The PROMPT Pilot Study

NCT03626064 | Completed

• 1 other identifier: 20140333-01H
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tobacco Use Disorder; Tobacco Dependence; Tobacco Use Cessation

Outcome Measures

Primary Outcomes (1)

• Retention of Study Participants

  Retention rate at 6-month follow-up

  6 months

Secondary Outcomes (1)

• Biochemical Validation of Smoking Cessation Outcome

  6 months

Study Arms (1)

PROMPT Participants

OTHER

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

Behavioral: Smoking Cessation Counselling; Drug: Nicotine Replacement Therapy

Interventions

Smoking Cessation Counselling BEHAVIORAL

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

PROMPT Participants

Nicotine Replacement Therapy DRUG

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

PROMPT Participants

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• currently living in Ottawa for at least 3 months prior to enrolment
• years or older
• have used drugs in the past year (excluding marijuana and alcohol)
• have smoked tobacco in the past 7 days

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Related Publications (2)

• 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.

  PMID: 35710334 DERIVED

• 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.

  PMID: 33478466 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Use Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: August 10, 2018
• Study Start: June 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 29, 2023

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will be available upon request for the period decided necessary by the Principal Investigator and the inquiring researcher or researchers.
• Access Criteria: Will provide access in the manner decided by Principal Investigator and the inquiring researcher or researchers.