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Adaptive Treatment for Alcohol and Cocaine Dependence

Adaptive Treatment for Alcohol and Cocaine Dependence

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01032135
Enrollment
500
Registered
2009-12-15
Start date
2008-10-31
Completion date
2013-12-31
Last updated
2017-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorders

Brief summary

1. Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the full study sample with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use over weeks 1-24. * Hypothesis 1: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce higher rates of treatment engagement than an intervention focused on engagement in IOP only (e.g., MI-IOP). * Hypothesis 2: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce better cocaine/alcohol use outcomes than an intervention focused on engagement in IOP only (MI-IOP). * Secondary analysis 1: Among the Non-engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine/alcohol use outcomes in each option. * Secondary analysis 2: Among the Engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine/alcohol use outcomes in each option. 2. Primary objective #2: Determine whether the relative effectiveness of MI-IOP and MI-PC varies as a function of engagement group, with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use outcomes over weeks 1-24. * Hypothesis 1: The predicted main effect on retention favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group. * Hypothesis 2: The predicted main effect on cocaine/alcohol use outcomes favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.

Detailed description

3\. Secondary objective #1: Examine outcomes on three secondary measures: percent days abstinent from all substances, negative consequences of drug use, and HIV high risk behaviors. * Hypothesis 1: Outcomes on the secondary measures will be better in MI-PC than in MI-IOP. 4\. Secondary objective #2: Test hypotheses concerning potential mediators of the predicted main effect favoring MI-PC over MI-IOP. * Hypothesis 1: The predicted advantage of MI-PC over MI-IOP will be mediated by greater increases in motivation, self-efficacy, commitment to abstinence, and self-help involvement in MI-PC. 5\. Secondary objective #3: Test hypotheses concerning effect of additional MI intervention after initial non-engagement persists through 12 weeks. * Hypothesis 1: A second telephone MI intervention will produce higher rates of subsequent engagement and less cocaine use than no further MI.

Interventions

BEHAVIORALMotivational Interviewing

2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.

BEHAVIORALTelephone counseling

one telephone counseling session per week for 10 weeks.

BEHAVIORALCognitive Behavioral Therapy (CBT) Counseling

One CBT session per week, for 10 weeks.

Prescription for naltrexone

BEHAVIORALIntensive OutPatient Therapy

Return to IOP, group therapy 3 times weekly for about three hours a day.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. meet DSM-IV criteria for lifetime cocaine or alcohol dependence and have used cocaine or alcohol in the prior 6 months; 2. be \> 18 years of age; 3. be judged clinically appropriate for IOP (e.g., no current psychotic disorder or evidence of severe dementia, and no acute medical problem requiring inpatient treatment; 4. have no regular IV heroin use during the past year; 5. have access to a telephone; 6. be willing to be randomized and participate in research; and 7. no current participation in methadone or other forms of DA treatment, other than IOP. Finally, because of study follow-up requirements, subjects will 8. be required to be metropolitan area residents, and 9. be able to provide the name, verified telephone number, and address of at least two contacts who can provide locator information on the patient during follow-up. We will include patients with dependence on other substances, provided that they are cocaine dependent and meet other inclusion criteria.

Exclusion criteria

1. have a current psychotic disorder (as assessed with the psychotic screen from the MINI) or evidence of dementia severe enough to prevent participation in outpatient treatment; 2. have acute medical problem requiring immediate inpatient treatment; or 3. are currently participating in methadone or other forms of DA treatment, other than IOP.

Design outcomes

Primary

MeasureTime frameDescription
Treatment Engagementweeks 3 - 12Number of treatment sessions attended
Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeksweeks 9 - 12Number of treatment sessions attended
Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeksweeks 9 - 12Number of treatment sessions attended
Any Drinking Days in Previous MonthMonth 2 (weeks 5 - 8 post baseline)Days of any drinking in previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Any DrinkingMonth 4 (weeks 13 - 15 post baseline)Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Percent Days DrinkingMonth 2 (weeks 5 - 8 post baseline)Percent days of any drinking at follow up, from Time Line Follow Back
Any Heavy Drinking DaysMonth 2 (weeks 5 - 8 post baseline)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.
Percent Days Heavy DrinkingMonth 2 (weeks 5 - 8 post baseline)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
Any Cocaine UseMonth 3 (weeks 9 - 12 post baseline)Any cocaine using self report, binary measure of percent days cocaine use.
Percent Days Cocaine UseMonth 3 (weeks 9 - 12 post baseline)Percent days of any cocaine use, self reported

