Clinical trial NCT02143063: Extending Long-term Outcomes Through an Adaptive Aftercare Intervention
Official title: Extending Long-term Outcomes Through an Adaptive Aftercare Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Use Disorder
Contingency Management
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-05-20
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Longest Duration of Abstinence From Cocaine
timeFrame: baseline through 6 months
Secondary outcomes:
measure: Longest Duration of Abstinence From All Substances Tested
timeFrame: baseline through 6 months
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Regional Network of Programs, Inc.
state: Connecticut
city: Hartford
country: United States
facility: Alcohol and Drug Recovery Centers, Inc.
state: Connecticut
city: New Britain
country: United States
facility: The Hospital of Central Connecticut at New Britain General
state: Connecticut
city: Springfield
country: United States
facility: Behavioral Health Network, Inc.
state: Massachusetts
Study officials:
affiliation: UConn Health
name: Nancy Petry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: