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The PROMPT Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626064
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Tobacco Dependence Tobacco Use Cessation Behavioral: Smoking Cessation Counselling Drug: Nicotine Replacement Therapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management and Point-of-Care for Tobacco Dependence (PROMPT): a Feasibility Mixed Methods Community-based Participatory Action Research Project in Ottawa, Canada
Actual Study Start Date : June 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking

Arm Intervention/treatment
PROMPT Participants
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
One on one smoking cessation counselling with a certified mental health nurse

Drug: Nicotine Replacement Therapy
Access to a range of nicotine replacement therapy: nicotine patch, nicotine gum, nicotine lozenge, nicotine inhaler




Primary Outcome Measures :
  1. Retention of Study Participants [ Time Frame: 6 months ]
    Retention rate at 6-month follow-up


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   Yes
Criteria

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.
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03626064    
Other Study ID Numbers: 20140333-01H
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available to researchers that contact the Principal Investigator.
Supporting Materials: Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action