Drug OverdoseNCT04391192
Virtual Overdose Response
A study testing Virtual Overdose Response in people with Drug Overdose, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Overdose
- What is being tested?
- Virtual Overdose Response
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2020to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Drug Overdose
- Being tested
- Virtual Overdose Response
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Overdose ResponseBehavioural
All participants will be provided the phone number and encouraged to call when they use alone.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | All participants will be given the phone number and encouraged to call any time they plan to use substances alone Receives: Behavioral: Virtual Overdose Response |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage
Number of times participants call the phone line
Measured: 3 months
Secondary outcomes (2)
EMS response time
Amount of time from calling 911 to EMS arriving on scene
Measured: 3 months
EMS dispatch outcome
qualitative description of dispatch outcome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study startSep 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: Sponsor determined that it must be terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility of using a phone line to provide overdose response.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, AHS Addiction and Mental Health Strategic Clinical Network, TELUS
- Responsible party
- Sponsor
- Investigators
- Katherine Rittenbach, PhD, Principal investigator, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391192
- Sponsor's protocol ID
- AMH-SCN-05
- Status last verified
- May 2021
- First submitted
- 28 Apr 2020
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share IPD
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
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Overdose Response
- ClinicalTrials.gov ID
- NCT04391192
- Acronym / sponsor ID
- AMH-SCN-05
- Conditions
- Drug Overdose
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor determined that it must be terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, AHS Addiction and Mental Health Strategic Clinical Network, TELUS
- Study start
- Sep 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility of using a phone line to provide overdose response.
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Behavioral: Virtual Overdose ResponseAll participants will be given the phone number and encouraged to call any time they plan to use substances alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Overdose ResponseAll participants will be provided the phone number and encouraged to call when they use alone. | Behavioural | Participants |
Primary outcome
Usage
Time frame: 3 months
Number of times participants call the phone line
2 secondary outcomes
EMS response time
Time frame: 3 months
EMS dispatch outcome
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Derived from this study: PubMed 33978598Bristowe 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.
- Individual participant dataSharing planned: No. There are no plans to share IPD
Related trials for Drug Overdose
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Drug-Related Side Effects and Adverse Reaction, Digoxin Overdose
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PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
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RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Rittenbach, PhD principal investigator
Alberta Health services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Overdose Response in people with Drug Overdose, run by AHS Cancer Control Alberta at 1 site in Canada.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage (time frame: 3 months). 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 NCT04391192, which also lists 1 linked publication.
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 25 May 2021.