Extending Long-term Outcomes Through an Adaptive Aftercare Intervention

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.

Study Overview

• Status: Completed
• Conditions: Contingency Management; Cocaine Use Disorder
• Intervention / Treatment: Behavioral: standard care; Behavioral: prize contingency management on a traditional twice weekly schedule for cocaine abstinence; Behavioral: prize contingency management on a variable interval schedule for cocaine abstinence

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.

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Regional Network of Programs, Inc.
    • Hartford, Connecticut, United States, 06112
      • Alcohol and Drug Recovery Centers, Inc.
    • New Britain, Connecticut, United States, 06050
      • The Hospital of Central Connecticut at New Britain General
  • Massachusetts
    • Springfield, Massachusetts, United States, 01104
      • Behavioral Health Network, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard care	Behavioral: standard care
Active Comparator: standard care plus traditional contingency managment; prize contingency management on a traditional twice weekly schedule for cocaine abstinence	Behavioral: standard care; Behavioral: prize contingency management on a traditional twice weekly schedule for cocaine abstinence
Experimental: standard care plus variable interval contingency management; prize contingency management on a variable interval schedule for cocaine abstinence	Behavioral: standard care; Behavioral: prize contingency management on a variable interval schedule for cocaine abstinence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longest Duration of Abstinence From Cocaine	Longest duration of consecutive cocaine-negative urine toxicology tests	baseline through 6 months

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Nancy Petry, Ph.D., UConn Health

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: May 16, 2014
• First Posted (Estimate): May 20, 2014

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Anesthetics, Local; Dopamine Uptake Inhibitors; Vasoconstrictor Agents; Cocaine
• Other Study ID Numbers: 14-090H-2; P50DA009241 (U.S. NIH Grant/Contract)