Trial Outcomes & Findings for Effectiveness of Extended Treatments for Drug Dependence (NCT NCT00685659)

NCT ID: NCT00685659

Last Updated: 2017-08-07

Results Overview

Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 332 participants
• Primary outcome timeframe: 3 month follow up
• Results posted on: 2017-08-07

Participant Flow

We enrolled 332, but 11 of those were pilot participants assigned to receive the Telephone Monitoring and Counseling plus vouchers. They were not randomly assigned participants and their data was not included in the final analyses.

Participant milestones

Measure	Treatment as Usual Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Overall Study STARTED	108	106	107
Overall Study COMPLETED	77	81	92
Overall Study NOT COMPLETED	31	25	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Extended Treatments for Drug Dependence

Baseline characteristics by cohort

Measure	Treatment as Usual n=108 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=106 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=107 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included	Total n=321 Participants Total of all reporting groups
Age, Continuous	42.9 years STANDARD_DEVIATION 8.0 • n=5 Participants	43.3 years STANDARD_DEVIATION 7.8 • n=7 Participants	43.4 years STANDARD_DEVIATION 6.48 • n=5 Participants	43.2 years STANDARD_DEVIATION 7.43 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	26 Participants n=7 Participants	24 Participants n=5 Participants	76 Participants n=4 Participants
Sex: Female, Male Male	82 Participants n=5 Participants	80 Participants n=7 Participants	83 Participants n=5 Participants	245 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	105 Participants n=5 Participants	99 Participants n=7 Participants	104 Participants n=5 Participants	308 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	97 Participants n=5 Participants	89 Participants n=7 Participants	98 Participants n=5 Participants	284 Participants n=4 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	24 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment United States	108 participants n=5 Participants	106 participants n=7 Participants	107 participants n=5 Participants	321 participants n=4 Participants

PRIMARY outcome

Timeframe: 3 month follow up

Population: The N analyzed represents that number of people we reached for three month follow up evaluation.

Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.

Outcome measures

Measure	Treatment as Usual n=96 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=97 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=96 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Abstinence	45 participants	57 participants	45 participants

PRIMARY outcome

Timeframe: 6 month follow up

Population: The N analyzed represents that number of participants we reached for 6 month follow up evaluation.

Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.

Outcome measures

Measure	Treatment as Usual n=95 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=95 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=95 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Abstinence	43 participants	44 participants	42 participants

PRIMARY outcome

Timeframe: 9 month follow up

Population: The N analyzed represents the number of participants we were able to reach for the 9 month follow up evaluation.

Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.

Outcome measures

Measure	Treatment as Usual n=91 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=91 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=91 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Abstinence	43 participants	44 participants	39 participants

PRIMARY outcome

Timeframe: 12 month follow up

Population: The N analyzed represents the number of participants we were able to reach at the 12 month follow up for evaluation.

Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.

Outcome measures

Measure	Treatment as Usual n=89 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=90 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=90 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Abstinence	33 participants	39 participants	42 participants

PRIMARY outcome

Timeframe: 18 month follow up

Population: The N analyzed represents the number of participants we were able to reach for the 18 month follow up.

Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.

Outcome measures

Measure	Treatment as Usual n=77 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=79 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=83 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Abstinence	30 participants	27 participants	34 participants

PRIMARY outcome

Timeframe: 24 month follow up

Population: The N analyzed represents the number of participants we were able to reach for 24 month follow up.

Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.

Outcome measures

Measure	Treatment as Usual n=59 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=64 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=68 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Abstinence	20 participants	28 participants	24 participants

PRIMARY outcome

Timeframe: 3 month follow up

Population: The N analyzed represents the number of participants for whom we had UDS results in month 3.

Positive cocaine test of urine

Outcome measures

Measure	Treatment as Usual n=89 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=76 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=83 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Cocaine Urine Toxicology	0.31 proportion of participants positive	0.22 proportion of participants positive	0.20 proportion of participants positive

PRIMARY outcome

Timeframe: 6 month follow up

Population: The N analyzed represents the number of participants for whom we had UDS results in month 6.

Positive cocaine test of urine

Outcome measures

Measure	Treatment as Usual n=82 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=76 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=83 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Cocaine Urine Toxicology	0.26 proportion of participants positive	0.24 proportion of participants positive	0.28 proportion of participants positive

PRIMARY outcome

Timeframe: 9 month follow up

Population: The N analyzed represents the number of participants for whom we had UDS results in month 9.

Positive cocaine test of urine

Outcome measures

Measure	Treatment as Usual n=74 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=69 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=78 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Cocaine Urine Toxicology	0.30 proportion of participants positive	0.25 proportion of participants positive	0.29 proportion of participants positive

PRIMARY outcome

Timeframe: 12 month follow up

Population: The N analyzed represents the number of participants for whom we had UDS results in month 12.

Positive cocaine test of urine

Outcome measures

Measure	Treatment as Usual n=76 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=73 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=77 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Cocaine Urine Toxicology	0.37 proportion of participants positive	0.27 proportion of participants positive	0.27 proportion of participants positive

PRIMARY outcome

Timeframe: 18 month follow up

Population: The N analyzed represents the number of participants for whom we had UDS results in month 18.