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
Engaged
Participants began treatment in IOP, consistently remained engaged in IOP throughout the study time period. This group did not reach the threshold of needing study intervention.
227
MI-PC Non-Engaged
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.
93
MI-IOP Non-Engaged
Participants began treatment in IOP but were not engaged at week 2. Randomized back to IOP. Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
96
MI-PC Engaged at 2 Weeks, Non-engaged Before 8 Weeks
Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized to Patient Choice. Motivational Interviewing: 2 sessions at week 2. Telephone counseling: one telephone counseling session per week for 10 weeks. Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks. medication management: Prescription for naltrexone Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.
41
MI-IOP Engaged at 2 Weeks, Non-engaged Before 8 Weeks
Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized back to IOP. Motivational Interviewing: 2 sessions at week 2.
43
Total500

Baseline characteristics

CharacteristicMI-PC Non-EngagedMI-IOP Non-EngagedMI-PC Engaged at 2 Weeks, Non-engaged Before 8 WeeksEngagedMI-IOP Engaged at 2 Weeks, Non-engaged Before 8 WeeksTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants2 Participants0 Participants3 Participants0 Participants7 Participants
Age, Categorical
Between 18 and 65 years
91 Participants94 Participants41 Participants224 Participants43 Participants493 Participants
Age, Continuous48.02 years
STANDARD_DEVIATION 9.84
47.7 years
STANDARD_DEVIATION 9.38
47.8 years
STANDARD_DEVIATION 9.42
49.4 years
STANDARD_DEVIATION 8.35
48.5 years
STANDARD_DEVIATION 9.64
48.29 years
STANDARD_DEVIATION 8.92
Region of Enrollment
United States
93 participants96 participants41 participants227 participants43 participants500 participants
Sex: Female, Male
Female
21 Participants21 Participants8 Participants36 Participants9 Participants95 Participants
Sex: Female, Male
Male
72 Participants75 Participants33 Participants191 Participants34 Participants405 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 2270 / 930 / 961 / 410 / 43
other
Total, other adverse events
0 / 2270 / 930 / 960 / 410 / 43
serious
Total, serious adverse events
34 / 22716 / 939 / 964 / 414 / 43

Outcome results

Primary

Any Cocaine Use

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

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksAny Cocaine Use0.43 proportion of participantsStandard Deviation 0.5
MI-IOP Non-Engaged at 2 WeeksAny Cocaine Use0.29 proportion of participantsStandard Deviation 0.46
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksAny Cocaine Use0.39 proportion of participantsStandard Deviation 0.5
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksAny Cocaine Use0.23 proportion of participantsStandard Deviation 0.43
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksAny Cocaine Use0.63 proportion of participantsStandard Deviation 0.49
No Further InterventionAny Cocaine Use0.45 proportion of participantsStandard Deviation 0.51
Primary

Any Cocaine Use

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

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksAny Cocaine Use0.35 proportion of participantsStandard Deviation 0.48
MI-IOP Non-Engaged at 2 WeeksAny Cocaine Use0.49 proportion of participantsStandard Deviation 0.5
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksAny Cocaine Use0.35 proportion of participantsStandard Deviation 0.49
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksAny Cocaine Use0.30 proportion of participantsStandard Deviation 0.47
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksAny Cocaine Use0.54 proportion of participantsStandard Deviation 0.51
No Further InterventionAny Cocaine Use0.58 proportion of participantsStandard Deviation 0.5
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.1395% CI: [0.38, 1.14]Chi-squared
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.7195% CI: [0.33, 2.12]Chi-squared
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.3695% CI: [0.64, 3.4]Chi-squared
Primary

Any Cocaine Use

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

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksAny Cocaine Use0.45 proportion of participantsStandard Deviation 0.5
MI-IOP Non-Engaged at 2 WeeksAny Cocaine Use0.35 proportion of participantsStandard Deviation 0.48
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksAny Cocaine Use0.35 proportion of participantsStandard Deviation 0.49
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksAny Cocaine Use0.23 proportion of participantsStandard Deviation 0.43
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksAny Cocaine Use0.58 proportion of participantsStandard Deviation 0.5
No Further InterventionAny Cocaine Use0.42 proportion of participantsStandard Deviation 0.5
Primary

