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WithdrawnNCT04391192Updated May 25, 2021

Virtual Overdose Response

An interventional study of Virtual Overdose Response in Drug Overdose, sponsored by AHS Cancer Control Alberta. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-25.

Sponsored by AHS Cancer Control Alberta · Not applicable, Interventional, and Other

Why this study was withdrawn
Sponsor determined that it must be terminated
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

To help prevent deaths in populations that cannot or will not access physical safer consumption services in Alberta, which may disproportionately include women and those who are not able to self-inject (Potier et al., 2014) the investigators propose to provide virtual (phone-based) supervised consumption services, staffed by people with lived experience.

Read the detailed description

Designed as a small open label clinical study to demonstrate proof of concept which will follow CONSORT guidelines, the investigators aim to recruit approximately 15 people who are currently using illicit substances and who currently use opioids (illicit or prescription - non-medically). The sample size of 15 balances pragmatic issues (difficulty in recruiting people who are actively using illicit substances) and the need to have a good sample of the population. These participants will be interviewed by the research coordinator in person prior to intervention initiation to determine baseline use; history of overdose; and current harm reduction activities (see appendix). They will then be asked to call the intervention number if they are going to be using alone (see appendix for call flow).

Each time a participant dials the number, the operator will gather (as part of the intervention) the address the participant is at, their name/pseudonym and a phone number that can be used as a call back number in case the call is disconnected. The phone line operator will then ask a) what they planned on using, b) the method of use, c) if the participant is using safe sterile supplies (and provide information on where they can get new supplies in their community), and d) if they have a naloxone kit (overdose reversal kit) available. They will then inform the participant that they will be checking in on them every 5 - 10 minutes and if they do not respond, they will call emergency medical services for them.

If the participant responds to each verbal prompt (calling their name) over a minimum of 30 minutes, the operator will let them know that they are disconnecting the call. The operator will offer to connect the participant to other health services, such as the location of new supplies, social services, addiction treatment and opioid agonist therapy. If the participant fails to respond to a prompt (or the call is disconnected and is not able to be reconnected), the operator will contact the dispatch supervisor and the process for emergency services dispatch will be initiated.

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Conditions studied

  • Drug Overdose

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03

In context

Drug Overdose

139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.

Browse Drug Overdose studies →

Lead sponsor

AHS Cancer Control Alberta is the lead sponsor of 182 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Able to give informed consent - able to speak and understand English and over 18 years of age
  • Admit to using opioids non-medically: using illicit opioids; using prescription opioids without a current prescription; using doses greater than those prescribed; using opioids recreationally
  • Have access to a phone line in the location they primarily use opioids: this can be a land line or a cell phone
  • Resident of Calgary

Exclusion criteria

Exclusion Criteria:

  • Unable to give informed consent - unable to understand English, under 18 years of age or otherwise not legally able
  • Do not knowingly use opioids non-medically
  • No access to a phone
  • Live outside of Calgary
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Participants

    All participants will be given the phone number and encouraged to call any time they plan to use substances alone

    Behavioral: Virtual Overdose Response

Interventions

  • BehavioralVirtual Overdose Response

    All participants will be provided the phone number and encouraged to call when they use alone.

06

What researchers measure

Primary outcomes

  1. Usage

    Number of times participants call the phone line

    Time frame: 3 months

Secondary outcomes

  1. EMS response time

    Amount of time from calling 911 to EMS arriving on scene

    Time frame: 3 months

  2. EMS dispatch outcome

    qualitative description of dispatch outcome

    Time frame: 3 months

Other outcomes

  1. Length of calls

    overall time required for a single call to the service

    Time frame: 3 months

  2. Proportion of calls for which EMS is dispatched

    quantitative analysis of the number of times the operator calls 911 for a participant

    Time frame: 3 months

  3. Timing of calls

    Analysis of what time of day most calls come in to the service

    Time frame: 3 months

  4. Health care usage

    analysis of overall health system usage (based on administrative data) by the participants

    Time frame: 3 months

07

Study locations

1 site
  • Undetermined
    Calgary, Alberta, Canada
08

References and documents

Publications

  • Bristowe SK, Ghosh SM, Trew M; Canadian Mental Health Association - Calgary Region; Rittenbach K. Virtual Overdose Response for People Who Use Opioids Alone: Protocol for a Feasibility and Clinical Trial Study. JMIR Res Protoc. 2021 May 12;10(5):e20183. doi: 10.2196/20183. PubMed 33978598 ↗

Individual participant data

Plan to share: No — There are no plans to share IPD

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04391192
Lead sponsor
AHS Cancer Control Alberta
Collaborators
Alberta Innovates Health Solutions, AHS Addiction and Mental Health Strategic Clinical Network, TELUS
Responsible party
Sponsor
First posted
May 18, 2020
Start date
Sep 2020 (estimated)
Primary completion
Oct 2020 (estimated)
Completion
Feb 2021 (estimated)
Last update
May 25, 2021

Study contacts

Katherine Rittenbach, PhD
principal investigator · Alberta Health services

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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