The PROMPT Pilot Study

O

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)

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems