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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.


Recruitment information / eligibility

Status Completed
Enrollment 274
Est. completion date October 2020
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
prize contingency management on a traditional twice weekly schedule for cocaine abstinence

prize contingency management on a variable interval schedule for cocaine abstinence

standard care


Locations

Country Name City State
United States Regional Network of Programs, Inc. Bridgeport Connecticut
United States Alcohol and Drug Recovery Centers, Inc. Hartford Connecticut
United States The Hospital of Central Connecticut at New Britain General New Britain Connecticut
United States Behavioral Health Network, Inc. Springfield Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
UConn Health National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Longest Duration of Abstinence From Cocaine Longest duration of consecutive cocaine-negative urine toxicology tests baseline through 6 months
Secondary 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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