The PROMPT Pilot Study

NCT ID: NCT03626064

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Tobacco Use Disorder Tobacco Dependence Tobacco Use Cessation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PROMPT Participants

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

Group Type OTHER

Smoking Cessation Counselling

Intervention Type BEHAVIORAL

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

Nicotine Replacement Therapy

Intervention Type DRUG

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

Interventions

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Smoking Cessation Counselling

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

Intervention Type BEHAVIORAL

Nicotine Replacement Therapy

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Pakhale S, Visentin C, Tariq S, Kaur T, Florence K, Bignell T, Jama S, Huynh N, Boyd R, Haddad J, Alvarez GG. Lung disease burden assessment by oscillometry in a systematically disadvantaged urban population experiencing homelessness or at-risk for homelessness in Ottawa, Canada from a prospective observational study. BMC Pulm Med. 2022 Jun 16;22(1):235. doi: 10.1186/s12890-022-02030-x.

Reference Type DERIVED
PMID: 35710334 (View on PubMed)

Pakhale S, Tariq S, Huynh N, Jama S, Kaur T, Charron C, Florence K, Nur F, Bustamante-Bawagan ME, Bignell T, Boyd R, Haddad J, Kendzerska T, Alvarez G. Prevalence and burden of obstructive lung disease in the urban poor population of Ottawa, Canada: a community-based mixed-method, observational study. BMC Public Health. 2021 Jan 21;21(1):183. doi: 10.1186/s12889-021-10209-w.

Reference Type DERIVED
PMID: 33478466 (View on PubMed)

Other Identifiers

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20140333-01H

Identifier Type: -

Identifier Source: org_study_id

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