Effectiveness of Extended Treatments for Drug Dependence

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Extended Treatments for Drug Dependence

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Other: Intensive Outpatient Treatment
* Other: Adaptive telephone-based counseling
* Other: Adaptive telephone-based counseling plus incentives


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAU only<br>Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long) | Other: Intensive Outpatient Treatment<br>* 9 hours of group counseling per week for 2-3 months<br>|
| Experimental: TMAC only<br>Adaptive telephone-based counseling | Other: Adaptive telephone-based counseling<br>* 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<br>|
| Experimental: TMAC plus<br>Adaptive telephone-based counseling, plus incentives | Other: Adaptive telephone-based counseling plus incentives<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cocaine dependence, treatment, continuing care, outcomes, incentives, adaptive