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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA020623 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study tests the effectiveness of two 24 month, telephone-based adaptive continuing care interventions for patients with cocaine dependence. The two interventions are predicted to produce better drug use outcomes than standard care. Furthermore, the intervention that also includes monetary incentives for continued participation is hypothesized to produce better retention and drug use outcomes than the intervention without incentives. Economic analyses will determine the cost-effectiveness and benefit-cost of the interventions relative to standard care, and to each other.
There is considerable evidence that treatment for drug use disorders can lead to substantial improvements in substance use and psychosocial problem severity. However, a significant percentage of patients relapse to problematic levels of substance use after primary treatment, and require additional treatment episodes. Patients are therefore frequently referred to continuing care programs to prevent relapse and decrease the probability of additional rehabilitation treatments. However, current models of continuing care may not be adequate for the long-term management of a chronic, relapsing disorder such as substance dependence. One possible approach for improving the management of drug dependence is adaptive treatment regimes, which combine low intensity monitoring and counseling when patients are doing well with stepped care protocols to increase the intensity of treatment when warranted by deteriorations in status and functioning. However, addiction management protocols may require incentives and other features to make long-term participation more appealing.
Cocaine dependent patients who have completed 2 weeks of intensive outpatient treatment (IOP) will be randomly assigned to one of the following interventions: (1) continued participation in IOP without additional intervention (TAU); (2) TAU plus an adaptive protocol that includes monitoring, feedback, and brief counseling via telephone on a tapered schedule out to 24 months, and more intensive face-to-face treatment when warranted (TMAC); or (3) TAU and the adaptive protocol, plus incentives for sustained participation (TMAC-Plus). Patients will be followed up at 3, 6, 9, 12, 18, and 24 months post intake into the study. Follow-up assessments will include measures of drug use, treatment process and potential mediating factors, psychosocial problem severity, utilization of health and social services, and costs.
The two adaptive extended interventions (TMAC and TMAC-Plus) are predicted to produce better drug use outcomes than TAU. TMAC-Plus is hypothesized to produce better retention and drug use outcomes than TMAC. Economic analyses will determine the cost-effectiveness and benefit-cost of TMAC and TMF-Plus relative to TAU, and to each other. Other analyses will test mediation hypotheses, examine potential moderator effects, and test the impact of disease management on HIV risk behaviors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAU only | Active Comparator | Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) |
|
| TMAC only | Experimental | Adaptive telephone-based counseling |
|
| TMAC plus | Experimental | Adaptive telephone-based counseling, plus incentives |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Outpatient Treatment | Other | 9 hours of group counseling per week for 2-3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence | 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. | 3 month follow up |
| Abstinence | 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. | 6 month follow up |
| Abstinence | 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. | 9 month follow up |
| Abstinence | 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. | 12 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Participation in Protocol | Percent available sessions completed | 24 months |
| HIV Sex Risk Score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James R McKay, Ph.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Presbyterian Hospital | Philadelphia | Pennsylvania | 19104 | United States | ||
| NorthEast Treatment Centers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24041231 | Result | McKay JR, Van Horn DH, Lynch KG, Ivey M, Cary MS, Drapkin ML, Coviello DM, Plebani JG. An adaptive approach for identifying cocaine dependent patients who benefit from extended continuing care. J Consult Clin Psychol. 2013 Dec;81(6):1063-73. doi: 10.1037/a0034265. Epub 2013 Sep 16. | |
| 24355401 | Result | McKay JR, Van Horn DH, Lynch KG, Ivey M, Cary MS, Drapkin M, Coviello D. Who benefits from extended continuing care for cocaine dependence? Addict Behav. 2014 Mar;39(3):660-8. doi: 10.1016/j.addbeh.2013.11.019. Epub 2013 Dec 1. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | TMAC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Abstinence | 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. | The N analyzed represents that number of people we reached for three month follow up evaluation. | Posted | Number | participants | 3 month follow up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James R. McKay, Ph.D. | University of Pennsylvania | 215-746-7704 | jimrache@mail.med.upenn.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Adaptive telephone-based counseling |
| Other |
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 |
|
| Adaptive telephone-based counseling plus incentives | Other | 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 | 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. | 18 month follow up |
| Abstinence | 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. | 24 month follow up |
| Cocaine Urine Toxicology | Positive cocaine test of urine | 3 month follow up |
| Cocaine Urine Toxicology | Positive cocaine test of urine | 6 month follow up |
