entered IOP treatment. We collected baseline measures and monitored their treatment attendance. At 2 weeks, we determined whether they were engaged or nonengaged and randomized all participants at that time. Only those that were nonengaged at week 2 and still nonengaged at week 8 were rerandomized at week 8.
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| ID | Title | Description |
|---|---|---|
| FG000 | Engaged | Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention. |
| FG001 | MI-PC Non-engaged at 2 Weeks | Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice: Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. Telephone counseling: one telephone counseling session per week for 10 weeks. Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks. Medication management: Prescription for naltrexone Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day. |
| FG002 | MI-IOP Non-Engaged at 2 Weeks | Participants begin at IOP, but at 2 weeks are determined to no longer be engaged. Randomized to IOP Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. |
| FG003 | MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks | Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization. Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants. Telephone counseling: one telephone counseling session per week for 10 weeks. Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks. Medication Management: Prescription for Naltrexone |
| FG004 | MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks | Initially engaged at IOP, but become nonengaged in weeks 3 - 8. Motivational Interviewing: 2 sessions at time of disengagement. Return to IOP therapy 3 times weekly for three hours a day |
| FG005 | MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks | Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice. Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants. Telephone counseling: one telephone counseling session per week for 10 weeks. Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks. Medication Management: Prescription for Naltrexone |
| FG006 | No Further Intervention | Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2 Week Randomization |
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| 8 Week Randomization |
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| ID | Title | Description |
|---|---|---|
| BG000 | Engaged | Participants began treatment in IOP, consistently remained engaged in IOP throughout the study time period. This group did not reach the threshold of needing study intervention. |
| BG001 | MI-PC Non-Engaged |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Engagement | Number of treatment sessions attended | Posted | Mean | Standard Deviation | treatment days | weeks 3 - 12 |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Engaged | Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalizations | General disorders | Non-systematic Assessment | The SAEs reported ranged from suicide attempts and depression, to detox and overdose, to migraines. The SAEs were found from searches of electronic medical records and were not study related. The participants were not receiving interventions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James McKay, PhD | University of Pennsylvania | 215-746-7704 | jimrache@mail.med.upenn.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D015928 | Cognitive Behavioral Therapy |
| D003376 | Counseling |
| D054539 | Medication Therapy Management |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
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|
| Telephone counseling | Behavioral | one telephone counseling session per week for 10 weeks. |
|
|
| Cognitive Behavioral Therapy (CBT) Counseling | Behavioral | One CBT session per week, for 10 weeks. |
|
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| medication management | Drug | Prescription for naltrexone |
|
|
| Intensive OutPatient Therapy | Behavioral | Return to IOP, group therapy 3 times weekly for about three hours a day. |
|
|
| 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) |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| NorthEast Treatment Center | Philadelphia | Pennsylvania | 19123 | United States |
| 12 Week Follow up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Participants began treatment in IOP but were not engaged at week 2. Randomized to receive patient choice.
Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling: one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.
medication management: Prescription for naltrexone
Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.
