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
About this trial
This is an interventional treatment trial for Tobacco Use Disorder
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.
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
NCT ID
NCT03626064
First Posted
June 11, 2018
Last Updated
March 28, 2023
Sponsor
Ottawa Hospital Research Institute
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
Learn more about this trial
The PROMPT Pilot Study
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