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The PROMPT Pilot Study

Primary Purpose

Tobacco Use Disorder, Tobacco Dependence, Tobacco Use Cessation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smoking Cessation Counselling
Nicotine Replacement Therapy
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • currently living in Ottawa for at least 3 months prior to enrolment
  • 16 years or older
  • have used drugs in the past year (excluding marijuana and alcohol)
  • have smoked tobacco in the past 7 days

Exclusion Criteria:

  • consent declined (refusal from participant or decision maker)
  • any person accessing addictions treatment (in-patient drug rehabilitation) and hence unavailable for follow-up
  • any person currently or recently (in the past 30 days) enrolled in a smoking cessation program
  • anyone with a terminal illness with a life expectancy of <3 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    PROMPT Participants

    Arm Description

    80 participants who are homeless or at-risk for homelessness, smoke tobacco, and identify as People Who Use Drugs in Ottawa.

    Outcomes

    Primary Outcome Measures

    Retention of Study Participants
    Retention rate at 6-month follow-up

    Secondary Outcome Measures

    Biochemical Validation of Smoking Cessation Outcome
    Biochemically validated 7-day point prevalence smoking abstinence at 26 weeks, self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤10 ppm.

    Full Information

    First Posted
    June 11, 2018
    Last Updated
    March 28, 2023
    Sponsor
    Ottawa Hospital Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03626064
    Brief Title
    The PROMPT Pilot Study
    Official Title
    Management and Point-of-Care for Tobacco Dependence (PROMPT): a Feasibility Mixed Methods Community-based Participatory Action Research Project in Ottawa, Canada
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The PROMPT Pilot Study is a feasibility mixed methods prospective cohort study following principles of community-based participatory action research. The study recruited 80 people who use drugs and followed them for 6 months while providing access to counselling, nicotine replacement therapy and peer-support in a community setting. A notable reduction in average cigarette use per day (20.5 to 9.3) and illicit substance use (18.8%) was observed at study-end. PROMPT's patient engagement model is an effective harm-reduction strategy for the growing opioid use crisis and can improve the health outcomes of marginalised at-risk populations worldwide.
    Detailed Description
    Objective To determine the feasibility of a Community-Based Participatory Tobacco Dependence Strategy (PROMPT) in the inner city population of Ottawa (Canada). Design A feasibility mixed methods prospective cohort study following principles of community-based participatory action research. Intervention Recruited 80 people who use drugs, followed them for 6 months while providing access to counseling, nicotine replacement therapy and peer-support in a community setting. Setting Community research office in downtown Ottawa, adjacent to low-income housing, shelter services and street-based drug consumption. Primary outcome Retention rate at 6-month follow-up. Secondary outcome Biochemically validated 7-day point prevalence smoking abstinence at 26 weeks, self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤10 ppm.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tobacco Use Disorder, Tobacco Dependence, Tobacco Use Cessation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PROMPT Participants
    Arm Type
    Other
    Arm Description
    80 participants who are homeless or at-risk for homelessness, smoke tobacco, and identify as People Who Use Drugs in Ottawa.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Smoking Cessation Counselling
    Intervention Description
    One on one smoking cessation counselling with a certified mental health nurse
    Intervention Type
    Drug
    Intervention Name(s)
    Nicotine Replacement Therapy
    Intervention Description
    Access to a range of nicotine replacement therapy: nicotine patch, nicotine gum, nicotine lozenge, nicotine inhaler
    Primary Outcome Measure Information:
    Title
    Retention of Study Participants
    Description
    Retention rate at 6-month follow-up
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Biochemical Validation of Smoking Cessation Outcome
    Description
    Biochemically validated 7-day point prevalence smoking abstinence at 26 weeks, self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤10 ppm.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: currently living in Ottawa for at least 3 months prior to enrolment 16 years or older have used drugs in the past year (excluding marijuana and alcohol) have smoked tobacco in the past 7 days Exclusion Criteria: consent declined (refusal from participant or decision maker) any person accessing addictions treatment (in-patient drug rehabilitation) and hence unavailable for follow-up any person currently or recently (in the past 30 days) enrolled in a smoking cessation program anyone with a terminal illness with a life expectancy of <3 months.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be available to researchers that contact the Principal Investigator.
    IPD Sharing Time Frame
    Data will be available upon request for the period decided necessary by the Principal Investigator and the inquiring researcher or researchers.
    IPD Sharing Access Criteria
    Will provide access in the manner decided by Principal Investigator and the inquiring researcher or researchers.
    Citations:
    PubMed Identifier
    35710334
    Citation
    Pakhale S, Visentin C, Tariq S, Kaur T, Florence K, Bignell T, Jama S, Huynh N, Boyd R, Haddad J, Alvarez GG. Lung disease burden assessment by oscillometry in a systematically disadvantaged urban population experiencing homelessness or at-risk for homelessness in Ottawa, Canada from a prospective observational study. BMC Pulm Med. 2022 Jun 16;22(1):235. doi: 10.1186/s12890-022-02030-x.
    Results Reference
    derived
    PubMed Identifier
    33478466
    Citation
    Pakhale S, Tariq S, Huynh N, Jama S, Kaur T, Charron C, Florence K, Nur F, Bustamante-Bawagan ME, Bignell T, Boyd R, Haddad J, Kendzerska T, Alvarez G. Prevalence and burden of obstructive lung disease in the urban poor population of Ottawa, Canada: a community-based mixed-method, observational study. BMC Public Health. 2021 Jan 21;21(1):183. doi: 10.1186/s12889-021-10209-w.
    Results Reference
    derived

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    The PROMPT Pilot Study

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