Extending Long-term Outcomes Through an Adaptive Aftercare Intervention

NCT ID: NCT02143063

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2020-10-31

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.

Conditions

Cocaine Use Disorder; Contingency Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard care

standard care

Group Type: ACTIVE_COMPARATOR

standard care

Intervention Type: BEHAVIORAL

standard care plus traditional contingency managment

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

standard care

Intervention Type: BEHAVIORAL

standard care plus variable interval contingency management

prize contingency management on a variable interval schedule for cocaine abstinence

Group Type: EXPERIMENTAL

prize contingency management on a variable interval schedule for cocaine abstinence

Intervention Type: BEHAVIORAL

standard care

Intervention Type: BEHAVIORAL

Interventions

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

Intervention Type: BEHAVIORAL

prize contingency management on a variable interval schedule for cocaine abstinence

Intervention Type: BEHAVIORAL

standard care

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Sheila Alessi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy Petry, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

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, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P50DA009241

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-090H-2

Identifier Type: -

Identifier Source: org_study_id