NCT03194958

Helping Poor Smokers Quit

Completed NA Results posted Last updated 26 December 2023

What this trial tests

NA trial testing Specialized Quitline in Smoking Cessation in 1,944 participants. Completed in 1 July 2022.

Timeline

5 June 2017

Primary endpoint
1 July 2022

1 July 2022

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	health services research
Enrollment	1,944
Start date	5 June 2017
Primary completion	1 July 2022
Estimated completion	1 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Specialized Quitline
• Basic Needs Navigator

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →
• Smoking, Tobacco — all drugs for Smoking, Tobacco →
• Smoking, Cigarette — all drugs for Smoking, Cigarette →
• Smoking, Pipe — all drugs for Smoking, Pipe →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Smoking Cessation or Smoking, Tobacco. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Abstinence 6-months Primary · 6 months post-baseline

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

Group	Value	95% CI
Standard Quitline	101
Specialized Quitline	90
Standard Quitline With Basic Needs Navigator	74
Specialized Quitline With Basic Needs Navigator	103

Abstinence 3-months Secondary · 3 months post-baseline

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

Group	Value	95% CI
Standard Quitline	97
Specialized Quitline	104
Standard Quitline With Basic Needs Navigator	80
Specialized Quitline With Basic Needs Navigator	105

24hr Quit Attempt Secondary · 6 months post-baseline

Report quitting smoking for at least 24 hours during intervention

Group	Value	95% CI
Standard Quitline	241
Specialized Quitline	219
Standard Quitline With Basic Needs Navigator	248
Specialized Quitline With Basic Needs Navigator	235

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Telephone counselling for smoking cessation.
   Matkin W, Ordóñez-Mena JM, Hartmann-Boyce J. · · 2019 · cited 155× · PMID 31045250 · DOI 10.1002/14651858.cd002850.pub4
2. Stress, depression, sleep problems and unmet social needs: Baseline characteristics of low-income smokers in a randomized cessation trial.
   Garg R, McQueen A, Roberts C, Butler T, et al · · 2021 · cited 15× · PMID 34849423 · DOI 10.1016/j.conctc.2021.100857
3. Helping low-income smokers quit: findings from a randomized controlled trial comparing specialized quitline services with and without social needs navigation.
   Kreuter MW, Garg R, Fu Q, Caburnay C, et al · · 2023 · cited 10× · PMID 37408953 · DOI 10.1016/j.lana.2023.100529
4. Leveling the Playing Field: Mailing Pharmacotherapy to Medicaid Members Who Smoke.
   McQueen A, Wartts JG, Garg R, Carpenter KM, et al · · 2023 · cited 1× · PMID 36335079 · DOI 10.1016/j.amepre.2022.09.008
5. Examining Psychosocial Correlates of a Home Smoking Ban Among Low-income Smokers: Analysis of Social Support, Unmet Social Needs, Perceived Stress, and Depressive Symptoms.
   Thompson T, Evbuoma-Fike EI, Garg R, McQueen A, et al · · 2022 · PMID 35932354 · DOI 10.1007/s10900-022-01094-4