Clinical trial NCT05702021: Implementing Contingency Management for Stimulant Use in Specialty Addiction Treatment Organizations
Official title: Implementing Contingency Management for Stimulant Use in Specialty Addiction Treatment Organizations (Center for Dissemination and Implementation Science at Stanford, Research Component #2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stimulant Use (Diagnosis)
Keywords: Stimulants
Contingency management
Opioid Use Disorder
Implementation science
Behavior change
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Stanford University
name: Ohio State University
First posted: 2023-01-27
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Stimulants constitute a new and deadly fourth wave of the opioid epidemic. Contingency management is the most effective intervention for stimulant use and is an evidence-based adjunct to medication for opioid use disorder. Yet, uptake of contingency management in opioid treatment programs that provide medication for opioid use disorder remains low; in fact, access to contingency management is arguably one of the greatest research-to-practice gaps in the addiction treatment services field. The goal of this study is to conduct a type III hybrid effectiveness-implementation trial to evaluate a multi-level implementation strategy, the Science of Service Laboratory, to install contingency management for stimulant use in opioid treatment programs. The Science of Service Laboratory has three core components: didactic training, performance feedback, and external facilitation.

Utilizing a stepped wedge design, a regional cohort of 10 public sector opioid treatment programs will be randomized to receive Science of Service Laboratory at five distinct time points. At six intervals, each of the 10 opioid treatment programs will provide de-identified electronic medical record data from all available patient charts on contingency management delivery and patient outcomes. Staff from each opioid treatment program will provide feedback on contextual determinants influencing implementation. This study will rigorously evaluate whether a multi-level implementation strategy developed by one of the longest-standing national intermediary purveyor organizations-the SAMHSA Technology Transfer Centers, will improve both implementation and patient outcomes.

Detailed description: Stimulant use among persons with opioid use disorder is associated with an array of serious consequences. Among those with opioid use disorder, stimulant use has been associated with more persistent opioid use; higher risk of HIV infection; higher levels of family, medical, legal, and vocational problems; and increased risk of fatal overdose. Contingency management is an evidence-based intervention for stimulant use and an evidence-based adjunct to medication for opioid use disorders. Medication for opioid use disorder is the first-line, evidence-based treatment for opioid use disorder, but does not specifically reduce stimulant use, and there are not yet efficacious medications for stimulant addiction. Moreover, individuals who continue to use stimulants while receiving medication for opioid use disorder have worse treatment response in terms of both retention and abstinence from opioids. Contingency management targets stimulant use via reinforcing incentives for attaining abstinence. Despite an abundance of research evidence, contingency management uptake in opioid treatment programs remains low due to barriers at both the provider- and organizational-levels. Effectively addressing the contingency management evidence-to-practice gap could advance both the field of implementation science and the quality of care in specialty addiction treatment settings. This project evaluates a multi-level implementation strategy, the Science to Service Laboratory, to install contingency management for stimulant use in opioid treatment programs. The Science of Service Laboratory employs three core components: didactic training; performance feedback; and external facilitation.

Utilizing a fully powered type III hybrid effectiveness-implementation trial with a stepped wedge design, we will randomize a cohort of 10 public sector opioid treatment programs in New England to receive the Science of Service Laboratory at five time points. Data collection will leverage multiple sources. At six intervals, each of the 10 opioid treatment programs will extract de-identified electronic medical record data on contingency management implementation and patient outcomes. In addition, opioid treatment program staff will report on contextual determinants of implementation. Results will evaluate whether a multi-level implementation strategy initially developed by one of the longest-standing intermediary purveyor organizations (SAMHSA Technology Transfer Centers), will improve implementation and patient outcomes. In addition, the project will ensure equitable service provision to diverse, high-risk patients while advancing implementation science via specification and evaluation of contextual determinants.

The Specific Aims and corresponding hypotheses are:

Specific Aim 1: To test the effectiveness of the Science of Service Laboratory on implementation outcomes, including contingency management Reach, Adoption, and Implementation.

Specific Aim 2: To test the effectiveness of the Science of Service Laboratory on patient outcomes, including: Stimulant Abstinence and Treatment Retention.

Eligibility criteria: * Opioid Treatment Program Counselors:

  * Inclusion criteria: 1) provide ongoing psychosocial support to medication for opioid use disorder patients (e.g., intake sessions, individual counseling, and/or group counseling sessions), and 2) have an active caseload
  * Exclusion criteria: Younger than 18 years of age, unable to provide informed consent
* Persons on Medication for Opioid Use Disorder \[Not recruited, via electronic medical records only\]

  * Inclusion criteria: must be newly initiated on medication for opioid use disorders (within the past 30 days) and have concurrent stimulant use (indicated by self-report of past 30-day stimulant use or positive toxicology screen within 30 days).
  * Exclusion criteria: Younger than 18 years of age, Does not have electronic medical records

Primary outcomes:
measure: Change in percent of patients receiving contingency management from pre-implementation to post-implementation
timeFrame: 10 months
measure: Change in percent of counselors delivering contingency management from pre-implementation to post-implementation
timeFrame: 10 months
Secondary outcomes:
measure: Change in the percent of toxicology screens negative for stimulants
timeFrame: 10 months
measure: Change in number of contingency management sessions
timeFrame: 10 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lawndale Christian Health Center
state: Illinois
city: Chicago
country: United States
facility: Healthcare Alternative Systems NEXA-MAR
state: Illinois
city: Chicago
country: United States
facility: Community Outreach Intervention Projects Southside Mobile Van
state: Illinois
city: Chicago
country: United States
facility: Family Guidance Centers Chicago Ave.
state: Illinois
city: Pawtucket
country: United States
facility: Addiction Recovery Institute
state: Rhode Island
city: Pawtucket
country: United States
facility: CODAC Pawtucket
state: Rhode Island
city: Providence
country: United States
facility: Providence Comprehensive Treatment Center
state: Rhode Island
city: Providence
country: United States
facility: VICTA
state: Rhode Island
city: Providence
country: United States
facility: CODAC Providence
state: Rhode Island
city: Woonsocket
country: United States
facility: Woonsocket Comprehensive Treatment Center
state: Rhode Island
Study officials:
affiliation: Northwestern University
name: Sara Becker
role: PRINCIPAL_INVESTIGATOR
References: