Cocaine Dependence
Conditions
Keywords
cocaine dependence, treatment, continuing care, outcomes, incentives, adaptive
Brief summary
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.
Detailed description
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.
Interventions
OTHERIntensive Outpatient Treatment
9 hours of group counseling per week for 2-3 months
OTHERAdaptive 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
OTHERAdaptive 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
Sponsors
National Institute on Drug Abuse (NIDA)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* qualify for a DSM-IV lifetime diagnosis of cocaine dependence and cocaine use in 6 months prior to treatment; * initial engagement in IOP, as indicated by attendance at 4 or more sessions in the first two weeks of treatment; * 18 to 75 years of age; * willingness to be randomized and participate in research. * metropolitan area residents; * able to provide the name, verified telephone number, and address of at least one contact who can provide locator information on the patient during follow-up.
Exclusion criteria
* current psychotic disorder or evidence of dementia severe enough to prevent participation in outpatient treatment; * acute medical problem requiring immediate inpatient treatment; * current participation in methadone or other forms of DA treatment, other than IOP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Days Abstinent | 3 months (approximately study days 1 - 90) | Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine |
| Net Comparisons of Savings and Spendings Across Groups From Societal Perspective | 24 months | Savings minus intervention costs. Presented in 2008 dollars. |
| Percent Days Cocaine Use | 3 months (approximately study days 1 - 90) | Percent of days during the follow up that there was any cocaine use |
| Abstinence | 3 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. |
| Cocaine Urine Toxicology | 3 month follow up | Positive cocaine test of urine |
| Comparison Across Groups in Societal Costs | 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. |
| Net Saving/Spending Comparisons Across Groups From Provider Perspective | 24 months | Savings minus intervention costs. Presented in 2008 dollars. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Sex Risk Score | 12 months | 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. |
| Participation in Protocol | 24 months | Percent available sessions completed |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 108 |
| 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 | 106 |
| 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 | 107 |
| Total | 321 |
Baseline characteristics
| Characteristic | Treatment as Usual | Total | TMAC Plus | TMAC |
|---|---|---|---|---|
| Age, Continuous | 42.9 years STANDARD_DEVIATION 8 | 43.2 years STANDARD_DEVIATION 7.43 | 43.4 years STANDARD_DEVIATION 6.48 | 43.3 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 12 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 105 Participants | 308 Participants | 104 Participants | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 97 Participants | 284 Participants | 98 Participants | 89 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 13 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) White | 8 Participants | 24 Participants | 6 Participants | 10 Participants |
| Region of Enrollment United States | 108 participants | 321 participants | 107 participants | 106 participants |
| Sex: Female, Male Female | 26 Participants | 76 Participants | 24 Participants | 26 Participants |
| Sex: Female, Male Male | 82 Participants | 245 Participants | 83 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 108 | 1 / 106 | 1 / 107 |
| other Total, other adverse events | 0 / 108 | 0 / 106 | 0 / 107 |
| serious Total, serious adverse events | 0 / 108 | 0 / 106 | 0 / 107 |
Outcome results
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.
Time frame: 6 month follow up
Population: The N analyzed represents that number of participants we reached for 6 month follow up evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Abstinence | 43 participants |
| TMAC | Abstinence | 44 participants |
| TMAC Plus | Abstinence | 42 participants |
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.
Time frame: 3 month follow up
Population: The N analyzed represents that number of people we reached for three month follow up evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Abstinence | 45 participants |
| TMAC | Abstinence | 57 participants |
| TMAC Plus | Abstinence | 45 participants |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Abstinence | 43 participants |
| TMAC | Abstinence | 44 participants |
| TMAC Plus | Abstinence | 39 participants |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Abstinence | 33 participants |
| TMAC | Abstinence | 39 participants |
| TMAC Plus | Abstinence | 42 participants |
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.
Time frame: 18 month follow up
Population: The N analyzed represents the number of participants we were able to reach for the 18 month follow up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Abstinence | 30 participants |
| TMAC | Abstinence | 27 participants |
| TMAC Plus | Abstinence | 34 participants |
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.
Time frame: 24 month follow up
Population: The N analyzed represents the number of participants we were able to reach for 24 month follow up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Abstinence | 20 participants |
| TMAC | Abstinence | 28 participants |
| TMAC Plus | Abstinence | 24 participants |
Primary
Cocaine Urine Toxicology
Positive cocaine test of urine
Time frame: 6 month follow up
Population: The N analyzed represents the number of participants for whom we had UDS results in month 6.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Cocaine Urine Toxicology | 0.26 proportion of participants positive |
| TMAC | Cocaine Urine Toxicology | 0.24 proportion of participants positive |
| TMAC Plus | Cocaine Urine Toxicology | 0.28 proportion of participants positive |
Primary
Cocaine Urine Toxicology
Positive cocaine test of urine
Time frame: 3 month follow up
Population: The N analyzed represents the number of participants for whom we had UDS results in month 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Cocaine Urine Toxicology | 0.31 proportion of participants positive |
| TMAC | Cocaine Urine Toxicology | 0.22 proportion of participants positive |
| TMAC Plus | Cocaine Urine Toxicology | 0.20 proportion of participants positive |
Primary
Cocaine Urine Toxicology
Positive cocaine test of urine
Time frame: 9 month follow up
Population: The N analyzed represents the number of participants for whom we had UDS results in month 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Cocaine Urine Toxicology | 0.30 proportion of participants positive |
| TMAC | Cocaine Urine Toxicology | 0.25 proportion of participants positive |
| TMAC Plus | Cocaine Urine Toxicology | 0.29 proportion of participants positive |
Primary
Cocaine Urine Toxicology
Positive cocaine test of urine
Time frame: 12 month follow up
Population: The N analyzed represents the number of participants for whom we had UDS results in month 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Cocaine Urine Toxicology | 0.37 proportion of participants positive |
| TMAC | Cocaine Urine Toxicology | 0.27 proportion of participants positive |
| TMAC Plus | Cocaine Urine Toxicology | 0.27 proportion of participants positive |
Primary
Cocaine Urine Toxicology
Positive cocaine test of urine
Time frame: 18 month follow up
Population: The N analyzed represents the number of participants for whom we had UDS results in month 18.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Cocaine Urine Toxicology | 0.33 proportion of participants positive |
| TMAC | Cocaine Urine Toxicology | 0.29 proportion of participants positive |
| TMAC Plus | Cocaine Urine Toxicology | 0.24 proportion of participants positive |
Primary
Cocaine Urine Toxicology
Positive cocaine test of urine
Time frame: 24 month follow up
Population: The N analyzed represents the number of participants for whom we had UDS results in month 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Cocaine Urine Toxicology | 038 proportion of participants positive |
| TMAC | Cocaine Urine Toxicology | 0.26 proportion of participants positive |
| TMAC Plus | Cocaine Urine Toxicology | 0.35 proportion of participants positive |
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.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Comparison Across Groups in Societal Costs | -1545 US Dollars | Standard Deviation 23195 |
| TMAC | Comparison Across Groups in Societal Costs | 1564 US Dollars | Standard Deviation 10997 |
| TMAC Plus | Comparison Across Groups in Societal Costs | -191 US Dollars | Standard Deviation 20514 |
Primary
Net Comparisons of Savings and Spendings Across Groups From Societal Perspective
Savings minus intervention costs. Presented in 2008 dollars.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Net Comparisons of Savings and Spendings Across Groups From Societal Perspective | -1545 US Dollars | Standard Deviation 23195 |
| TMAC | Net Comparisons of Savings and Spendings Across Groups From Societal Perspective | 838 US Dollars | Standard Deviation 11018 |
| TMAC Plus | Net Comparisons of Savings and Spendings Across Groups From Societal Perspective | -1497 US Dollars | Standard Deviation 20414 |
Primary
Net Saving/Spending Comparisons Across Groups From Provider Perspective
Savings minus intervention costs. Presented in 2008 dollars.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Net Saving/Spending Comparisons Across Groups From Provider Perspective | -1545 US Dollars | Standard Deviation 23195 |
| TMAC | Net Saving/Spending Comparisons Across Groups From Provider Perspective | 1222 US Dollars | Standard Deviation 11000 |
| TMAC Plus | Net Saving/Spending Comparisons Across Groups From Provider Perspective | -750 US Dollars | Standard Deviation 20477 |
Primary
Percent Days Abstinent
Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Percent Days Abstinent | 84.00 percentage of days | Standard Error 3.45 |
| TMAC | Percent Days Abstinent | 88.88 percentage of days | Standard Error 2.69 |
| TMAC Plus | Percent Days Abstinent | 89.66 percentage of days | Standard Error 2.42 |
Primary
Percent Days Abstinent
Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Percent Days Abstinent | 94.01 percentage of days | Standard Error 1.66 |
