Skip to main content
OpenTrials
Completed

NCT Number: NCT03194958

Helping Poor Smokers Quit

Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri to compare the relative and combined effects of these two strategies for augmenting an existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will receive standard Missouri quitline services and half will receive new Specialized Quitline services targeted to this group. In each of these groups, half also will receive calls from a trained navigator to help them address unmet Basic Needs and the accompanying psychological distress that act as barriers to smoking cessation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Smoking Cessation Behavior Behavior, Addictive Chemically-Induced Disorders Cigarette Smoking Compulsive Behavior Health Behavior Impulsive Behavior Mental Disorders Nicotine Dependence Nicotine Dependence Tobacco Product Nicotine Dependence, Cigarettes Nicotine Use Disorder Pipe Smoking Smoking Smoking (Tobacco) Addiction Smoking, Cigarette Smoking, Pipe Smoking, Tobacco Substance-Related Disorders Tobacco Dependence Tobacco Smoking Tobacco Use Tobacco Use Cessation Tobacco Use Disorder Tobacco; Use, Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

About this study

2-1-1 information specialists will deliver standard service, then ask a random number of callers per day if they would be willing to answer a few health questions as part of a new 2-1-1 service. Callers eligible to receive the invitation to screen for study eligibility will be: Missouri residents, calling for themselves, English-speaking, and not in acute crisis. Eligible smokers will then be asked if they are willing to share their contact information with a research team conducting a study to help smokers quit. Smokers who agree to share their contact information will be considered "enrolled". Trained 2-1-1 operators will record all recruitment screening data in a secure electronic database that is shared with research staff. Research staff will attempt to reach enrolled smokers by phone by the next business day.

Alere, through the Missouri Tobacco Quitline, will provide quitline services to smokers in all study conditions. Contact information and study group assignment for smokers will be provided to Alere via secure data transfer.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years and older
  • Missouri resident
  • English speaking
  • Not in crisis
  • Smoke cigarettes every day of the week
  • Planning to quit smoking in the next 30 days
  • Comfortable receiving calls from smoking expert and project team
  • Willing to provide phone numbers to be reached

Exclusion criteria

  • Pregnant or planning to become pregnant in the next 3 months
  • Currently breastfeeding
  • Insurance through employer
  • Currently enrolled in smoking quitline

Treatment and study plan

Specialized Quitline

Behavioral

Very low-income smokers are different from other smokers in important ways not always addressed by standard quitline services. The research team and Alere staff has created custom protocols, scripts, prompts and other content to maximize intervention relevance and acceptability to very low-income smokers. Research Implementation Unit (RIU) coaches who will be delivering the Specialized Quitline services have received training from clinical quitline staff, the research team and 2-1-1 staff who have extensive experience with the target population. Focus areas for training and distinctive content and protocol for the Specialized Quitline include: health literacy, abstract vs. concrete language, lived experience, resource constraints, future orientation, getting cigarettes, living situation, phone/internet access.

Basic Needs Navigator

Behavioral

Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly.

Primary outcomes

  1. Abstinence 6-months

    Time frame: 6 months post-baseline

    Report 7-day point prevalence abstinence measured at 6-months post --baseline

Secondary outcomes

  1. Abstinence 3-months

    Time frame: 3 months post-baseline

    Report 7-day point prevalence abstinence measured at 3-months post-baseline

  2. 24hr Quit Attempt

    Time frame: 6 months post-baseline

    Report quitting smoking for at least 24 hours during intervention

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Helping the Poor Quit Smoking: Specialized Quitlines and Meeting Basic Needs

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2017
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.