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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA009241 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard care | Active Comparator | standard care |
|
| standard care plus traditional contingency managment | Active Comparator | prize contingency management on a traditional twice weekly schedule for cocaine abstinence |
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| standard care plus variable interval contingency management | Experimental | prize contingency management on a variable interval schedule for cocaine abstinence |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prize contingency management on a traditional twice weekly schedule for cocaine abstinence | Behavioral |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Longest Duration of Abstinence From Cocaine | Longest duration of consecutive cocaine-negative urine toxicology tests | baseline through 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Petry, Ph.D. | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Network of Programs, Inc. | Bridgeport | Connecticut | 06610 | United States | ||
| Alcohol and Drug Recovery Centers, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care (SC) | Standard care IOP treatment for cocaine use disorder. In addition, SC participants submitted urine samples during the 24-week intervention phase. Patients selected two days a week on which drug screens might occur (e.g., M/Th, T/F). On the morning of each potential drug screen day, research staff texted participants to indicate if a sample was due. In weeks 1-3, urine screens occurred on two days per week. In weeks 4-9, screens occurred on one randomly selected day each week. In weeks 10-24, drug screens occurred once every 2-3 weeks on average. After a missed sample, the next two screen days were prompted for sample submission. An algorithm developed in-house was used to generate and monitor the drug screen schedule. Participants received $2 per requested sample submitted plus a $20 bonus for submitting all requested samples in a 4-week period. The goal was to result in 18 samples on average, equivalent relative to the new SC plus variable interval CM condition. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2020 |
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| prize contingency management on a variable interval schedule for cocaine abstinence |
| Behavioral |
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| standard care | Behavioral |
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| Hartford |
| Connecticut |
| 06112 |
| United States |
| The Hospital of Central Connecticut at New Britain General | New Britain | Connecticut | 06050 | United States |
| Behavioral Health Network, Inc. | Springfield | Massachusetts | 01104 | United States |
| FG001 | Standard Care Plus Traditional Contingency Management | Standard care plus "standard" prize contingency management twice weekly for urine screens indicating cocaine abstinence. Urine screens occurred on the same monitoring schedule described for the SC condition, including $2 per requested sample submitted and a $20 bonus for all requested samples in a 4-week period. In addition, participants received chances for prizes on a escalating reinforcement schedule and with a reset condition for unexcused missed samples. Mean maximum earnings for cocaine-negative urine screens was $460 in prizes. |
| FG002 | Standard Care Plus Variable Interval Contingency Management | Standard care plus prize contingency management on a variable interval schedule for cocaine abstinence. Relative to the traditional CM condition, in this condition, the frequency of samples to earn reinforcement decreased over time contingent on achieving periods of sustained abstinence. The schedule was designed to result in an average of at least 18 urine samples over 24 weeks among participants maintaining abstinence. Participants received the sample compensation for submitted urine samples regardless of results as in the other two conditions. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | standard care standard care |
| BG001 | Standard Care Plus Traditional Contingency Managment | prize contingency management on a traditional twice weekly schedule for cocaine abstinence prize contingency management on a traditional twice weekly schedule for cocaine abstinence standard care |
| BG002 | Standard Care Plus Variable Interval Contingency Management | prize contingency management on a variable interval schedule for cocaine abstinence prize contingency management on a variable interval schedule for cocaine abstinence standard care |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Longest Duration of Abstinence From Cocaine | Longest duration of consecutive cocaine-negative urine toxicology tests | Posted | Median | Inter-Quartile Range | weeks | baseline through 6 months |
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| Secondary | Longest Duration of Abstinence From All Substances Tested | Based on breath and urine toxicology tests (alcohol, methamphetamine, cocaine, opioids, THC, amphetamine, benzodiazepines) | Posted | Median | Inter-Quartile Range | weeks | baseline through 6 months |
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18 months
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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 | Standard Care | standard care standard care | 0 | 61 | 46 | 61 | 12 | 61 |
| EG001 | Standard Care Plus Traditional Contingency Managment | prize contingency management on a traditional twice weekly schedule for cocaine abstinence prize contingency management on a traditional twice weekly schedule for cocaine abstinence standard care | 1 | 105 | 66 | 105 | 7 | 105 |
| EG002 | Standard Care Plus Variable Interval Contingency Management | prize contingency management on a variable interval schedule for cocaine abstinence prize contingency management on a variable interval schedule for cocaine abstinence standard care | 1 | 108 | 77 | 108 | 9 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient substance use treatment | Social circumstances | Systematic Assessment |
| ||
| Inpatient psychiatric treatment | Psychiatric disorders | Systematic Assessment |
| ||
| Inpatient medical treatment | General disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
| ||
| ER visit for overdose | General disorders | Systematic Assessment |
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Analyses presented assessed outcomes at the group-level and using main a priori analytic methods. Additional analyses should assess outcomes in the context of potential baseline predictors, assess for patterns in individual-level trajectories over time and by group, and incorporate additional advanced analytic techniques.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheila Alessi, PhD | UConn Health | 860-679-1849 | salessi@uchc.edu |
| Oct 18, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 19, 2018 | Oct 18, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| comparison of rank sum |
| 5287.5 |
| 2-Sided |
| Superiority |
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|