Trial Outcomes & Findings for Adaptive Treatment for Alcohol and Cocaine Dependence (NCT NCT01032135)

NCT ID: NCT01032135

Last Updated: 2017-09-05

Results Overview

Number of treatment sessions attended

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 500 participants
• Primary outcome timeframe: weeks 3 - 12
• Results posted on: 2017-09-05

Participant Flow

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.

Participant milestones

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	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.	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.	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	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	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	No Further Intervention Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
2 Week Randomization STARTED	311	93	96	0	0	0	0
2 Week Randomization COMPLETED	311	93	96	0	0	0	0
2 Week Randomization NOT COMPLETED	0	0	0	0	0	0	0
8 Week Randomization STARTED	227	0	0	41	43	48	54
8 Week Randomization 12 Week Follow up	217	0	0	34	38	36	41
8 Week Randomization COMPLETED	201	0	0	30	34	31	36
8 Week Randomization NOT COMPLETED	26	0	0	11	9	17	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adaptive Treatment for Alcohol and Cocaine Dependence

Baseline characteristics by cohort

Measure	Engaged n=227 Participants 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.	MI-PC Non-Engaged n=93 Participants 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.	MI-IOP Non-Engaged n=96 Participants 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.	MI-PC Engaged at 2 Weeks, Non-engaged Before 8 Weeks n=41 Participants 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.	MI-IOP Engaged at 2 Weeks, Non-engaged Before 8 Weeks n=43 Participants 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.	Total n=500 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	224 Participants n=5 Participants	91 Participants n=7 Participants	94 Participants n=5 Participants	41 Participants n=4 Participants	43 Participants n=21 Participants	493 Participants n=8 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	7 Participants n=8 Participants
Age, Continuous	49.4 years STANDARD_DEVIATION 8.35 • n=5 Participants	48.02 years STANDARD_DEVIATION 9.84 • n=7 Participants	47.7 years STANDARD_DEVIATION 9.38 • n=5 Participants	47.8 years STANDARD_DEVIATION 9.42 • n=4 Participants	48.5 years STANDARD_DEVIATION 9.64 • n=21 Participants	48.29 years STANDARD_DEVIATION 8.92 • n=8 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	21 Participants n=7 Participants	21 Participants n=5 Participants	8 Participants n=4 Participants	9 Participants n=21 Participants	95 Participants n=8 Participants
Sex: Female, Male Male	191 Participants n=5 Participants	72 Participants n=7 Participants	75 Participants n=5 Participants	33 Participants n=4 Participants	34 Participants n=21 Participants	405 Participants n=8 Participants
Region of Enrollment United States	227 participants n=5 Participants	93 participants n=7 Participants	96 participants n=5 Participants	41 participants n=4 Participants	43 participants n=21 Participants	500 participants n=8 Participants

PRIMARY outcome

Timeframe: weeks 3 - 12

Number of treatment sessions attended

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=93 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=96 Participants 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.	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	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	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	No Further Intervention Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Treatment Engagement	—	3.92 treatment days Standard Deviation 3.27	3.50 treatment days Standard Deviation 3.23	—	—	—	—

PRIMARY outcome

Timeframe: weeks 9 - 12

Number of treatment sessions attended

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	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.	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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=34 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=38 Participants 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	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	No Further Intervention Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks	—	—	—	1.28 treatment days Standard Deviation 1.55	0.76 treatment days Standard Deviation 1.25	—	—

PRIMARY outcome

Timeframe: weeks 9 - 12

Number of treatment sessions attended

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	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.	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.	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	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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=36 Participants 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	No Further Intervention n=41 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks	—	—	—	—	—	0.58 treatment days Standard Deviation 1.11	0.30 treatment days Standard Deviation 0.76

PRIMARY outcome

Timeframe: Month 2 (weeks 5 - 8 post baseline)

Population: 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.

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.

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=70 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=63 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=28 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=37 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=30 Participants 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	No Further Intervention n=32 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Any Drinking Days in Previous Month	—	0.57 proportion of participants Standard Deviation 0.50	0.37 proportion of participants Standard Deviation 0.49	0.46 proportion of participants Standard Deviation 0.51	0.41 proportion of participants Standard Deviation 0.50	0.60 proportion of participants Standard Deviation 0.50	0.63 proportion of participants Standard Deviation 0.49

PRIMARY outcome

Timeframe: Month 3 (weeks 9 - 12 post baseline)

Population: 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.

