Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02143063 |
| Other study ID # |
14-090H-2 |
| Secondary ID |
P50DA009241 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 2014 |
| Est. completion date |
October 2020 |
Study information
| Verified date |
January 2022 |
| Source |
UConn Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
