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NCT Number: NCT03626064

The PROMPT Pilot Study

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.

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Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Substance-Related Disorders Tobacco Dependence Tobacco Use Cessation

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smoking cessation counselling

Behavioral

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

Nicotine Replacement Therapy

Drug

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

Primary outcomes

  1. Retention of Study Participants

    Time frame: 6 months

    Retention rate at 6-month follow-up

Secondary outcomes

  1. Biochemical Validation of Smoking Cessation Outcome

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 10, 2018
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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