NCT05702021

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 cohort of public sector addiction specialty treatment programs will be randomized to receive Science of Service Laboratory across four cohorts. Each of the programs will provide de-identified electronic medical record data from all available patient charts on contingency management delivery and patient outcomes. Staff from each 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jun 2023Aug 2027

First Submitted

Initial submission to the registry

January 11, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 7, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

January 11, 2023

Last Update Submit

April 27, 2026

Conditions

Keywords

StimulantsContingency managementOpioid Use DisorderImplementation scienceBehavior change

Outcome Measures

Primary Outcomes (2)

  • Change in percent of patients receiving contingency management from pre-implementation to post-implementation

    This is an implementation outcome capturing Reach and is extracted from electronic medical records. This is a patient-level measure of the change in the percent of newly inducted patients with a history of stimulant use who are documented as having received 1 or more contingency management sessions from pre-implementation to post-implementation.

    10 months

  • Change in percent of counselors delivering contingency management from pre-implementation to post-implementation

    This is an implementation outcome capturing Adoption and is extracted from electronic medical records. This is a provider-level measure of the change in percent of counselors at each program who are documented as having delivered 1 or more contingency management sessions from pre-implementation to post-implementation.

    10 months

Secondary Outcomes (2)

  • Change in the percent of toxicology screens negative for stimulants

    10 months

  • Change in number of contingency management sessions

    10 months

Study Arms (2)

Science of Service Laboratory implementation strategy

EXPERIMENTAL

The Science of Service Laboratory implementation strategy consists of: didactic training (contingency management workshops; monthly contingency management coaching calls), performance feedback (practice sessions and electronic medical record feedback); and facilitation (monthly facilitation calls).

Behavioral: Science to Service Laboratory

Stepped wedge comparator

NO INTERVENTION

Our hybrid trial uses a unidirectional crossover stepped wedge design. All sites cross over in the same direction from usual care to intervention. All sites therefore act as their own comparison prior to the sequential roll-out of the implementation strategy.

Interventions

The Science of Service Laboratory implementation strategy consists of: didactic training (contingency management workshops; monthly contingency management coaching calls), performance feedback (practice sessions and electronic medical record feedback); and facilitation (monthly facilitation calls).

Science of Service Laboratory implementation strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Persons on Medication for Opioid Use Disorder \[Not recruited, via electronic medical records only\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

ACCESS Community Health Networks

Chicago, Illinois, 60609, United States

RECRUITING

Lawndale Christian Health Center

Chicago, Illinois, 60623, United States

COMPLETED

Healthcare Alternative Systems

Chicago, Illinois, 60651, United States

COMPLETED

Community Outreach Intervention Projects

Chicago, Illinois, 60654, United States

RECRUITING

Family Guidance Centers

Chicago, Illinois, 60654, United States

RECRUITING

Rosecrance Health Network

Rockford, Illinois, 61108, United States

RECRUITING

Addiction Recovery Institute

Pawtucket, Rhode Island, 02860, United States

COMPLETED

Comprehensive Treatment Centers

Providence, Rhode Island, 02905, United States

COMPLETED

CODAC

Providence, Rhode Island, 02909, United States

COMPLETED

Related Publications (1)

  • Becker SJ, DiClemente-Bosco K, Scott K, Janssen T, Salino SM, Hasan FN, Yap KR, Garner BR. Implementing contingency management for stimulant use in opioid treatment programs: protocol of a type III hybrid effectiveness-stepped-wedge trial. Implement Sci. 2023 Sep 13;18(1):41. doi: 10.1186/s13012-023-01297-w.

MeSH Terms

Conditions

DiseaseOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Sara Becker

    Northwestern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kira DiClemente-Bosco

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes will be exported from electronic medical records. Data analysts will not know who was receiving the intervention at what time point.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Stepped-wedge trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Alice Hamilton Professor of Psychiatry

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 27, 2023

Study Start

June 7, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

This study protocol is embedded within a Center of Excellence funded by the National Institute on Drug Abuse. In coordination with other center project components, the study protocol and statistical analysis plan for primary outcomes will be submitted for publication to either an addiction (e.g., Addiction, Journal of Substance Abuse Treatment) or implementation science (e.g., Implementation Science, Implementation Science: Research and Practice) journal. Additional data (analytic code, participant-level data) can be requested from the Principal Investigator. Analysis files will be constructed from the electronic data and will be stripped of identifying information. Specifically, participants will be identified with a numeric identifier that is not related to any element of their personal identifying information. No names, addresses, telephone numbers, email addresses, medical record numbers, etc. will be retained in the de-identified files.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Protocol will be submitted for publication in coordination with other project components, with a target submission date in 2023. Analytic code and participant-level data will be made ready for distribution within 12 months of study completion.
Access Criteria
Data will only be shared with external investigators when a data use agreement (DUA) is executed between Northwestern University and the requester's institution. The DUA will specify the requested data elements (each of which must be justified), the specific research question, the timeline for the project, and schedule for data destruction.

Locations