NCT04379388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
437

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

April 24, 2020

Last Update Submit

February 8, 2021

Conditions

Keywords

smokingsmoking cessationnicotinenicotine dependence

Outcome Measures

Primary Outcomes (3)

  • 30-day point prevalence smoking abstinence

    Self-reported smoking abstinence and biochemical validation (saliva cotinine)

    Assessed at 3-month follow-up

  • Self-efficacy to quit smoking

    Confidence to quit within the next month (7days) on 0-10 scale

    Assessed at 3-month follow-up

  • Intervention engagement

    Completing 75% or more of 12 weekly check-ins

    12 weeks

Secondary Outcomes (4)

  • 7-day point prevalence smoking abstinence

    Assessed at 3-month follow-up

  • Number of 24-hour quit attempts

    Assessed at 3-month follow-up

  • Perceived support to quit smoking

    Assessed 3-month follow-up

  • Pattern and rate of tobacco/e-cigarette use

    Assessed at 3-month follow-up

Study Arms (2)

Web + text smoking cessation intervention

EXPERIMENTAL

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

Behavioral: Web + text smoking cessation intervention

Usual care control

NO INTERVENTION

Participants will receive referral to a quit smoking hotline

Interventions

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

Web + text smoking cessation intervention

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmokingSmoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorHealth Behavior

Study Officials

  • Andrea C Villanti, PhD, MPH

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 24, 2020

First Posted

May 7, 2020

Study Start

April 21, 2020

Primary Completion

October 1, 2020

Study Completion

October 15, 2020

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations