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The PROMPT Pilot Study

Management and Point-of-Care for Tobacco Dependence (PROMPT): a Feasibility Mixed Methods Community-based Participatory Action Research Project in Ottawa, Canada

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03626064
Enrollment
80
Registered
2018-08-10
Start date
2014-06-30
Completion date
2017-03-31
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Disorder, Tobacco Dependence, Tobacco Use Cessation

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.

Interventions

One on one smoking cessation counselling with a certified mental health nurse

DRUGNicotine Replacement Therapy

Access to a range of nicotine replacement therapy: nicotine patch, nicotine gum, nicotine lozenge, nicotine inhaler

Sponsors

Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Retention of Study Participants6 monthsRetention rate at 6-month follow-up

Secondary

MeasureTime frameDescription
Biochemical Validation of Smoking Cessation Outcome6 monthsBiochemically validated 7-day point prevalence smoking abstinence at 26 weeks, self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤10 ppm.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026