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.

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=72 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=62 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=28 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=36 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=29 Participants 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	No Further Intervention n=34 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Any Drinking Days in Previous Month	—	0.58 proportion of participants Standard Deviation 0.50	0.37 proportion of participants Standard Deviation 0.49	0.57 proportion of participants Standard Deviation 0.50	0.42 proportion of participants Standard Deviation 0.50	0.72 proportion of participants Standard Deviation 0.45	0.50 proportion of participants Standard Deviation 0.51

PRIMARY outcome

Timeframe: Month 4 (weeks 13 - 15 post baseline)

Population: 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.

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.

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=63 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=54 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=24 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=33 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=24 Participants 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	No Further Intervention n=30 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Any Drinking	—	0.49 proportion of participants Standard Deviation 0.50	0.26 proportion of participants Standard Deviation 0.44	0.42 proportion of participants Standard Deviation 0.50	0.30 proportion of participants Standard Deviation 0.47	0.50 proportion of participants Standard Deviation 0.51	0.47 proportion of participants Standard Deviation 0.51

PRIMARY outcome

Timeframe: Month 5 (weeks 16 - 20 post baseline)

Population: 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.

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.

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=63 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=54 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=24 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=33 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=24 Participants 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	No Further Intervention n=30 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Any Drinking	—	0.51 proportion of participants Standard Deviation 0.50	0.31 proportion of participants Standard Deviation 0.47	0.42 proportion of participants Standard Deviation 0.50	0.30 proportion of participants Standard Deviation 0.47	0.42 proportion of participants Standard Deviation 0.50	0.57 proportion of participants Standard Deviation 0.50

PRIMARY outcome

Timeframe: Month 6 (weeks 21 - 24 post baseline)

Population: 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.

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.

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=63 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=54 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=24 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=33 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=24 Participants 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	No Further Intervention n=30 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Any Drinking	—	0.56 proportion of participants Standard Deviation 0.50	0.31 proportion of participants Standard Deviation 0.47	0.50 proportion of participants Standard Deviation 0.51	0.27 proportion of participants Standard Deviation 0.45	0.42 proportion of participants Standard Deviation 0.50	0.63 proportion of participants Standard Deviation 0.49

PRIMARY outcome

Timeframe: Month 2 (weeks 5 - 8 post baseline)

Population: 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.

Percent days of any drinking at follow up, from Time Line Follow Back

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=70 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=63 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=28 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=37 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=30 Participants 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	No Further Intervention n=32 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Percent Days Drinking	—	12.81 percentage of days Standard Deviation 18.10	12.93 percentage of days Standard Deviation 26.81	17.35 percentage of days Standard Deviation 29.12	8.11 percentage of days Standard Deviation 15.12	20.00 percentage of days Standard Deviation 28.15	17.30 percentage of days Standard Deviation 25.80

PRIMARY outcome

Timeframe: Month 3 (weeks 9 - 12 post baseline)

Population: 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.

Percent days of any drinking at follow up, from Time Line Follow Back

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=72 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=62 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=28 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=36 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=29 Participants 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	No Further Intervention n=34 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Percent Days Drinking	—	14.51 percentage of days Standard Deviation 26.89	9.10 percentage of days Standard Deviation 21.68	15.31 percentage of days Standard Deviation 25.49	8.23 percentage of days Standard Deviation 15.24	20.02 percentage of days Standard Deviation 29.61	11.66 percentage of days Standard Deviation 23.50

PRIMARY outcome

Timeframe: Month 4 (weeks 13 - 16 post baseline)

Population: 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.

Percent days of any drinking at follow up, from Time Line Follow Back

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=63 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=53 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=24 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=33 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=23 Participants 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	No Further Intervention n=30 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Percent Days Drinking	—	15.76 percentage of days Standard Deviation 26.16	8.96 percentage of days Standard Deviation 24.65	21.13 percentage of days Standard Deviation 37.69	13.42 percentage of days Standard Deviation 29.38	6.37 percentage of days Standard Deviation 11.55	18.81 percentage of days Standard Deviation 31.37

PRIMARY outcome

Timeframe: Month 5 (weeks 17 - 20 post baseline)

Population: 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.

Percent days of any drinking at follow up, fromTime Line Follow Back

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=63 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=53 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=24 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=33 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=23 Participants 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	No Further Intervention n=30 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Percent Days Drinking	—	18.37 percentage of days Standard Deviation 29.86	8.22 percentage of days Standard Deviation 19.78	20.24 percentage of days Standard Deviation 33.31	11.47 percentage of days Standard Deviation 28.57	6.99 percentage of days Standard Deviation 15.09	20.60 percentage of days Standard Deviation 27.90

PRIMARY outcome

Timeframe: Month 6 (weeks 21 - 24)

Population: 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.

Percent days of any drinking at follow up, from Time Line Follow Back

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=63 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=53 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=24 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=33 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=23 Participants 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	No Further Intervention n=30 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Percent Days Drinking	—	14.75 percentage of days Standard Deviation 26.05	5.66 percentage of days Standard Deviation 16.61	19.05 percentage of days Standard Deviation 34.19	8.77 percentage of days Standard Deviation 24.42	8.70 percentage of days Standard Deviation 21.67	15.38 percentage of days Standard Deviation 23.06

PRIMARY outcome

Timeframe: Month 2 (weeks 5 - 8 post baseline)

Population: 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.

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.

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=70 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=63 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=28 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=37 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=30 Participants 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	No Further Intervention n=32 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Any Heavy Drinking Days	—	0.49 proportion of participants Standard Deviation 0.50	0.24 proportion of participants Standard Deviation 0.43	0.36 proportion of participants Standard Deviation 0.49	0.24 proportion of participants Standard Deviation 0.43	0.47 proportion of participants Standard Deviation 0.51	0.34 proportion of participants Standard Deviation 0.48

PRIMARY outcome

Timeframe: Month 3 (weeks 9 - 12 post baseline)

Population: 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.

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.

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=72 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=62 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=28 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=36 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=29 Participants 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	No Further Intervention n=34 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Any Heavy Drinking Days	—	0.44 proportion of participants Standard Deviation 0.50	0.26 proportion of participants Standard Deviation 0.44	0.36 proportion of participants Standard Deviation 0.49	0.33 proportion of participants Standard Deviation 0.48	0.55 proportion of participants Standard Deviation 0.51	0.32 proportion of participants Standard Deviation 0.47

PRIMARY outcome

Timeframe: Month 4 (weeks 13 - 16 post baseline)

Population: 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.

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.

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=63 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=54 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=24 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=33 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=24 Participants 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	No Further Intervention n=30 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Any Heavy Drinking Days	—	0.37 proportion of participants Standard Deviation 0.49	0.15 proportion of participants Standard Deviation 0.36	0.38 proportion of participants Standard Deviation 0.49	0.24 proportion of participants Standard Deviation 0.44	0.38 proportion of participants Standard Deviation 0.49	0.27 proportion of participants Standard Deviation 0.45

PRIMARY outcome

Timeframe: Month 5 (weeks 17 to 20 post baseline)

Population: 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.

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.

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=63 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=54 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=24 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=33 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=24 Participants 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	No Further Intervention n=30 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Any Heavy Drinking Days	—	0.37 proportion of participants Standard Deviation 0.49	0.19 proportion of participants Standard Deviation 0.39	0.38 proportion of participants Standard Deviation 0.49	0.24 proportion of participants Standard Deviation 0.44	0.25 proportion of participants Standard Deviation 0.44	0.33 proportion of participants Standard Deviation 0.48

PRIMARY outcome

Timeframe: Month 6 (weeks 21 - 24 post baseline)

Population: 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.

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.

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=63 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=54 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=24 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=33 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=24 Participants 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	No Further Intervention n=30 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Any Heavy Drinking Days	—	0.43 proportion of participants Standard Deviation 0.50	0.17 proportion of participants Standard Deviation 0.38	0.38 proportion of participants Standard Deviation 0.49	0.21 proportion of participants Standard Deviation 0.42	0.25 proportion of participants Standard Deviation 0.44	0.37 proportion of participants Standard Deviation 0.49

PRIMARY outcome

Timeframe: Month 2 (weeks 5 - 8 post baseline)

Population: 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.

