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Phase 1 Completed N=49 Randomized Double-blind Prevention

Website Smoking Cessation Intervention for the Promotion of Smoking Cessation in Low-Income Veterans

Cigarette Smoking-Related Carcinoma
Source: ClinicalTrials.gov NCT04502524 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Satisfaction With Assigned Treatment — 0; 1; 17; 18 Participants — p=.999

Summary

This phase I trial studies how well a new electronic (e)-health smoking cessation program (called Vet Flexiquit) works in promoting smoking cessation in low-income veterans who may or may not be ready to quit smoking. The study will compare the new website smoking cessation program to the current standard care website smoking cessation program offered by the Veterans Administration (VA). Both website interventions will be accompanied by a text messaging program that includes: (1) motivational messages, and (2) reminders to use the assigned program. Both of the website interventions can help smokers quit or cut back on how much they smoke, thus dramatically reducing their chances of developing tobacco-related health conditions.

Outcome Measures

OutcomeResultp-value
PRIMARY
Satisfaction With Assigned Treatment		 0; 1; 17; 18 .999
PRIMARY
Number of Server-recorded Logins to Assigned Website		 3.7; 3.2 0.852
PRIMARY
Duration of Website Use (Days Since First Login)		 18.7; 26.7 0.451
SECONDARY
Number of Quit Attempts		 1.7; 3.2 0.508
SECONDARY
Cotinine-confirmed, Self-reported Abstinence From Smoking		 3; 3 0.941
SECONDARY
Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy)		 2; 3 0.612
SECONDARY
Change in Readiness to Quit		 -0.4; -0.5 0.504
SECONDARY
Change in Acceptance of Smoking Triggers		 0.4; 0.3 0.670

Eligibility Criteria

Inclusion Criteria

  • Participants must be a US veteran
  • Participants must be low-income, as defined by falling below Veterans Health Administration (VHA) national income threshold for no-cost healthcare
  • Participants must be a current smoker, averaging at least 5 cigarettes/day for the last 30 days
  • Participants must have weekly internet access for the next 3 months
  • Participants must self-report current use of a personal email address to receive the link to their assigned web site
  • Participants must self-report being willing to complete all study activities
  • Participants must be willing to receive study-related text messages

Exclusion Criteria

  • Currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program
  • Have recent (past 30 days) substance use disorder, suicidal ideation, or psychiatric hospitalization
  • Previous participation in the treatment development stage of the new smoking cessation website program
  • Prior use of the SmokefreeVET web site
  • Member of the same household as another research participant
  • Woman who is pregnant or breastfeeding, or planning to become pregnant
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04502524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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