What side effects are associated with this type of intervention?

Behavioral support via text messaging, such as SmokefreeTXT, generally has minimal side effects, primarily involving the potential for increased screen time and possible message fatigue. Pharmacotherapy options like nicotine replacement therapy (NRT) can cause side effects such as skin irritation (patches), mouth or throat irritation (lozenges, gum), and nasal irritation (nasal spray). Bupropion may lead to insomnia, dry mouth, and, in rare cases, seizures. Varenicline can cause nausea, vivid dreams, and, less commonly, mood changes. Counseling and behavioral interventions typically have no direct physical side effects but may require significant time and emotional investment.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for smoking cessation, including varenicline, bupropion, and various forms of nicotine replacement therapies (NRTs) such as patches, lozenges, and gum. Behavioral support methods, particularly those delivered via text messaging like the SmokefreeTXT program, have also been shown to be effective in aiding smoking cessation. These text-based interventions provide continuous support and have been demonstrated to double the rates of biochemically verified abstinence at six months.

What other types of research exist?

Promising, novel alternatives to SmokefreeTXT for smoking cessation include: 1) Quit4baby, an interactive and intensive text messaging program specifically for pregnant women; 2) COach2Quit, a smartphone application that combines exhaled carbon monoxide readings with message support; 3) SmokefreeMOM, an automated text-messaging program for pregnant smokers; and 4) smartphone applications that incorporate behavior change techniques (BCTs) for a more comprehensive approach to smoking cessation.

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Behavioral Intervention

Text Messaging Program for Smoking Cessation

N/A

Waitlist Available

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 and over

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing SmokefreeTXT, a text messaging program designed to help people stop smoking. It focuses on smokers in different regions of Virginia and aims to see how well the program works by sending supportive and motivational texts. SmokefreeTXT is a mobile phone smoking cessation service developed by the National Cancer Institute, and it has been shown to be effective in several studies.

Who is the study for?

This trial is for adult smokers in Virginia who have smoked at least 100 cigarettes in their lifetime and currently smoke. They must own a cell phone, be able to read and speak English, and not be pregnant or planning pregnancy within six months. Those already attempting to quit smoking or living in an area with enough participants are excluded.

What is being tested?

The study tests SmokefreeTXT, a text messaging program designed to help people stop smoking. Participants will use the research version of this service while researchers track their progress across several regions of Virginia through assessments over a six-month period.

What are the potential side effects?

Since SmokefreeTXT is a non-medical intervention involving text messages for smoking cessation support, there are no direct medical side effects associated with its use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Self-reported continuous abstinence

Smoke

Side effects data

From 2023 Phase 4 trial • 1316 Patients • NCT03538938

Infection prompting hospitalization

Injury or poisoning

Kidney disease, or kidney or bladder infection

Stroke, seizure, aneurysm, or suspected multiple sclerosis relapse

Gastrointestinal disease, pancreatitis, ulcer, or injury (e.g., hernia)

100%

80%

60%

40%

20%

Study treatment Arm

1-Call, Patch, SmokefreeTXT, Financial Incentive

1-Call, Patch+Loz, SmokefreeTXT, Financial Incentive

1-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive

1-Call, Patch+Loz, No SmokefreeTXT, No Financial Incentive

4-Call, Patch, SmokefreeTXT, Financial Incentive

4-Call, Patch, No SmokefreeTXT, No Financial Incentive

4-Call, Patch, SmokefreeTXT, No Financial Incentive

1-Call, Patch, No SmokefreeTXT, Financial Incentive

4-Call, Patch+Loz, No SmokefreeTXT,No Financial Incentive

1-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive

4-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive

1-Call, Patch, SmokefreeTXT, No Financial Incentive

4-Call, Patch, No SmokefreeTXT, Financial Incentive

1-Call, Patch, No SmokefreeTXT, No Financial Incentive

4-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive

4-Call, Patch+Loz, SmokefreeTXT, Financial Incentive

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SmokfreeTXTExperimental Treatment1 Intervention

Research version of the publicly available SmokefreeTXT program

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SmokefreeTXT

2018

Completed Phase 4

~1490

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common smoking cessation treatments work through both behavioral and pharmacologic mechanisms. Behavioral support, such as text messaging programs like SmokefreeTXT, provides real-time encouragement, coping strategies, and reminders to help manage cravings and maintain motivation. Pharmacologic treatments, including nicotine replacement therapy (NRT) and medications like varenicline, reduce withdrawal symptoms and decrease the rewarding effects of nicotine. This combination is particularly effective because it addresses both the psychological and physical aspects of nicotine dependence, offering a comprehensive approach to quitting smoking.

Mindfulness-Based Smoking Cessation Delivered Through Telehealth and Text Messaging for Low-Income Smokers: Protocol for a Randomized Controlled Trial.The natural history of efforts to stop smoking: a prospective cohort study.Randomized controlled trial of behavioral activation smoking cessation treatment for smokers with elevated depressive symptoms.