NCT04391192

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

1 month

First QC Date

April 28, 2020

Last Update Submit

May 21, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Usage

    Number of times participants call the phone line

    3 months

Secondary Outcomes (2)

  • EMS response time

    3 months

  • EMS dispatch outcome

    3 months

Other Outcomes (4)

  • Length of calls

    3 months

  • Proportion of calls for which EMS is dispatched

    3 months

  • Timing of calls

    3 months

  • +1 more other outcomes

Study Arms (1)

Participants

EXPERIMENTAL

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

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

Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Undetermined

Calgary, Alberta, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Katherine Rittenbach, PhD

    Alberta Health services

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Feasibility of using a phone line to provide overdose response.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 18, 2020

Study Start

September 1, 2020

Primary Completion

October 1, 2020

Study Completion

February 1, 2021

Last Updated

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

There are no plans to share IPD

Locations