Any Cocaine Use

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

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksAny Cocaine Use0.45 proportion of participantsStandard Deviation 0.5
MI-IOP Non-Engaged at 2 WeeksAny Cocaine Use0.42 proportion of participantsStandard Deviation 0.5
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksAny Cocaine Use0.31 proportion of participantsStandard Deviation 0.47
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksAny Cocaine Use0.36 proportion of participantsStandard Deviation 0.49
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksAny Cocaine Use0.66 proportion of participantsStandard Deviation 0.48
No Further InterventionAny Cocaine Use0.46 proportion of participantsStandard Deviation 0.51
Primary

Any Drinking

Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksAny Drinking0.56 proportion of participantsStandard Deviation 0.5
MI-IOP Non-Engaged at 2 WeeksAny Drinking0.31 proportion of participantsStandard Deviation 0.47
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksAny Drinking0.50 proportion of participantsStandard Deviation 0.51
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksAny Drinking0.27 proportion of participantsStandard Deviation 0.45
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksAny Drinking0.42 proportion of participantsStandard Deviation 0.5
No Further InterventionAny Drinking0.63 proportion of participantsStandard Deviation 0.49
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.000795% CI: [0.23, 0.68]Chi-squared
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.1695% CI: [0.23, 1.27]Chi-squared
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.7995% CI: [0.48, 2.6]Chi-squared
Primary

Any Drinking

Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksAny Drinking0.49 proportion of participantsStandard Deviation 0.5
MI-IOP Non-Engaged at 2 WeeksAny Drinking0.26 proportion of participantsStandard Deviation 0.44
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksAny Drinking0.42 proportion of participantsStandard Deviation 0.5
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksAny Drinking0.30 proportion of participantsStandard Deviation 0.47
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksAny Drinking0.50 proportion of participantsStandard Deviation 0.51
No Further InterventionAny Drinking0.47 proportion of participantsStandard Deviation 0.51
Primary

Any Drinking

Any drinking at follow up, as reported on Time Line Follow Back, This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksAny Drinking0.51 proportion of participantsStandard Deviation 0.5
MI-IOP Non-Engaged at 2 WeeksAny Drinking0.31 proportion of participantsStandard Deviation 0.47
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksAny Drinking0.42 proportion of participantsStandard Deviation 0.5
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksAny Drinking0.30 proportion of participantsStandard Deviation 0.47
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksAny Drinking0.42 proportion of participantsStandard Deviation 0.5
No Further InterventionAny Drinking0.57 proportion of participantsStandard Deviation 0.5
Primary

Any Drinking Days in Previous Month

Any drinking days during previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksAny Drinking Days in Previous Month0.58 proportion of participantsStandard Deviation 0.5
MI-IOP Non-Engaged at 2 WeeksAny Drinking Days in Previous Month0.37 proportion of participantsStandard Deviation 0.49
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksAny Drinking Days in Previous Month0.57 proportion of participantsStandard Deviation 0.5
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksAny Drinking Days in Previous Month0.42 proportion of participantsStandard Deviation 0.5
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksAny Drinking Days in Previous Month0.72 proportion of participantsStandard Deviation 0.45
No Further InterventionAny Drinking Days in Previous Month0.50 proportion of participantsStandard Deviation 0.51
Primary

Any Drinking Days in Previous Month

Days of any drinking in previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksAny Drinking Days in Previous Month0.57 proportion of participantsStandard Deviation 0.5
MI-IOP Non-Engaged at 2 WeeksAny Drinking Days in Previous Month0.37 proportion of participantsStandard Deviation 0.49
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksAny Drinking Days in Previous Month0.46 proportion of participantsStandard Deviation 0.51
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksAny Drinking Days in Previous Month0.41 proportion of participantsStandard Deviation 0.5
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksAny Drinking Days in Previous Month0.60 proportion of participantsStandard Deviation 0.5
No Further InterventionAny Drinking Days in Previous Month0.63 proportion of participantsStandard Deviation 0.49
Primary

Any Heavy Drinking Days

five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksAny Heavy Drinking Days0.44 proportion of participantsStandard Deviation 0.5
MI-IOP Non-Engaged at 2 WeeksAny Heavy Drinking Days0.26 proportion of participantsStandard Deviation 0.44
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksAny Heavy Drinking Days0.36 proportion of participantsStandard Deviation 0.49
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksAny Heavy Drinking Days0.33 proportion of participantsStandard Deviation 0.48
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksAny Heavy Drinking Days0.55 proportion of participantsStandard Deviation 0.51
No Further InterventionAny Heavy Drinking Days0.32 proportion of participantsStandard Deviation 0.47
Primary