Positive cocaine test of urine

Outcome measures

Measure	Treatment as Usual n=67 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=72 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=80 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Cocaine Urine Toxicology	0.33 proportion of participants positive	0.29 proportion of participants positive	0.24 proportion of participants positive

PRIMARY outcome

Timeframe: 24 month follow up

Population: The N analyzed represents the number of participants for whom we had UDS results in month 24.

Positive cocaine test of urine

Outcome measures

Measure	Treatment as Usual n=69 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=80 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=75 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Cocaine Urine Toxicology	038 proportion of participants positive	0.26 proportion of participants positive	0.35 proportion of participants positive

PRIMARY outcome

Timeframe: 24 months

Total savings/spending calculated as the monetary value of days of illegal activity, days experiencing medical problems, days experiencing psychiatric problems, and days in jail captured with the ASI. Presented in 2008 dollars.

Outcome measures

Measure	Treatment as Usual n=108 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=106 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=107 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Comparison Across Groups in Societal Costs	-1545 US Dollars Standard Deviation 23195	1564 US Dollars Standard Deviation 10997	-191 US Dollars Standard Deviation 20514

PRIMARY outcome

Timeframe: 24 months

Savings minus intervention costs. Presented in 2008 dollars.

Outcome measures

Measure	Treatment as Usual n=108 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=106 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=107 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Net Saving/Spending Comparisons Across Groups From Provider Perspective	-1545 US Dollars Standard Deviation 23195	1222 US Dollars Standard Deviation 11000	-750 US Dollars Standard Deviation 20477

PRIMARY outcome

Timeframe: 24 months

Savings minus intervention costs. Presented in 2008 dollars.

Outcome measures

Measure	Treatment as Usual n=108 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=106 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=107 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Net Comparisons of Savings and Spendings Across Groups From Societal Perspective	-1545 US Dollars Standard Deviation 23195	838 US Dollars Standard Deviation 11018	-1497 US Dollars Standard Deviation 20414

PRIMARY outcome

Timeframe: 3 months (approximately study days 1 - 90)

Population: N's represent the participants at three months for whom complete Time Line Follow Back data was available.

Percent of days during the follow up that there was any cocaine use

Outcome measures

Measure	Treatment as Usual n=99 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=97 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=97 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Percent Days Cocaine Use	4.50 percentage of days Standard Error 1.53	4.25 percentage of days Standard Error 1.56	5.91 percentage of days Standard Error 1.80

PRIMARY outcome

Timeframe: 6 months (approproximately study days 91 - 180)

Population: N's represent the participants at three months for whom complete Time Line Follow Back data was available.

Percent of days during the follow up that there was any cocaine use

Outcome measures

Measure	Treatment as Usual n=98 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=91 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=94 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Percent Days Cocaine Use	6.60 percentage of days Standard Error 1.98	7.01 percentage of days Standard Error 2.14	11.66 percentage of days Standard Error 2.47

PRIMARY outcome

Timeframe: 9 months (approximately study days 181 - 270)

Population: N's represent the participants at three months for whom complete Time Line Follow Back data was available.

Percent of days during the follow up that there was any cocaine use

Outcome measures

Measure	Treatment as Usual n=93 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=87 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=91 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Percent Days Cocaine Use	6.96 percentage of days Standard Error 2.19	8.23 percentage of days Standard Error 2.22	5.43 percentage of days Standard Error 1.81

PRIMARY outcome

Timeframe: 12 months (approximately study days 271 - 365)

Population: N's represent the participants at three months for whom complete Time Line Follow Back data was available.

Percent of days during the follow up that there was any cocaine use

Outcome measures

Measure	Treatment as Usual n=91 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=87 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=91 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Percent Days Cocaine Use	5.58 percentage of days Standard Error 1.82	8.88 percentage of days Standard Error 2.38	7.89 percentage of days Standard Error 2.37

PRIMARY outcome

Timeframe: 18 months (approximately study days 366 - 546)

Population: N's represent the participants at three months for whom complete Time Line Follow Back data was available.

Percent of days during the follow up that there was any cocaine use

Outcome measures

Measure	Treatment as Usual n=81 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=82 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=84 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Percent Days Cocaine Use	5.13 percentage of days Standard Error 1.66	6.97 percentage of days Standard Error 1.98	5.18 percentage of days Standard Error 1.48

PRIMARY outcome

Timeframe: 24 months (approximately study days 547 - 730)

Population: N's represent the participants at three months for whom complete Time Line Follow Back data was available.

Percent of days during the follow up that there was any cocaine use

Outcome measures

Measure	Treatment as Usual n=77 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=82 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=80 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Percent Days Cocaine Use	9.80 percentage of days Standard Error 2.69	6.14 percentage of days Standard Error 2.06	6.01 percentage of days Standard Error 1.77

PRIMARY outcome

Timeframe: 3 months (approximately study days 1 - 90)

Population: N's represent the participants at three months for whom complete Time Line Follow Back data was available.

Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine

Outcome measures

Measure	Treatment as Usual n=99 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=97 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=97 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Percent Days Abstinent	94.01 percentage of days Standard Error 1.66	89.85 percentage of days Standard Error 2.45	92.70 percentage of days Standard Error 1.85

PRIMARY outcome

Timeframe: 6 months (approximately study days 91 - 180)

Population: N's represent the participants at three months for whom complete Time Line Follow Back data was available.

Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine

Outcome measures

Measure	Treatment as Usual n=98 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=91 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=94 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Percent Days Abstinent	90.20 percentage of days Standard Error 2.23	89.44 percentage of days Standard Error 2.41	85.61 percentage of days Standard Error 2.75

PRIMARY outcome

Timeframe: 9 months (approximately study days 181 - 270)

Population: N's represent the participants at three months for whom complete Time Line Follow Back data was available.

Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine

Outcome measures

Measure	Treatment as Usual n=93 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=87 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=91 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Percent Days Abstinent	88.16 percentage of days Standard Error 2.75	87.94 percentage of days Standard Error 2.64	91.79 percentage of days Standard Error 2.08

PRIMARY outcome

Timeframe: 12 months (approximately study days 271 - 365)

Population: N's represent the participants at three months for whom complete Time Line Follow Back data was available.

Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine

Outcome measures

Measure	Treatment as Usual n=91 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=87 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=91 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Percent Days Abstinent	88.91 percentage of days Standard Error 2.55	87.53 percentage of days Standard Error 2.68	89.60 percentage of days Standard Error 2.50

PRIMARY outcome

Timeframe: 18 months (approximately days 366 - 546)

Population: N's represent the participants at three months for whom complete Time Line Follow Back data was available.

Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine

Outcome measures

Measure	Treatment as Usual n=81 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=82 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=84 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Percent Days Abstinent	86.40 percentage of days Standard Error 3.03	88.58 percentage of days Standard Error 2.55	90.56 percentage of days Standard Error 1.96

PRIMARY outcome

Timeframe: 24 months (approximately study days 547 - 730)

Population: N's represent the participants at three months for whom complete Time Line Follow Back data was available.

Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine

Outcome measures

Measure	Treatment as Usual n=77 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=82 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=80 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Percent Days Abstinent	84.00 percentage of days Standard Error 3.45	88.88 percentage of days Standard Error 2.69	89.66 percentage of days Standard Error 2.42

SECONDARY outcome

Timeframe: 24 months

Population: Participants in TAU did not receive telephone counseling so were not included in these analyses. N's for TMAC and TMAC Plus represent participants who completed orientation.

Percent available sessions completed

Outcome measures

Measure	Treatment as Usual Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=69 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=82 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
Participation in Protocol	—	38.8 percentage of sessions Standard Deviation 31.9	67.1 percentage of sessions Standard Deviation 30.7

SECONDARY outcome

Timeframe: 12 months

Population: N's represent the participants at 12 months for whom we have a completed RAB (Risk Assessment Battery).

Risk score from RAB: Risk Assessment Battery. The RAB is a 41 - item self report developed to study the transmission of HIV. The Risk Assessment Battery generates a drug-risk score and a sex-risk score. For this study, the sex-risk score was used as the outcome measure of sexual behavior that is associated with HIV transmission. The sex-risk score ranges from 0 to 18, with 0 denoting no sex-risk and 18 denoting highest sex-risk. Previous research among drug using populations have found a sex-risk score mean of 6.2.

Outcome measures

Measure	Treatment as Usual n=79 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=74 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=77 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
HIV Sex Risk Score	2.9 units on a scale Standard Deviation 2.65	2.8 units on a scale Standard Deviation 2.10	2.7 units on a scale Standard Deviation 2.23

SECONDARY outcome

Timeframe: 24 months

Population: N's represent the participants at 24 months for whom we have a completed RAB (Risk Assessment Battery).

Risk score from RAB: Risk Assessment Battery. The RAB is a 41 - item self report developed to study the transmission of HIV. The Risk Assessment Battery generates a drug-risk score and a sex-risk score. For this study, the sex-risk score was used as the outcome measure of sexual behavior that is associated with HIV transmission. The sex-risk score ranges from 0 to 18, with 0 denoting no sex-risk and 18 denoting highest sex-risk. Previous research among drug using populations have found a sex-risk score mean of 6.2.

Outcome measures

Measure	Treatment as Usual n=70 Participants Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months	TMAC n=78 Participants Adaptive telephone-based counseling Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included	TMAC Plus n=77 Participants Adaptive telephone-based counseling, plus incentives Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included
HIV Sex Risk Score	2.7 units on a scale Standard Deviation 2.45	3 units on a scale Standard Deviation 2.74	2.7 units on a scale Standard Deviation 2.56

Adverse Events

Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

TMAC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

TMAC Plus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James R. McKay, Ph.D.

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