Extending Long-term Outcomes Through an Adaptive Aftercare Intervention

Study Overview
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Brief Summary
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Reinforcement interventions have pronounced effects on reducing cocaine use. This study will evaluate a novel approach in which reinforcement frequency varies by patient performance. To test efficacy, 280 patients with cocaine use disorder will be randomly assigned to: standard care, standard care plus traditional twice weekly reinforcement, or standard care plus adaptive variable interval reinforcement.

Detailed Description
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Reinforcement interventions have pronounced effects on reducing cocaine use. We developed and evaluated a low-cost reinforcement intervention, systematically moving it through the Stages of development to dissemination and broad clinical implementation. In an ongoing project, reinforcement interventions are yielding benefits when reinforcers are provided at treatment initiation and for longer durations. However, less than half of patients remain engaged for 12 weeks with traditional reinforcement interventions, which require frequent attendance for monitoring and reinforcing abstinence. Interventions that extend into aftercare and that are acceptable to and efficacious in preventing long-term relapse are critically needed. Reinforcement interventions are efficacious during periods they are in effect, and pilot data show that variable interval (VI) reinforcement schedules, once behavior change occurs, hold potential for maintaining gains when administered infrequently. Assessing methods to extend benefits of these interventions is of paramount scientific and clinical concern. This study will evaluate a novel approach in which reinforcement frequency varies by patient performance. In this intervention, reinforcement will be available for 24 weeks, on a progressive VI schedule, that adapts according to patient status. Patients who maintain abstinence earn maximum reinforcers as infrequently as every three weeks on average, while frequency of monitoring and reinforcing abstinence will increase in those who relapse until abstinence is re-instated. To test efficacy, 280 patients with cocaine use disorder will be randomly assigned to: standard care (SC), SC+traditional twice weekly reinforcement, or SC+adaptive VI reinforcement. Evaluations will be completed at baseline and throughout 18 months to assess objective and self-reported indices of drug use, psychosocial problems, and HIV risk behaviors. Primary hypotheses are (1) the adaptive VI reinforcement intervention will improve outcomes relative to standard care during the treatment period and throughout follow-up, and (2) the adaptive VI reinforcement intervention will improve outcomes relative to the traditional reinforcement system. This study will also evaluate the roles of cognitive control and treatment outcome. Patients with better cognitive control are expected to maintain longer durations of abstinence across conditions. If these measures differentially relate to outcomes across treatments, such results suggest the potential of pairing reinforcement interventions to individuals most likely to benefit from them; they may also indicate possible markers of response in a treatment-specific manner. If cognitive indices mediate treatment response, future studies can refine interventions to improve cognitive processes and long-term outcomes.

Official Title
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Extending Long-term Outcomes Through an Adaptive Aftercare Intervention

Conditions
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Cocaine Use Disorder, Contingency Management

Intervention / Treatment
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* Behavioral: prize contingency management on a traditional twice weekly schedule for cocaine abstinence
* Behavioral: prize contingency management on a variable interval schedule for cocaine abstinence
* Behavioral: standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be age 18 years or older have a cocaine use disorder diagnosis be willing to sign informed consent and able to pass an informed consent quiz Exclusion Criteria: serious, uncontrolled psychiatric illness in recovery from pathological gambling do not speak English

Ages Eligible for Study
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Minimum Age: 18 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: standard care<br>standard care | Behavioral: standard care<br> <br> |
| Active Comparator: standard care plus traditional contingency managment<br>prize contingency management on a traditional twice weekly schedule for cocaine abstinence | Behavioral: prize contingency management on a traditional twice weekly schedule for cocaine abstinence<br> <br> Behavioral: standard care<br> <br> |
| Experimental: standard care plus variable interval contingency management<br>prize contingency management on a variable interval schedule for cocaine abstinence | Behavioral: prize contingency management on a variable interval schedule for cocaine abstinence<br> <br> Behavioral: standard care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longest Duration of Abstinence From Cocaine | Longest duration of consecutive cocaine-negative urine toxicology tests | baseline through 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longest Duration of Abstinence From All Substances Tested | Based on breath and urine toxicology tests (alcohol, methamphetamine, cocaine, opioids, THC, amphetamine, benzodiazepines) | baseline through 6 months |