| BG002 | MI-IOP Non-Engaged | Participants began treatment in IOP but were not engaged at week 2. Randomized back to IOP. Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. |
| BG003 | MI-PC Engaged at 2 Weeks, Non-engaged Before 8 Weeks | Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized to Patient Choice. Motivational Interviewing: 2 sessions at week 2. Telephone counseling: one telephone counseling session per week for 10 weeks. Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks. medication management: Prescription for naltrexone Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day. |
| BG004 | MI-IOP Engaged at 2 Weeks, Non-engaged Before 8 Weeks | Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized back to IOP. Motivational Interviewing: 2 sessions at week 2. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG002 | MI-IOP Non-Engaged at 2 Weeks | Participants begin at IOP, but at 2 weeks are determined to no longer be engaged. Randomized to IOP Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. |
| OG003 | MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks | Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization. Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants. Telephone counseling: one telephone counseling session per week for 10 weeks. Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks. Medication Management: Prescription for Naltrexone |
| OG004 | MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks | Initially engaged at IOP, but become nonengaged in weeks 3 - 8. Motivational Interviewing: 2 sessions at time of disengagement. Return to IOP therapy 3 times weekly for three hours a day |
| OG005 | MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks | Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice. Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants. Telephone counseling: one telephone counseling session per week for 10 weeks. Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks. Medication Management: Prescription for Naltrexone |
| OG006 | No Further Intervention | Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention. |
|
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| Primary | Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks | Number of treatment sessions attended | Posted | Mean | Standard Deviation | treatment days | weeks 9 - 12 |
|
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| Primary | Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks | Number of treatment sessions attended | Posted | Mean | Standard Deviation | treatment days | weeks 9 - 12 |
|
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| Primary | 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. | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | proportion of participants | Month 2 (weeks 5 - 8 post baseline) |
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| Primary | 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. | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | proportion of participants | Month 3 (weeks 9 - 12 post baseline) |
|
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| Primary | 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. | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | proportion of participants | Month 4 (weeks 13 - 15 post baseline) |
|
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| Primary | 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. | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | proportion of participants | Month 5 (weeks 16 - 20 post baseline) |
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| Primary | 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. | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | proportion of participants | Month 6 (weeks 21 - 24 post baseline) |
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| Primary | Percent Days Drinking | Percent days of any drinking at follow up, from Time Line Follow Back | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | percentage of days | Month 2 (weeks 5 - 8 post baseline) |
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| Primary | Percent Days Drinking | Percent days of any drinking at follow up, from Time Line Follow Back | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | percentage of days | Month 3 (weeks 9 - 12 post baseline) |
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| Primary | Percent Days Drinking | Percent days of any drinking at follow up, from Time Line Follow Back | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | percentage of days | Month 4 (weeks 13 - 16 post baseline) |
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| Primary | Percent Days Drinking | Percent days of any drinking at follow up, fromTime Line Follow Back | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | percentage of days | Month 5 (weeks 17 - 20 post baseline) |
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| Primary | Percent Days Drinking | Percent days of any drinking at follow up, from Time Line Follow Back | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | percentage of days | Month 6 (weeks 21 - 24) |
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| Primary | 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. | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | proportion of participants | Month 2 (weeks 5 - 8 post baseline) |
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| Primary | 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. | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | proportion of participants | Month 3 (weeks 9 - 12 post baseline) |
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| Primary | 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. | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | proportion of participants | Month 4 (weeks 13 - 16 post baseline) |
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| Primary | 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. | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | proportion of participants | Month 5 (weeks 17 to 20 post baseline) |
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| Primary | 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. | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | proportion of participants | Month 6 (weeks 21 - 24 post baseline) |