Any Heavy Drinking Days

days of five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksAny Heavy Drinking Days0.49 proportion of participantsStandard Deviation 0.5
MI-IOP Non-Engaged at 2 WeeksAny Heavy Drinking Days0.24 proportion of participantsStandard Deviation 0.43
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksAny Heavy Drinking Days0.36 proportion of participantsStandard Deviation 0.49
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksAny Heavy Drinking Days0.24 proportion of participantsStandard Deviation 0.43
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksAny Heavy Drinking Days0.47 proportion of participantsStandard Deviation 0.51
No Further InterventionAny Heavy Drinking Days0.34 proportion of participantsStandard Deviation 0.48
Primary

Any Heavy Drinking Days

five or more drinks per drinking day for men, four or more drinks per drinking day for women at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksAny Heavy Drinking Days0.37 proportion of participantsStandard Deviation 0.49
MI-IOP Non-Engaged at 2 WeeksAny Heavy Drinking Days0.15 proportion of participantsStandard Deviation 0.36
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksAny Heavy Drinking Days0.38 proportion of participantsStandard Deviation 0.49
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksAny Heavy Drinking Days0.24 proportion of participantsStandard Deviation 0.44
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksAny Heavy Drinking Days0.38 proportion of participantsStandard Deviation 0.49
No Further InterventionAny Heavy Drinking Days0.27 proportion of participantsStandard Deviation 0.45
Primary

Any Heavy Drinking Days

five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksAny Heavy Drinking Days0.37 proportion of participantsStandard Deviation 0.49
MI-IOP Non-Engaged at 2 WeeksAny Heavy Drinking Days0.19 proportion of participantsStandard Deviation 0.39
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksAny Heavy Drinking Days0.38 proportion of participantsStandard Deviation 0.49
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksAny Heavy Drinking Days0.24 proportion of participantsStandard Deviation 0.44
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksAny Heavy Drinking Days0.25 proportion of participantsStandard Deviation 0.44
No Further InterventionAny Heavy Drinking Days0.33 proportion of participantsStandard Deviation 0.48
Primary

Any Heavy Drinking Days

five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksAny Heavy Drinking Days0.43 proportion of participantsStandard Deviation 0.5
MI-IOP Non-Engaged at 2 WeeksAny Heavy Drinking Days0.17 proportion of participantsStandard Deviation 0.38
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksAny Heavy Drinking Days0.38 proportion of participantsStandard Deviation 0.49
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksAny Heavy Drinking Days0.21 proportion of participantsStandard Deviation 0.42
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksAny Heavy Drinking Days0.25 proportion of participantsStandard Deviation 0.44
No Further InterventionAny Heavy Drinking Days0.37 proportion of participantsStandard Deviation 0.49
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.000195% CI: [0.19, 0.58]Chi-squared
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.3695% CI: [0.29, 1.54]Chi-squared
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.4595% CI: [0.58, 3.54]Chi-squared
Primary

Percent Days Cocaine Use

Percent days of any cocaine use, self reported

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksPercent Days Cocaine Use7.76 percentage of daysStandard Deviation 16
MI-IOP Non-Engaged at 2 WeeksPercent Days Cocaine Use9.50 percentage of daysStandard Deviation 24.27
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Cocaine Use10.09 percentage of daysStandard Deviation 22.4
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Cocaine Use4.95 percentage of daysStandard Deviation 13.19
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksPercent Days Cocaine Use15.57 percentage of daysStandard Deviation 28.02
No Further InterventionPercent Days Cocaine Use13.35 percentage of daysStandard Deviation 26.1
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.7595% CI: [-0.94, 0.6]Chi-squared
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.1695% CI: [-1.98, 0.3]Chi-squared
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.4295% CI: [-0.85, 2.04]Chi-squared
Primary

Percent Days Cocaine Use

Percent days of any cocaine use, self reported

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksPercent Days Cocaine Use12.61 percentage of daysStandard Deviation 25.38
MI-IOP Non-Engaged at 2 WeeksPercent Days Cocaine Use9.35 percentage of daysStandard Deviation 20.19
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Cocaine Use11.68 percentage of daysStandard Deviation 25.33
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Cocaine Use3.90 percentage of daysStandard Deviation 7.54
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksPercent Days Cocaine Use18.45 percentage of daysStandard Deviation 28.68
No Further InterventionPercent Days Cocaine Use12.35 percentage of daysStandard Deviation 23.39
Primary

