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Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults

Primary Purpose

Nicotine Dependence, Cigarettes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web + text smoking cessation intervention
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence, Cigarettes focused on measuring smoking, smoking cessation, nicotine, nicotine dependence

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Vermont

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Web + text smoking cessation intervention

Usual care control

Arm Description

Participants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention

Participants will receive referral to a quit smoking hotline

Outcomes

Primary Outcome Measures

30-day point prevalence smoking abstinence
Self-reported smoking abstinence and biochemical validation (saliva cotinine)
Self-efficacy to quit smoking
Confidence to quit within the next month (7days) on 0-10 scale
Intervention engagement
Completing 75% or more of 12 weekly check-ins

Secondary Outcome Measures

7-day point prevalence smoking abstinence
Self-reported smoking abstinence
Number of 24-hour quit attempts
Number of times intentionally stopped smoking cigarettes for 24 hours or longer because trying to quit
Perceived support to quit smoking
4 items pertaining to quit support from the text messages
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

Full Information

First Posted
April 24, 2020
Last Updated
February 8, 2021
Sponsor
University of Vermont
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT04379388
Brief Title
Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults
Official Title
Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 21, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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: Providing consent to participate in the study; Confirming contact information; Completing a payment acknowledgement form that allows us to reimburse for survey/task completions; and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Cigarettes
Keywords
smoking, smoking cessation, nicotine, nicotine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
437 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web + text smoking cessation intervention
Arm Type
Experimental
Arm Description
Participants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention
Arm Title
Usual care control
Arm Type
No Intervention
Arm Description
Participants will receive referral to a quit smoking hotline
Intervention Type
Behavioral
Intervention Name(s)
Web + text smoking cessation intervention
Intervention Description
Participants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention
Primary Outcome Measure Information:
Title
30-day point prevalence smoking abstinence
Description
Self-reported smoking abstinence and biochemical validation (saliva cotinine)
Time Frame
Assessed at 3-month follow-up
Title
Self-efficacy to quit smoking
Description
Confidence to quit within the next month (7days) on 0-10 scale
Time Frame
Assessed at 3-month follow-up
Title
Intervention engagement
Description
Completing 75% or more of 12 weekly check-ins
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
7-day point prevalence smoking abstinence
Description
Self-reported smoking abstinence
Time Frame
Assessed at 3-month follow-up
Title
Number of 24-hour quit attempts
Description
Number of times intentionally stopped smoking cigarettes for 24 hours or longer because trying to quit
Time Frame
Assessed at 3-month follow-up
Title
Perceived support to quit smoking
Description
4 items pertaining to quit support from the text messages
Time Frame
Assessed 3-month follow-up
Title
Pattern and rate of tobacco/e-cigarette use
Description
Past 30 (90 day) use of tobacco or nicotine products such as cigars, e-cigarettes, chewing tobacco, and nicotine replacement products
Time Frame
Assessed at 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea C Villanti, PhD, MPH
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults

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