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Substance UseNCT07725289

Clinician Practice Companion to Address Youth Substance Use

A study testing Practice Companion in people with Substance Use and Substance-Related Disorders, run by Massachusetts General Hospital at 5 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 14 to 24 yearsHealthy volunteers can take part
What is being tested?
Practice Companion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
5 sitesin 2 countries
Study dates
Jan 2027to Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Ages 14 to 24 years.
  • Uses drugs or alcohol (past year).
  • Receiving care at a participating study site.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Danya Fast, PhD contact

604-875-2345

danya.fast@ubc.ca

Scott E Hadland, MD, MPH, MS contact

617-724-3873

shadland@mgh.harvard.edu

5 sites in 2 countries

Canada4 sites
  • Centre de Recherche du CHUM (CRCHUM)

    Montreal, Quebec, H2X 0A9

    514-890-8000

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

    514-345-4931

  • BC Children's Hospital

    Vancouver, British Columbia, V6H 3N1

    604-875-2345

  • Foundry (Foundry Central Office)

    Vancouver, British Columbia

    info@foundrybc.ca

Other trials in Canada

United States1 site
  • Adolescent and Young Adult Medicine, Mass General Brigham for Children

    Boston, Massachusetts, 02114

    617-643-1201

Other trials in United States

About this study

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.

Read more

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.

Read the detailed description

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.

Being tested
Practice Companion
Keywords
Adolescents, Young adults, Youth, Substance use, Substance use care, Cannabis, Naloxone, Fentanyl, Medications for opioid use disorder (MOUD), Buprenorphine, Methadone, Overdose prevention, Co-occurring mental health, Youth- and family-centred care, Patient-reported outcomes, Implementation science, ADAPT-ITT, Community-based participatory research, Toolkit
Medical subject headings
Substance-Related Disorders, Opioid-Related Disorders, Drug Overdose, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Practice CompanionBehavioural

    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.

Study groups in NCT07725289
Study groupRoleWhat they receive
Practice CompanionExperimentalYouth 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.
Receives: Behavioral: Practice Companion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 1 to 2 weeks after receipt of practice companion-based care

  2. 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.

    Measured: Within 1 to 2 weeks after receipt of practice companion-based care

Secondary outcomes (3)
  1. 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.

    Measured: Through completion of pilot testing (approximately 18 months)

  2. 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.

    Measured: Through completion of pilot testing (approximately 18 months)

  3. 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.

    Measured: Through completion of pilot testing (approximately 18 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
All pilot-test participants receive care via the single practice companion intervention; there is no comparison or control arm.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07725289
Sponsor's protocol ID
2024p003521
Other IDs
R34DA062280, PJT-205890
Status last verified
Oct 2026
First submitted
20 Jul 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Daniels AS, Shaul JA, Greenberg P, Cleary PD. The Experience of Care and Health Outcomes Survey (ECHO): A Consumer Survey to Collect Ratings of Behavioral Health Care Treatment, Outcomes and Plans. In: Maruish ME, ed. The Use of Psychological Testing for Treatment Planning and Outcomes Assessment, Volume 3: Instruments for Adults. 3rd ed. Mahwah, NJ: Lawrence Erlbaum Associates; 2004.

  • Fast D. Going Nowhere: Ambivalence about Drug Treatment during an Overdose Public Health Emergency in Vancouver. Med Anthropol Q. 2021 Jun;35(2):209-225. doi: 10.1111/maq.12638. Epub 2021 Apr 18.

    PubMed 33866590
  • Hadland SE, Burr WH, Zoucha K, Somberg CA, Camenga DR. Treating Adolescent Opioid Use Disorder in Primary Care. JAMA Pediatr. 2024 Apr 1;178(4):414-416. doi: 10.1001/jamapediatrics.2023.6493.

    PubMed 38407892
  • Hadland SE, Bagley SM, Rodean J, Silverstein M, Levy S, Larochelle MR, Samet JH, Zima BT. Receipt of Timely Addiction Treatment and Association of Early Medication Treatment With Retention in Care Among Youths With Opioid Use Disorder. JAMA Pediatr. 2018 Nov 1;172(11):1029-1037. doi: 10.1001/jamapediatrics.2018.2143.

    PubMed 30208470
  • Hadland SE, Wood E, Levy S. How the paediatric workforce can address the opioid crisis. Lancet. 2016 Sep 24;388(10051):1260-1. doi: 10.1016/S0140-6736(16)31573-2. No abstract available.

    PubMed 27673455
  • Larochelle MR, Bernson D, Land T, Stopka TJ, Wang N, Xuan Z, Bagley SM, Liebschutz JM, Walley AY. Medication for Opioid Use Disorder After Nonfatal Opioid Overdose and Association With Mortality: A Cohort Study. Ann Intern Med. 2018 Aug 7;169(3):137-145. doi: 10.7326/M17-3107. Epub 2018 Jun 19.

    PubMed 29913516
  • Friedman J, Godvin M, Shover CL, Gone JP, Hansen H, Schriger DL. Trends in Drug Overdose Deaths Among US Adolescents, January 2010 to June 2021. JAMA. 2022 Apr 12;327(14):1398-1400. doi: 10.1001/jama.2022.2847.

    PubMed 35412573
  • Hjorthoj CR, Hjorthoj AR, Nordentoft M. Validity of Timeline Follow-Back for self-reported use of cannabis and other illicit substances--systematic review and meta-analysis. Addict Behav. 2012 Mar;37(3):225-33. doi: 10.1016/j.addbeh.2011.11.025. Epub 2011 Nov 26.

    PubMed 22143002
  • Raymond-King C, Jeffery MM, Melnick ER. Current Causes of Death among Children and Adolescents in the United States. N Engl J Med. 2026 May 14;394(19):1958-1959. doi: 10.1056/NEJMc2600445. No abstract available.

    PubMed 42127398
  • Wingood GM, DiClemente RJ. The ADAPT-ITT model: a novel method of adapting evidence-based HIV Interventions. J Acquir Immune Defic Syndr. 2008 Mar 1;47 Suppl 1:S40-6. doi: 10.1097/QAI.0b013e3181605df1.

    PubMed 18301133

Questions about this trial

What is this clinical trial studying?

A study testing Practice Companion in people with Substance Use and Substance-Related Disorders, run by Massachusetts General Hospital at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Danya Fast, PhD (604-875-2345, danya.fast@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Score on the Experience of Care and Health Outcomes (ECHO) Survey (time frame: Within 1 to 2 weeks after receipt of practice companion-based care). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07725289, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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