Percent Days Cocaine Use

Percent days of any cocaine use, self reported

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksPercent Days Cocaine Use10.87 percentage of daysStandard Deviation 23.78
MI-IOP Non-Engaged at 2 WeeksPercent Days Cocaine Use12.60 percentage of daysStandard Deviation 28.4
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Cocaine Use14.60 percentage of daysStandard Deviation 27
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Cocaine Use4.26 percentage of daysStandard Deviation 17.99
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksPercent Days Cocaine Use19.14 percentage of daysStandard Deviation 33.07
No Further InterventionPercent Days Cocaine Use15.26 percentage of daysStandard Deviation 28.28
Primary

Percent Days Drinking

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

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksPercent Days Drinking14.75 percentage of daysStandard Deviation 26.05
MI-IOP Non-Engaged at 2 WeeksPercent Days Drinking5.66 percentage of daysStandard Deviation 16.61
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Drinking19.05 percentage of daysStandard Deviation 34.19
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Drinking8.77 percentage of daysStandard Deviation 24.42
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksPercent Days Drinking8.70 percentage of daysStandard Deviation 21.67
No Further InterventionPercent Days Drinking15.38 percentage of daysStandard Deviation 23.06
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.00995% CI: [-1.87, -0.29]Chi-squared
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.2395% CI: [-2.2, 0.52]Chi-squared
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.5895% CI: [-1.52, 0.85]Chi-squared
Primary

Percent Days Drinking

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

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksPercent Days Drinking12.81 percentage of daysStandard Deviation 18.1
MI-IOP Non-Engaged at 2 WeeksPercent Days Drinking12.93 percentage of daysStandard Deviation 26.81
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Drinking17.35 percentage of daysStandard Deviation 29.12
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Drinking8.11 percentage of daysStandard Deviation 15.12
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksPercent Days Drinking20.00 percentage of daysStandard Deviation 28.15
No Further InterventionPercent Days Drinking17.30 percentage of daysStandard Deviation 25.8
Primary

Percent Days Drinking

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

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksPercent Days Drinking14.51 percentage of daysStandard Deviation 26.89
MI-IOP Non-Engaged at 2 WeeksPercent Days Drinking9.10 percentage of daysStandard Deviation 21.68
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Drinking15.31 percentage of daysStandard Deviation 25.49
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Drinking8.23 percentage of daysStandard Deviation 15.24
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksPercent Days Drinking20.02 percentage of daysStandard Deviation 29.61
No Further InterventionPercent Days Drinking11.66 percentage of daysStandard Deviation 23.5
Primary

Percent Days Drinking

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

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksPercent Days Drinking18.37 percentage of daysStandard Deviation 29.86
MI-IOP Non-Engaged at 2 WeeksPercent Days Drinking8.22 percentage of daysStandard Deviation 19.78
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Drinking20.24 percentage of daysStandard Deviation 33.31
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Drinking11.47 percentage of daysStandard Deviation 28.57
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksPercent Days Drinking6.99 percentage of daysStandard Deviation 15.09
No Further InterventionPercent Days Drinking20.60 percentage of daysStandard Deviation 27.9
Primary

Percent Days Drinking

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

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksPercent Days Drinking15.76 percentage of daysStandard Deviation 26.16
MI-IOP Non-Engaged at 2 WeeksPercent Days Drinking8.96 percentage of daysStandard Deviation 24.65
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Drinking21.13 percentage of daysStandard Deviation 37.69
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Drinking13.42 percentage of daysStandard Deviation 29.38
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksPercent Days Drinking6.37 percentage of daysStandard Deviation 11.55
No Further InterventionPercent Days Drinking18.81 percentage of daysStandard Deviation 31.37
Primary

Percent Days Heavy Drinking

Percent days heavy drinking at follow up, from Time Line Follow Back \* heavy drinking is defined as five or more drinks per drinking day for men, four or more for women

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksPercent Days Heavy Drinking13.49 percentage of daysStandard Deviation 27.37
MI-IOP Non-Engaged at 2 WeeksPercent Days Heavy Drinking5.73 percentage of daysStandard Deviation 18.48
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Heavy Drinking20.09 percentage of daysStandard Deviation 33.4
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Heavy Drinking8.33 percentage of daysStandard Deviation 24.48
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksPercent Days Heavy Drinking5.43 percentage of daysStandard Deviation 15.19
No Further InterventionPercent Days Heavy Drinking15.12 percentage of daysStandard Deviation 28.18
Primary

Percent Days Heavy Drinking

Percent days heavy drinking at follow up, from Time Line Follow Back \*heavy drinking is defined as five or more drinks per day for men, four or more for women

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksPercent Days Heavy Drinking11.73 percentage of daysStandard Deviation 18.28
MI-IOP Non-Engaged at 2 WeeksPercent Days Heavy Drinking7.14 percentage of daysStandard Deviation 20.11
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Heavy Drinking10.59 percentage of daysStandard Deviation 22.13
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Heavy Drinking6.37 percentage of daysStandard Deviation 14.85
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksPercent Days Heavy Drinking12.98 percentage of daysStandard Deviation 22.48
No Further InterventionPercent Days Heavy Drinking10.49 percentage of daysStandard Deviation 21.16
Primary

Percent Days Heavy Drinking

Percent days heavy drinking at follow up, from Time Line Follow Back \* heavy drinking is defined as five or more drinks per day for men, four or more for women.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksPercent Days Heavy Drinking10.58 percentage of daysStandard Deviation 22.61
MI-IOP Non-Engaged at 2 WeeksPercent Days Heavy Drinking6.05 percentage of daysStandard Deviation 17.92
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Heavy Drinking12.37 percentage of daysStandard Deviation 24.33
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Heavy Drinking5.65 percentage of daysStandard Deviation 14.09
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksPercent Days Heavy Drinking14.16 percentage of daysStandard Deviation 24.53
No Further InterventionPercent Days Heavy Drinking3.99 percentage of daysStandard Deviation 9.04
Primary

Percent Days Heavy Drinking

Percent days heavy drinking at follow up, from Time Line Follow Back \*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksPercent Days Heavy Drinking11.56 percentage of daysStandard Deviation 23.55
MI-IOP Non-Engaged at 2 WeeksPercent Days Heavy Drinking7.01 percentage of daysStandard Deviation 23.15
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Heavy Drinking20.98 percentage of daysStandard Deviation 37.77
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Heavy Drinking8.98 percentage of daysStandard Deviation 24.84
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksPercent Days Heavy Drinking5.75 percentage of daysStandard Deviation 11.73
No Further InterventionPercent Days Heavy Drinking13.93 percentage of daysStandard Deviation 30.18
Primary

Percent Days Heavy Drinking

Percent days heavy drinking at follow up, from Time Line Follow Back \*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksPercent Days Heavy Drinking11.30 percentage of daysStandard Deviation 23.91
MI-IOP Non-Engaged at 2 WeeksPercent Days Heavy Drinking3.77 percentage of daysStandard Deviation 15.34
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Heavy Drinking18.3 percentage of daysStandard Deviation 34.52
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksPercent Days Heavy Drinking5.74 percentage of daysStandard Deviation 19.25
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksPercent Days Heavy Drinking7.61 percentage of daysStandard Deviation 21.73
No Further InterventionPercent Days Heavy Drinking10.87 percentage of daysStandard Deviation 22.86
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.00395% CI: [-1.8, -0.39]Chi-squared
Comparison: The statistical analyses used data from all follow up assessments.p-value: 0.195% CI: [-1.1, 1.14]Chi-squared
Primary

Treatment Engagement

Number of treatment sessions attended

Time frame: weeks 3 - 12

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 WeeksTreatment Engagement3.92 treatment daysStandard Deviation 3.27
MI-IOP Non-Engaged at 2 WeeksTreatment Engagement3.50 treatment daysStandard Deviation 3.23
p-value: 0.11Chi-squared
Primary

Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks

Number of treatment sessions attended

Time frame: weeks 9 - 12

ArmMeasureValue (MEAN)Dispersion
MI-PC Engaged at 2 Weeks, Disengage Before 8 WeeksTreatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks1.28 treatment daysStandard Deviation 1.55
MI-IOP Engaged at 2 Weeks, Disengage Before 8 WeeksTreatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks0.76 treatment daysStandard Deviation 1.25
p-value: 0.02Chi-squared
Primary

Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks

Number of treatment sessions attended

Time frame: weeks 9 - 12

ArmMeasureValue (MEAN)Dispersion
MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 WeeksTreatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks0.58 treatment daysStandard Deviation 1.11
No Further InterventionTreatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks0.30 treatment daysStandard Deviation 0.76
p-value: 0.005Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026