The PROMPT Pilot Study

Not Applicable

Completed

• Conditions: Tobacco Dependence; Tobacco Use Disorder; Tobacco Use Cessation
• Interventions: Behavioral: Smoking Cessation Counselling; Drug: Nicotine Replacement Therapy

• Registration Number: NCT03626064
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Study First Submitted: 2018-06-11
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-10
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PROMPT Participants	Smoking Cessation Counselling	80 participants who are homeless or at-risk for homelessness, smoke tobacco, and identify as People Who Use Drugs in Ottawa.
PROMPT Participants	Nicotine Replacement Therapy	80 participants who are homeless or at-risk for homelessness, smoke tobacco, and identify as People Who Use Drugs in Ottawa.

Primary Outcome Measures

Name	Time	Method
Retention of Study Participants	6 months	Retention rate at 6-month follow-up

Secondary Outcome Measures

Name	Time	Method
Biochemical Validation of Smoking Cessation Outcome	6 months	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.