Cocaine Use Disorder, Contingency Management
Conditions
Brief summary
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
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.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longest Duration of Abstinence From Cocaine | baseline through 6 months | Longest duration of consecutive cocaine-negative urine toxicology tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Longest Duration of Abstinence From All Substances Tested | baseline through 6 months | Based on breath and urine toxicology tests (alcohol, methamphetamine, cocaine, opioids, THC, amphetamine, benzodiazepines) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care standard care
standard care | 61 |
| 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 | 105 |
| 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 | 108 |
| Total | 274 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 16 | 28 | 29 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Standard Care | Total | Standard Care Plus Variable Interval Contingency Management | Standard Care Plus Traditional Contingency Managment |
|---|---|---|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 9.2 | 40.1 years STANDARD_DEVIATION 9.7 | 39.7 years STANDARD_DEVIATION 10.1 | 40.7 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 64 Participants | 27 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 209 Participants | 81 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 81 Participants | 30 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 15 Participants | 6 Participants | 4 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 | 6 Participants | 26 Participants | 8 Participants | 12 Participants |
| Race (NIH/OMB) White | 33 Participants | 149 Participants | 64 Participants | 52 Participants |
| Region of Enrollment United States | 61 participants | 274 participants | 108 participants | 105 participants |
| Sex: Female, Male Female | 32 Participants | 147 Participants | 58 Participants | 57 Participants |
| Sex: Female, Male Male | 29 Participants | 127 Participants | 50 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 1 / 105 | 1 / 108 |
| other Total, other adverse events | 12 / 61 | 7 / 105 | 9 / 108 |
| serious Total, serious adverse events | 46 / 61 | 66 / 105 | 77 / 108 |
Outcome results
Longest Duration of Abstinence From Cocaine
Longest duration of consecutive cocaine-negative urine toxicology tests
Time frame: baseline through 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Longest Duration of Abstinence From Cocaine | 4.14 weeks |
| Standard Care Plus Traditional Contingency Managment | Longest Duration of Abstinence From Cocaine | 6.64 weeks |
| Standard Care Plus Variable Interval Contingency Management | Longest Duration of Abstinence From Cocaine | 6.93 weeks |
Longest Duration of Abstinence From All Substances Tested
Based on breath and urine toxicology tests (alcohol, methamphetamine, cocaine, opioids, THC, amphetamine, benzodiazepines)
Time frame: baseline through 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Longest Duration of Abstinence From All Substances Tested | 4.75 weeks |
| Standard Care Plus Traditional Contingency Managment | Longest Duration of Abstinence From All Substances Tested | 5.93 weeks |
| Standard Care Plus Variable Interval Contingency Management | Longest Duration of Abstinence From All Substances Tested | 5.71 weeks |