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

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=70 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=63 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=28 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=37 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=30 Participants 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	No Further Intervention n=32 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Percent Days Heavy Drinking	—	11.73 percentage of days Standard Deviation 18.28	7.14 percentage of days Standard Deviation 20.11	10.59 percentage of days Standard Deviation 22.13	6.37 percentage of days Standard Deviation 14.85	12.98 percentage of days Standard Deviation 22.48	10.49 percentage of days Standard Deviation 21.16

PRIMARY outcome

Timeframe: Month 3 (weeks 9 - 12 post baseline)

Population: 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.

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.

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=72 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=62 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=28 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=36 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=29 Participants 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	No Further Intervention n=34 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Percent Days Heavy Drinking	—	10.58 percentage of days Standard Deviation 22.61	6.05 percentage of days Standard Deviation 17.92	12.37 percentage of days Standard Deviation 24.33	5.65 percentage of days Standard Deviation 14.09	14.16 percentage of days Standard Deviation 24.53	3.99 percentage of days Standard Deviation 9.04

PRIMARY outcome

Timeframe: Month 4 (weeks 13 - 16 post baseline)

Population: 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.

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

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=63 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=53 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=24 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=33 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=23 Participants 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	No Further Intervention n=30 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Percent Days Heavy Drinking	—	11.56 percentage of days Standard Deviation 23.55	7.01 percentage of days Standard Deviation 23.15	20.98 percentage of days Standard Deviation 37.77	8.98 percentage of days Standard Deviation 24.84	5.75 percentage of days Standard Deviation 11.73	13.93 percentage of days Standard Deviation 30.18

PRIMARY outcome

Timeframe: Month 5 ( weeks 17 - 20 post baseline)

Population: 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.

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

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=63 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=53 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=24 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=33 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=23 Participants 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	No Further Intervention n=30 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Percent Days Heavy Drinking	—	13.49 percentage of days Standard Deviation 27.37	5.73 percentage of days Standard Deviation 18.48	20.09 percentage of days Standard Deviation 33.40	8.33 percentage of days Standard Deviation 24.48	5.43 percentage of days Standard Deviation 15.19	15.12 percentage of days Standard Deviation 28.18

PRIMARY outcome

Timeframe: Month 6 (weeks 21 - 24 post baseline)

Population: 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.

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

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=63 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=53 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=24 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=33 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=23 Participants 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	No Further Intervention n=30 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Percent Days Heavy Drinking	—	11.30 percentage of days Standard Deviation 23.91	3.77 percentage of days Standard Deviation 15.34	18.3 percentage of days Standard Deviation 34.52	5.74 percentage of days Standard Deviation 19.25	7.61 percentage of days Standard Deviation 21.73	10.87 percentage of days Standard Deviation 22.86

PRIMARY outcome

Timeframe: Month 3 (weeks 9 - 12 post baseline)

Population: 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.

Any cocaine using self report, binary measure of percent days cocaine use.

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=83 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=76 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=26 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=33 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=29 Participants 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	No Further Intervention n=35 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Any Cocaine Use	—	0.45 proportion of participants Standard Deviation 0.50	0.42 proportion of participants Standard Deviation 0.50	0.31 proportion of participants Standard Deviation 0.47	0.36 proportion of participants Standard Deviation 0.49	0.66 proportion of participants Standard Deviation 0.48	0.46 proportion of participants Standard Deviation 0.51

PRIMARY outcome

Timeframe: Month 4 (weeks 13 - 16 post baseline)

Population: 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.

Any cocaine using self report, binary measure of percent days cocaine use

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=65 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=51 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=23 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=30 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=24 Participants 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	No Further Intervention n=31 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Any Cocaine Use	—	0.43 proportion of participants Standard Deviation 0.50	0.29 proportion of participants Standard Deviation 0.46	0.39 proportion of participants Standard Deviation 0.50	0.23 proportion of participants Standard Deviation 0.43	0.63 proportion of participants Standard Deviation 0.49	0.45 proportion of participants Standard Deviation 0.51

PRIMARY outcome

Timeframe: Month 5 (weeks 17 - 20 post baseline)

Population: 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.

