| Registry | NCT07725289 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, health services research |
| Enrollment | 60 (Estimated) |
| Sponsor | Massachusetts General Hospital (Other); collaborators: National Institute on Drug Abuse (NIDA), University of British Columbia, Boston Medical Center, Centre Hospitalier Universitaire Sainte-Justine (CHU-SJ) (University of Montreal), Université de Montréal |
| Conditions | Substance Use, Substance-Related Disorders, Adolescent Substance Use, Cannabis Use, Opioid Use Disorder, Drug Overdose, Overdose Prevention, Co-occurring Mental Health Conditions |
| Interventions | Practice Companion (Behavioral) |
| Dates | start 2027-01-01 (estimated), primary completion 2029-12-01 (estimated), completion 2029-12-01 (estimated), first posted 2026-07-24, last updated 2026-10-07 |
| Locations | 5 sites in United States, Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Substance Use All trials for Substance-Related Disorders All trials of Practice Companion
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Practice Companion | Experimental | Behavioral: Practice Companion | 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. |
Sex: All, ages: 14 Years to 24 Years, accepts healthy volunteers
Inclusion Criteria: * Ages 14 to 24 years. * Uses drugs or alcohol (past year). * Receiving care at a participating study site. Exclusion Criteria: * Cognitive limitations or intellectual disabilities that prevent provision of informed consent. * Any medical or psychiatric condition causing acute distress or requiring emergency evaluation. * Current membership on a study Community Advisory Board.
| Facility | City | Country | Status |
|---|---|---|---|
| Adolescent and Young Adult Medicine, Mass General Brigham for Children | Boston, Massachusetts | United States | |
| BC Children's Hospital | Vancouver, British Columbia | Canada | |
| Foundry (Foundry Central Office) | Vancouver, British Columbia | Canada | |
| Centre de Recherche du CHUM (CRCHUM) | Montreal, Quebec | Canada | |
| CHU Sainte-Justine | Montreal, Quebec | Canada |
NIH grants: R34DA062280