| TMAC | Percent Days Abstinent | 89.85 percentage of days | Standard Error 2.45 |
| TMAC Plus | Percent Days Abstinent | 92.70 percentage of days | Standard Error 1.85 |
Primary
Percent Days Abstinent
Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Percent Days Abstinent | 90.20 percentage of days | Standard Error 2.23 |
| TMAC | Percent Days Abstinent | 89.44 percentage of days | Standard Error 2.41 |
| TMAC Plus | Percent Days Abstinent | 85.61 percentage of days | Standard Error 2.75 |
Primary
Percent Days Abstinent
Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Percent Days Abstinent | 88.16 percentage of days | Standard Error 2.75 |
| TMAC | Percent Days Abstinent | 87.94 percentage of days | Standard Error 2.64 |
| TMAC Plus | Percent Days Abstinent | 91.79 percentage of days | Standard Error 2.08 |
Primary
Percent Days Abstinent
Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Percent Days Abstinent | 88.91 percentage of days | Standard Error 2.55 |
| TMAC | Percent Days Abstinent | 87.53 percentage of days | Standard Error 2.68 |
| TMAC Plus | Percent Days Abstinent | 89.60 percentage of days | Standard Error 2.5 |
Primary
Percent Days Abstinent
Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Percent Days Abstinent | 86.40 percentage of days | Standard Error 3.03 |
| TMAC | Percent Days Abstinent | 88.58 percentage of days | Standard Error 2.55 |
| TMAC Plus | Percent Days Abstinent | 90.56 percentage of days | Standard Error 1.96 |
Primary
Percent Days Cocaine Use
Percent of days during the follow up that there was any cocaine use
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Percent Days Cocaine Use | 5.58 percentage of days | Standard Error 1.82 |
| TMAC | Percent Days Cocaine Use | 8.88 percentage of days | Standard Error 2.38 |
| TMAC Plus | Percent Days Cocaine Use | 7.89 percentage of days | Standard Error 2.37 |
Primary
Percent Days Cocaine Use
Percent of days during the follow up that there was any cocaine use
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Percent Days Cocaine Use | 5.13 percentage of days | Standard Error 1.66 |
| TMAC | Percent Days Cocaine Use | 6.97 percentage of days | Standard Error 1.98 |
| TMAC Plus | Percent Days Cocaine Use | 5.18 percentage of days | Standard Error 1.48 |
Primary
Percent Days Cocaine Use
Percent of days during the follow up that there was any cocaine use
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Percent Days Cocaine Use | 9.80 percentage of days | Standard Error 2.69 |
| TMAC | Percent Days Cocaine Use | 6.14 percentage of days | Standard Error 2.06 |
| TMAC Plus | Percent Days Cocaine Use | 6.01 percentage of days | Standard Error 1.77 |
Primary
Percent Days Cocaine Use
Percent of days during the follow up that there was any cocaine use
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Percent Days Cocaine Use | 4.50 percentage of days | Standard Error 1.53 |
| TMAC | Percent Days Cocaine Use | 4.25 percentage of days | Standard Error 1.56 |
| TMAC Plus | Percent Days Cocaine Use | 5.91 percentage of days | Standard Error 1.8 |
Primary
Percent Days Cocaine Use
Percent of days during the follow up that there was any cocaine use
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Percent Days Cocaine Use | 6.60 percentage of days | Standard Error 1.98 |
| TMAC | Percent Days Cocaine Use | 7.01 percentage of days | Standard Error 2.14 |
| TMAC Plus | Percent Days Cocaine Use | 11.66 percentage of days | Standard Error 2.47 |
Primary
Percent Days Cocaine Use
Percent of days during the follow up that there was any cocaine use
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Percent Days Cocaine Use | 6.96 percentage of days | Standard Error 2.19 |
| TMAC | Percent Days Cocaine Use | 8.23 percentage of days | Standard Error 2.22 |
| TMAC Plus | Percent Days Cocaine Use | 5.43 percentage of days | Standard Error 1.81 |
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.
Time frame: 12 months
Population: N's represent the participants at 12 months for whom we have a completed RAB (Risk Assessment Battery).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | HIV Sex Risk Score | 2.9 units on a scale | Standard Deviation 2.65 |
| TMAC | HIV Sex Risk Score | 2.8 units on a scale | Standard Deviation 2.1 |
| TMAC Plus | HIV Sex Risk Score | 2.7 units on a scale | Standard Deviation 2.23 |
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.
Time frame: 24 months
Population: N's represent the participants at 24 months for whom we have a completed RAB (Risk Assessment Battery).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | HIV Sex Risk Score | 2.7 units on a scale | Standard Deviation 2.45 |
| TMAC | HIV Sex Risk Score | 3 units on a scale | Standard Deviation 2.74 |
| TMAC Plus | HIV Sex Risk Score | 2.7 units on a scale | Standard Deviation 2.56 |
Secondary
Participation in Protocol
Percent available sessions completed
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMAC | Participation in Protocol | 38.8 percentage of sessions | Standard Deviation 31.9 |
| TMAC Plus | Participation in Protocol | 67.1 percentage of sessions | Standard Deviation 30.7 |