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
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder Tobacco Dependence Tobacco Use Cessation||Behavioral: Smoking Cessation Counselling Drug: Nicotine Replacement Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Retention of Study Participants [ Time Frame: 6 months ]Retention rate at 6-month follow-up
- 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.