| Cocaine Urine Toxicology | Positive cocaine test of urine | 9 month follow up |
| Cocaine Urine Toxicology | Positive cocaine test of urine | 12 month follow up |
| Cocaine Urine Toxicology | Positive cocaine test of urine | 18 month follow up |
| Cocaine Urine Toxicology | Positive cocaine test of urine | 24 month follow up |
| Comparison Across Groups in Societal Costs | 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. | 24 months |
| Net Saving/Spending Comparisons Across Groups From Provider Perspective | Savings minus intervention costs. Presented in 2008 dollars. | 24 months |
| Net Comparisons of Savings and Spendings Across Groups From Societal Perspective | Savings minus intervention costs. Presented in 2008 dollars. | 24 months |
| Percent Days Cocaine Use | Percent of days during the follow up that there was any cocaine use | 3 months (approximately study days 1 - 90) |
| Percent Days Cocaine Use | Percent of days during the follow up that there was any cocaine use | 6 months (approproximately study days 91 - 180) |
| Percent Days Cocaine Use | Percent of days during the follow up that there was any cocaine use | 9 months (approximately study days 181 - 270) |
| Percent Days Cocaine Use | Percent of days during the follow up that there was any cocaine use | 12 months (approximately study days 271 - 365) |
| Percent Days Cocaine Use | Percent of days during the follow up that there was any cocaine use | 18 months (approximately study days 366 - 546) |
| Percent Days Cocaine Use | Percent of days during the follow up that there was any cocaine use | 24 months (approximately study days 547 - 730) |
| Percent Days Abstinent | Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine | 3 months (approximately study days 1 - 90) |
| Percent Days Abstinent | Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine | 6 months (approximately study days 91 - 180) |
| Percent Days Abstinent | Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine | 9 months (approximately study days 181 - 270) |
| Percent Days Abstinent | Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine | 12 months (approximately study days 271 - 365) |
| Percent Days Abstinent | Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine | 18 months (approximately days 366 - 546) |
| Percent Days Abstinent | Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine | 24 months (approximately study days 547 - 730) |
| 12 months |
| HIV Sex Risk Score | 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. | 24 months |
| Philadelphia |
| Pennsylvania |
| 19123 |
| United States |
| 23561331 | Result | McKay JR, Van Horn D, Rennert L, Drapkin M, Ivey M, Koppenhaver J. Factors in sustained recovery from cocaine dependence. J Subst Abuse Treat. 2013 Aug;45(2):163-72. doi: 10.1016/j.jsat.2013.02.007. Epub 2013 Apr 2. |
| 21041041 | Result | Van Horn DH, Drapkin M, Ivey M, Thomas T, Domis SW, Abdalla O, Herd D, McKay JR. Voucher incentives increase treatment participation in telephone-based continuing care for cocaine dependence. Drug Alcohol Depend. 2011 Apr 1;114(2-3):225-8. doi: 10.1016/j.drugalcdep.2010.09.007. Epub 2010 Nov 1. |
| 27224980 | Result | Wimberly AS, Ivey M, Rennert L, McKay JR. Effect of Continuing Care for Cocaine Dependence on HIV Sex-Risk Behaviors. AIDS Behav. 2017 Apr;21(4):1082-1090. doi: 10.1007/s10461-016-1434-6. |
| 26621551 | Result | McCollister K, Yang X, McKay JR. Cost-effectiveness analysis of a continuing care intervention for cocaine-dependent adults. Drug Alcohol Depend. 2016 Jan 1;158:38-44. doi: 10.1016/j.drugalcdep.2015.10.032. Epub 2015 Nov 12. |
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
| OG002 | 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 |
|
|
| Primary | Abstinence | 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. | The N analyzed represents that number of participants we reached for 6 month follow up evaluation. | Posted | Number | participants | 6 month follow up |
|
|
|
| Primary | Abstinence | 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. | The N analyzed represents the number of participants we were able to reach for the 9 month follow up evaluation. | Posted | Number | participants | 9 month follow up |
|
|
|
| Primary | Abstinence | 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. | The N analyzed represents the number of participants we were able to reach at the 12 month follow up for evaluation. | Posted | Number | participants | 12 month follow up |
|
|
|
| Primary | Abstinence | 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. | The N analyzed represents the number of participants we were able to reach for the 18 month follow up. | Posted | Number | participants | 18 month follow up |
|
|
|
| Primary | Abstinence | 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. | The N analyzed represents the number of participants we were able to reach for 24 month follow up. | Posted | Number | participants | 24 month follow up |
|
|
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| Primary | Cocaine Urine Toxicology | Positive cocaine test of urine | The N analyzed represents the number of participants for whom we had UDS results in month 3. | Posted | Number | proportion of participants positive | 3 month follow up |
|
|
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| Primary | Cocaine Urine Toxicology | Positive cocaine test of urine | The N analyzed represents the number of participants for whom we had UDS results in month 6. | Posted | Number | proportion of participants positive | 6 month follow up |
|
|
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| Primary | Cocaine Urine Toxicology | Positive cocaine test of urine | The N analyzed represents the number of participants for whom we had UDS results in month 9. | Posted | Number | proportion of participants positive | 9 month follow up |
|
|
|
| Primary | Cocaine Urine Toxicology | Positive cocaine test of urine | The N analyzed represents the number of participants for whom we had UDS results in month 12. | Posted | Number | proportion of participants positive | 12 month follow up |
|
|
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| Primary | Cocaine Urine Toxicology | Positive cocaine test of urine | The N analyzed represents the number of participants for whom we had UDS results in month 18. | Posted | Number | proportion of participants positive | 18 month follow up |
|
|
|
| Primary | Cocaine Urine Toxicology | Positive cocaine test of urine | The N analyzed represents the number of participants for whom we had UDS results in month 24. | Posted | Number | proportion of participants positive | 24 month follow up |
|
|
|
| Primary | Comparison Across Groups in Societal Costs | 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. | Posted | Mean | Standard Deviation | US Dollars | 24 months |
|
|
|
| Primary | Net Saving/Spending Comparisons Across Groups From Provider Perspective | Savings minus intervention costs. Presented in 2008 dollars. | Posted | Mean | Standard Deviation | US Dollars | 24 months |
|
|
|
| Primary | Net Comparisons of Savings and Spendings Across Groups From Societal Perspective | Savings minus intervention costs. Presented in 2008 dollars. | Posted | Mean | Standard Deviation | US Dollars | 24 months |
|
|
|
| Secondary | Participation in Protocol | Percent available sessions completed | 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. | Posted | Mean | Standard Deviation | percentage of sessions | 24 months |
|
|
|
| Secondary | HIV Sex Risk Score | 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. | N's represent the participants at 12 months for whom we have a completed RAB (Risk Assessment Battery). | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | HIV Sex Risk Score | 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. | N's represent the participants at 24 months for whom we have a completed RAB (Risk Assessment Battery). | Posted | Mean | Standard Deviation | units on a scale | 24 months |
|
|
|
| Primary | Percent Days Cocaine Use | Percent of days during the follow up that there was any cocaine use | N's represent the participants at three months for whom complete Time Line Follow Back data was available. | Posted | Mean | Standard Error | percentage of days | 3 months (approximately study days 1 - 90) |
|
|
|
| Primary | Percent Days Cocaine Use | Percent of days during the follow up that there was any cocaine use | N's represent the participants at three months for whom complete Time Line Follow Back data was available. | Posted | Mean | Standard Error | percentage of days | 6 months (approproximately study days 91 - 180) |
|
|
|
| Primary | Percent Days Cocaine Use | Percent of days during the follow up that there was any cocaine use | N's represent the participants at three months for whom complete Time Line Follow Back data was available. | Posted | Mean | Standard Error | percentage of days | 9 months (approximately study days 181 - 270) |
|
|
|
| Primary | Percent Days Cocaine Use | Percent of days during the follow up that there was any cocaine use | N's represent the participants at three months for whom complete Time Line Follow Back data was available. | Posted | Mean | Standard Error | percentage of days | 12 months (approximately study days 271 - 365) |
|
|
|
| Primary | Percent Days Cocaine Use | Percent of days during the follow up that there was any cocaine use | N's represent the participants at three months for whom complete Time Line Follow Back data was available. | Posted | Mean | Standard Error | percentage of days | 18 months (approximately study days 366 - 546) |
|
|
|
| Primary | Percent Days Cocaine Use | Percent of days during the follow up that there was any cocaine use | N's represent the participants at three months for whom complete Time Line Follow Back data was available. | Posted | Mean | Standard Error | percentage of days | 24 months (approximately study days 547 - 730) |
|
|
|
| Primary | Percent Days Abstinent | Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine | N's represent the participants at three months for whom complete Time Line Follow Back data was available. | Posted | Mean | Standard Error | percentage of days | 3 months (approximately study days 1 - 90) |
|
|
|
| Primary | Percent Days Abstinent | Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine | N's represent the participants at three months for whom complete Time Line Follow Back data was available. | Posted | Mean | Standard Error | percentage of days | 6 months (approximately study days 91 - 180) |
|
|
|
| Primary | Percent Days Abstinent | Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine | N's represent the participants at three months for whom complete Time Line Follow Back data was available. | Posted | Mean | Standard Error | percentage of days | 9 months (approximately study days 181 - 270) |
|
|
|
| Primary | Percent Days Abstinent | Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine | N's represent the participants at three months for whom complete Time Line Follow Back data was available. | Posted | Mean | Standard Error | percentage of days | 12 months (approximately study days 271 - 365) |
|
|
|
| Primary | Percent Days Abstinent | Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine | N's represent the participants at three months for whom complete Time Line Follow Back data was available. | Posted | Mean | Standard Error | percentage of days | 18 months (approximately days 366 - 546) |
|
|
|
| Primary | Percent Days Abstinent | Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine | N's represent the participants at three months for whom complete Time Line Follow Back data was available. | Posted | Mean | Standard Error | percentage of days | 24 months (approximately study days 547 - 730) |
|
|
|
| 2 |
| 108 |
| 0 |
| 108 |
| 0 |
| 108 |
| EG001 | 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 | 1 | 106 | 0 | 106 | 0 | 106 |
| EG002 | 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 | 1 | 107 | 0 | 107 | 0 | 107 |
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