An interventional study of Practice Companion in Substance Use, Substance-Related Disorders and Adolescent Substance Use, sponsored by Massachusetts General Hospital. Not yet recruiting at 5 sites in 2 countries. Open to participants aged 14 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research
Substance use, including the use of opioids, cannabis, and other drugs, is common among adolescents and young adults, and overdose has become a leading cause of death among youth in Canada and the United States. Many young people who use substances also experience co-occurring mental health concerns. Evidence-based approaches to youth substance use care exist, including overdose prevention and safety strategies (such as naloxone) and medications for addiction treatment. These approaches remain adult-oriented, however, unevenly implemented in youth-serving settings, and insufficiently centered on the needs and goals of youth and their families.
This study develops and pilot tests a written "practice companion" that helps clinicians and other trusted adults provide developmentally appropriate substance use care to youth ages 14 to 24 in hospital and community settings. The practice companion offers practical, easy-to-use guidance organized by substance and by pattern of use. It addresses cannabis and other substances that youth commonly use and that clinicians frequently seek support with, alongside a strong focus on overdose prevention through its core elements: naloxone, other safety strategies, overdose prevention and safety education, and medications for opioid use disorder. It also attends to co-occurring mental health needs and to how poverty, housing instability, and other social circumstances shape substance use and access to care.
The research team will first interview youth who use substances, their families and caregivers, and clinicians to learn how each element of care should be adapted for young people. The team will then produce the practice companion and pilot test it with 60 youth across three sites, in British Columbia, Québec, and Massachusetts. After receiving care guided by the practice companion, youth will complete an interview about whether the care was relevant, useful, appropriate, and acceptable. Families and clinicians will also be interviewed to assess how feasible, sustainable, and faithful to its design the practice companion is in practice.
Throughout the study, the team will work closely with youth and families who have lived experience through a community-based participatory research approach that includes Community Advisory Boards. Findings will guide a larger future study of the practice companion's effectiveness.
Background and rationale. Substance use, including the use of opioids, cannabis, and other drugs, is common among youth, and overdose has become a leading cause of death among adolescents and young adults in Canada and the United States. Most youth overdose deaths involve illicitly manufactured fentanyl, and the illicit drug supply is increasingly contaminated with benzodiazepines, xylazine, and other novel substances. Approximately two-thirds of youth with a substance use disorder also experience co-occurring mental health concerns. Evidence-based approaches to youth substance use care, including safety and overdose prevention interventions (naloxone, other safety strategies, and behavioral approaches) and medications for opioid use disorder (MOUD), remain adult-oriented, unevenly implemented in pediatric and youth-serving settings, and insufficiently centered on the needs and goals of youth and their families. Youth experiencing poverty and housing instability face additional barriers to care.
Objective. This three-year, community-engaged project adapts evidence-based substance use care and overdose prevention approaches to the developmental needs of youth and combines them into a single, practical, multi-strategy practice companion for clinicians and other trusted adults working in acute (e.g., hospital) and community (e.g., drop-in clinic) settings. Practice companion content is organized by substance and by pattern of use and addresses cannabis and other substances that youth commonly use, in addition to opioids; overdose prevention remains a core component. The practice companion also attends to co-occurring mental health needs and to how poverty and housing instability shape substance use and access to care. The work lays the groundwork for a larger hybrid effectiveness-implementation study of the practice companion.
Conceptual framework. The project follows the ADAPT-ITT implementation science framework, focusing on the Adaptation, Production, and Testing phases, and uses a community-based participatory research approach that engages youth and their families and caregivers at every stage. Youth and caregivers with lived experience contribute throughout via three Community Advisory Boards (one at each of the three sites).
Pilot testing. Trained clinicians and other providers deliver care via the practice companion to 60 youth (20 per site). After receiving care, youth complete a qualitative exit interview and a brief quantitative survey assessing acceptability. Interviews with 30 caregivers (10 per site) and the 12 practice companion-delivering providers further assess feasibility, sustainability, and fidelity. Plan-Do-Study-Act cycles guide continuous optimization, producing final site-specific versions of the practice companion for a future, larger study.
