Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults

Nicotine Dependence, Cigarettes Clinical Trial

Official title:

Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379388
• Other study ID #: 17-0351
• Secondary ID: P20GM103644
• Status: Completed
• Phase: N/A
• Start date: April 21, 2020
• Est. completion date: October 15, 2020

Study information

• Verified date: February 2021
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to understand how to develop and deliver a better smoking cessation program for lower-income young adult smokers.

Description:

Using content and strategy developed from the formative research phase, this randomized smoking cessation trial will test the impact of a tailored cessation intervention for socioeconomically-disadvantaged young adult (SDYA) smokers compared to a usual-care control on intervention engagement, self-efficacy to quit, and 30-day point prevalence abstinence at 3-month follow-up.

This study will take place over a 3-month period. Individuals who complete the screening survey and are eligible to participate will be asked to complete a 15-20 minute baseline survey at the start of the study. This survey will ask questions about use of mobile phones, tobacco use, recent alcohol and other drug use, concerns about the coronavirus outbreak and how it may affect personal tobacco use, and physical activity. After the first survey, participants will be assigned randomly to one of two study groups:

Group A: Referral to a quit smoking hotline (quit line)

Group B: Referral to a quit smoking hotline (quit line), plus enrollment in a web and text-based smoking cessation intervention.

Participants in both groups will be enrolled after completing the following steps, in order:

1. Providing consent to participate in the study;

2. Confirming contact information;

3. Completing a payment acknowledgement form that allows us to reimburse for survey/task completions; and

4. Completing the baseline survey.

To complete enrollment, participants in Group B will also be required to register for an account on BecomeAnEx.org and enroll in text messages on the site. Once registered, Group B participants will be enrolled in a text message program customized for this study and will need to respond to the initial message from the text message platform to initiate text messages.

Participants in Group B will receive daily text messages for 3 months with content delivered through the Truth Initiative's BecomeAnEx digital quit smoking platform. They will also receive brief (1-2 minute) weekly check-in surveys related to the week's messages and smoking status during this time.

At 3-months, participants in both groups will receive the 15-minute follow-up assessment. Participants in both groups who report quitting smoking at 3-months will be mailed a kit in order to take a saliva test to measure the amount of cotinine, a metabolite of nicotine, in their saliva. Participants who report smoking at the 3-month follow-up will not receive this saliva test.

All study procedures will take place remotely, with surveys conducted online. Participants in Group A will be paid at least $30 for participation and up to $80. Participants in Group B will be paid at least $40 for participation and up to $170.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: October 15, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• age 18-30

• lives in the U.S.

• smoked at least 100 lifetime cigarettes

• currently smokes every day or some days

• interest in quitting smoking within the next 6 months

• subjective financial situation of just meeting or not meeting basic expenses

• access to a smartphone with internet

Related Conditions & MeSH terms

• Nicotine Dependence, Cigarettes
• Tobacco Use Disorder

Intervention

Behavioral:
• Web + text smoking cessation intervention
Participants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day point prevalence smoking abstinence	Self-reported smoking abstinence and biochemical validation (saliva cotinine)	Assessed at 3-month follow-up
Primary	Self-efficacy to quit smoking	Confidence to quit within the next month (7days) on 0-10 scale	Assessed at 3-month follow-up
Primary	Intervention engagement	Completing 75% or more of 12 weekly check-ins	12 weeks
Secondary	7-day point prevalence smoking abstinence	Self-reported smoking abstinence	Assessed at 3-month follow-up
Secondary	Number of 24-hour quit attempts	Number of times intentionally stopped smoking cigarettes for 24 hours or longer because trying to quit	Assessed at 3-month follow-up
Secondary	Perceived support to quit smoking	4 items pertaining to quit support from the text messages	Assessed 3-month follow-up
Secondary	Pattern and rate of tobacco/e-cigarette use	Past 30 (90 day) use of tobacco or nicotine products such as cigars, e-cigarettes, chewing tobacco, and nicotine replacement products	Assessed at 3-month follow-up