The PROMPT Pilot Study

Tobacco Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626064
• Other study ID #: 20140333-01H
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: March 2017

Study information

• Verified date: August 2018
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Cessation
• Tobacco Use Disorder

Intervention

Behavioral:
• Smoking Cessation Counselling
One on one smoking cessation counselling with a certified mental health nurse

Drug:
• Nicotine Replacement Therapy
Access to a range of nicotine replacement therapy: nicotine patch, nicotine gum, nicotine lozenge, nicotine inhaler

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention of Study Participants	Retention rate at 6-month follow-up	6 months
Secondary	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.	6 months