Sites and settings. British Columbia: BC Children's Hospital and Foundry (a provincial network of integrated youth services centres). Québec: CHU Sainte-Justine (including its Substance Use and Addiction Program) and the CRCHUM. Massachusetts: the Adolescent and Young Adult Clinic at Mass General Brigham for Children.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 60 is below the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Youth ages 14 to 24 who use substances receive developmentally appropriate substance use care from a clinician (or other trained provider) using the practice companion. Depending on individual needs, the provider offers guidance across the practice companion's elements, including overdose prevention (naloxone, other safety strategies, overdose prevention and safety education, and medications for addiction treatment), support around cannabis and other substance use, and attention to co-occurring mental health, delivered through non-stigmatizing, youth- and family-centered scripts and referral guidance.
Behavioral: Practice Companion
A written, multi-strategy practice companion that guides clinicians and other trusted adults in acute and community settings to deliver developmentally appropriate substance use care to youth. Content is organized by substance and by pattern of use. It includes scripts for initiating non-stigmatizing conversations and guidance and referrals for connecting youth and families to care, spanning cannabis and other substance use, overdose prevention as a core component (naloxone, other safety strategies, overdose prevention and safety education, and medications for opioid use disorder), and co-occurring mental health needs. The practice companion is youth- and family-centered and attends to how poverty and housing instability shape substance use and access to care. Site-specific adaptations are provided for the British Columbia, Québec, and Massachusetts settings.
Mean Score on the Experience of Care and Health Outcomes (ECHO) Survey
Youth-reported acceptability of care received via the practice companion, measured with the ECHO Survey, a validated patient-reported experience measure, administered after receipt of practice companion-based care.
Time frame: Within 1 to 2 weeks after receipt of practice companion-based care
Number of Youth Reporting the Practice Companion as Acceptable, Relevant, Useful, and Appropriate
Themes on the relevance, usefulness, appropriateness, and overall acceptability of practice companion content and delivery, derived from semi-structured qualitative exit interviews with youth following receipt of care via the practice companion.
Time frame: Within 1 to 2 weeks after receipt of practice companion-based care
Number of Providers and Caregivers Reporting the Practice Companion as Feasible to Deliver
Themes on the feasibility of delivering the practice companion in acute and community care settings, from qualitative interviews with caregivers and practice companion-delivering clinicians.
Time frame: Through completion of pilot testing (approximately 18 months)
Number of Providers Reporting the Practice Companion as Sustainable to Deliver
Themes on the sustainability of practice companion delivery, from qualitative interviews with clinicians and Community Advisory Board input.
Time frame: Through completion of pilot testing (approximately 18 months)
Percentage of Practice Companion Fidelity Checklist Items Delivered as Intended
Fidelity of practice companion delivery, assessed by intervention-delivering clinicians using a standardized fidelity checklist reviewed at 3-to-4-month intervals.
Time frame: Through completion of pilot testing (approximately 18 months)
Number of Substance Use Days Reported on the Timeline Follow-Back Interview
Self-reported substance use patterns measured with the Timeline Follow-Back interview.
Time frame: Baseline (at the pilot-test visit)
Number of Participants Reporting an Overdose in the Past 3 Months
Self-reported overdose experiences in the past 3 months.
Time frame: Baseline (at the pilot-test visit)
Plan to share: Yes — De-identified individual participant quantitative data (e.g., survey and Timeline Follow-Back data) will be shared. Qualitative interview transcripts will not be shared, given the risk of re-identification within this small population of youth who use substances.
Supporting information: Study protocol, Informed consent form
Time frame: Beginning after overall study completion, with no fixed end date.
Access criteria: Open access. The de-identified quantitative dataset and supporting documents will be posted in a publicly accessible data repository.
Start is estimated for Jan 2027; primary completion for Dec 2029, 35 months later.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 35 months is close to that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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