The PROMPT Pilot Study

Ottawa Hospital Research Institute

Status: Completed

Conditions: Tobacco Dependence; Tobacco Use Cessation; Tobacco Use Disorder

Treatments: Behavioral: Smoking Cessation Counselling; Drug: Nicotine Replacement Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03626064

20140333-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

PROMPT Participants

Other group

Description:

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

Treatment:

Drug: Nicotine Replacement Therapy

Behavioral: Smoking Cessation Counselling