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| Primary | 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 | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | percentage of days | Month 2 (weeks 5 - 8 post baseline) |
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| Primary | 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. | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | percentage of days | Month 3 (weeks 9 - 12 post baseline) |
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| Primary | 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 | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | percentage of days | Month 4 (weeks 13 - 16 post baseline) |
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| Primary | 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 | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | percentage of days | Month 5 ( weeks 17 - 20 post baseline) |
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| Primary | 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 | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | percentage of days | Month 6 (weeks 21 - 24 post baseline) |
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| Primary | Any Cocaine Use | Any cocaine using self report, binary measure of percent days cocaine use. | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | proportion of participants | Month 3 (weeks 9 - 12 post baseline) |
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| Primary | Any Cocaine Use | Any cocaine using self report, binary measure of percent days cocaine use | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | proportion of participants | Month 4 (weeks 13 - 16 post baseline) |
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| Primary | Any Cocaine Use | Any cocaine using self report, binary measure of percent days cocaine use | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | proportion of participants | Month 5 (weeks 17 - 20 post baseline) |
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| Primary | Any Cocaine Use | Any cocaine using self report, binary measure of percent days cocaine use | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | proportion of participants | Month 6 (weeks 21 - 24 post baseline) |
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| Primary | Percent Days Cocaine Use | Percent days of any cocaine use, self reported | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | percentage of days | Month 3 (weeks 9 - 12 post baseline) |
|
|
|
| Primary | Percent Days Cocaine Use | Percent days of any cocaine use, self reported | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | percentage of days | Month 5 (weeks 17 - 20 post baseline) |
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|
|
| Primary | Percent Days Cocaine Use | Percent days of any cocaine use, self reported | The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses. | Posted | Mean | Standard Deviation | percentage of days | Month 6 (weeks 21 - 24 post baseline) |
|
|
|
|
| 0 |
| 227 |
| 34 |
| 227 |
| 0 |
| 227 |
| EG001 | MI-PC Non-engaged at 2 Weeks | Participants start at IOP, but at 2 weeks are non-engaged. Randomized to treatment choice: Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. Telephone counseling: one telephone counseling session per week for 10 weeks. Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks. Medication Management: Prescription for naltrexone Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day. | 0 | 93 | 16 | 93 | 0 | 93 |
| EG002 | MI-IOP Non-Engaged at 2 Weeks | Participants start at IOP, but at 2 weeks are non-engaged. Randomized to IOP Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. | 0 | 96 | 9 | 96 | 0 | 96 |
| EG003 | MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks | Participants start at IOP, Engaged at 2 weeks but disengage between 3 - 8 weeks. Randomized to treatment choice: Motivational Interviewing: 2 sessions at week 2 Telephone counseling: one telephone counseling session per week for 10 weeks. Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks. Medication Management: Prescription for naltrexone Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day. | 1 | 41 | 4 | 41 | 0 | 41 |
| EG004 | MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks | Initially engaged at IOP, but become non-engaged in weeks 3 - 8. Randomized to IOP Motivational Interviewing: 2 sessions at week 2 | 0 | 43 | 4 | 43 | 0 | 43 |
|
Not provided
Not provided
| D005159 | Health Care Facilities Workforce and Services |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D003153 | Community Health Services |
| D010593 | Pharmaceutical Services |
| D054524 | Medicare Part D |
| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| Chi-squared |
| 0.16 |
| Odds Ratio (OR) |
| 0.54 |
| 2-Sided |
| 95 |
| 0.23 |
| 1.27 |
| Other |
| The statistical analyses used data from all follow up assessments. | Chi-squared | 0.79 | Odds Ratio (OR) | 1.12 | 2-Sided | 95 | 0.48 | 2.60 | Other |
| Chi-squared |
| 0.23 |
| Odds Ratio (OR) |
| -0.84 |
| 2-Sided |
| 95 |
| -2.20 |
| 0.52 |
| Other |
| The statistical analyses used data from all follow up assessments. | Chi-squared | 0.58 | Odds Ratio (OR) | -0.34 | 2-Sided | 95 | -1.52 | 0.85 | Other |
| Chi-squared |
| 0.36 |
| Odds Ratio (OR) |
| 0.67 |
| 2-Sided |
| 95 |
| 0.29 |
| 1.54 |
| Other |
| The statistical analyses used data from all follow up assessments. | Chi-squared | 0.45 | Odds Ratio (OR) | 1.43 | 2-Sided | 95 | 0.58 | 3.54 | Other |
| Chi-squared |
| 0.10 |
| Odds Ratio (OR) |
| 0.02 |
| 2-Sided |
| 95 |
| -1.10 |
| 1.14 |
| Other |
| Chi-squared |
| 0.71 |
| Odds Ratio (OR) |
| 0.83 |
| 2-Sided |
| 95 |
| 0.33 |
| 2.12 |
| Other |
| The statistical analyses used data from all follow up assessments. | Chi-squared | 0.36 | Odds Ratio (OR) | 1.48 | 2-Sided | 95 | 0.64 | 3.40 | Other |
| Chi-squared |
| 0.16 |
| Odds Ratio (OR) |
| -0.84 |
| 2-Sided |
| 95 |
| -1.98 |
| 0.30 |
| Other |
| The statistical analyses used data from all follow up assessments. | Chi-squared | 0.42 | Odds Ratio (OR) | 0.60 | 2-Sided | 95 | -0.85 | 2.04 | Other |