Any cocaine using self report, binary measure of percent days cocaine use

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=65 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=52 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=23 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=30 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=24 Participants 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	No Further Intervention n=31 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Any Cocaine Use	—	0.45 proportion of participants Standard Deviation 0.50	0.35 proportion of participants Standard Deviation 0.48	0.35 proportion of participants Standard Deviation 0.49	0.23 proportion of participants Standard Deviation 0.43	0.58 proportion of participants Standard Deviation 0.50	0.42 proportion of participants Standard Deviation 0.50

PRIMARY outcome

Timeframe: Month 6 (weeks 21 - 24 post baseline)

Population: 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.

Any cocaine using self report, binary measure of percent days cocaine use

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=52 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=65 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=23 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=30 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=24 Participants 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	No Further Intervention n=31 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Any Cocaine Use	—	0.35 proportion of participants Standard Deviation 0.48	0.49 proportion of participants Standard Deviation 0.50	0.35 proportion of participants Standard Deviation 0.49	0.30 proportion of participants Standard Deviation 0.47	0.54 proportion of participants Standard Deviation 0.51	0.58 proportion of participants Standard Deviation 0.50

PRIMARY outcome

Timeframe: Month 3 (weeks 9 - 12 post baseline)

Population: 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.

Percent days of any cocaine use, self reported

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=74 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=60 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=26 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=33 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=30 Participants 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	No Further Intervention n=35 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Percent Days Cocaine Use	—	12.61 percentage of days Standard Deviation 25.38	9.35 percentage of days Standard Deviation 20.19	11.68 percentage of days Standard Deviation 25.33	3.90 percentage of days Standard Deviation 7.54	18.45 percentage of days Standard Deviation 28.68	12.35 percentage of days Standard Deviation 23.39

PRIMARY outcome

Timeframe: Month 5 (weeks 17 - 20 post baseline)

Population: 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.

Percent days of any cocaine use, self reported

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=68 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=53 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=23 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=31 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=25 Participants 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	No Further Intervention n=33 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Percent Days Cocaine Use	—	10.87 percentage of days Standard Deviation 23.78	12.60 percentage of days Standard Deviation 28.40	14.60 percentage of days Standard Deviation 27.00	4.26 percentage of days Standard Deviation 17.99	19.14 percentage of days Standard Deviation 33.07	15.26 percentage of days Standard Deviation 28.28

PRIMARY outcome

Timeframe: Month 6 (weeks 21 - 24 post baseline)

Population: 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.

Percent days of any cocaine use, self reported

Outcome measures

Measure	Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=68 Participants 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.	MI-IOP Non-Engaged at 2 Weeks n=53 Participants 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=23 Participants 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	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=31 Participants 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	MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks n=25 Participants 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	No Further Intervention n=33 Participants Not engaged at week 2 and still not engaged at week 8. Randomized to receive no further study intervention.
Percent Days Cocaine Use	—	7.76 percentage of days Standard Deviation 16.00	9.50 percentage of days Standard Deviation 24.27	10.09 percentage of days Standard Deviation 22.40	4.95 percentage of days Standard Deviation 13.19	15.57 percentage of days Standard Deviation 28.02	13.35 percentage of days Standard Deviation 26.10

Adverse Events

Engaged

Serious events: 34 serious events

Other events: 0 other events

Deaths: 0 deaths

MI-PC Non-engaged at 2 Weeks

Serious events: 16 serious events

Other events: 0 other events

Deaths: 0 deaths

MI-IOP Non-Engaged at 2 Weeks

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks

Serious events: 4 serious events

Other events: 0 other events

Deaths: 1 deaths

MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Engaged n=227 participants at risk Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.	MI-PC Non-engaged at 2 Weeks n=93 participants at risk 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.	MI-IOP Non-Engaged at 2 Weeks n=96 participants at risk 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.	MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks n=41 participants at risk 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.	MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks n=43 participants at risk Initially engaged at IOP, but become non-engaged in weeks 3 - 8. Randomized to IOP Motivational Interviewing: 2 sessions at week 2
General disorders Hospitalizations	15.0% 34/227 • 24 weeks	17.2% 16/93 • 24 weeks	9.4% 9/96 • 24 weeks	9.8% 4/41 • 24 weeks	9.3% 4/43 • 24 weeks

Other adverse events

Adverse event data not reported

Additional Information

James McKay, PhD

University of Pennsylvania

Phone: 215-746-7704

Email: jimrache@mail.med.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place