What side effects are associated with this type of intervention?

The Adapt2Quit trial focuses on personalized motivational text messages for smoking cessation. Known side effects of similar text messaging interventions are minimal, primarily involving potential issues with message delivery or user engagement. For other common treatments, such as nicotine replacement therapy (NRT), side effects can include skin irritation (patches), mouth or throat irritation (lozenges, gum), and nasal irritation (nasal spray). Bupropion may cause insomnia, dry mouth, and, in rare cases, seizures. Varenicline can lead to nausea, vivid dreams, and potential neuropsychiatric effects. Behavioral therapies generally have no significant side effects but require consistent engagement and support.

What prior FDA approvals exist?

The FDA has approved several treatments for tobacco smoking cessation, including pharmacotherapies like nicotine replacement therapy (NRT), bupropion, and varenicline. These treatments help reduce withdrawal symptoms and cravings. Additionally, behavioral interventions such as telephone counseling and mobile phone text messaging have been shown to be effective. Text messaging interventions, similar to the Adapt2Quit trial, provide personalized motivational support and have been found to increase smoking cessation rates. The National Cancer Institute's SmokeFreeTXT program is an example of an effective text-based intervention.

What other types of research exist?

Promising, novel alternatives to Adapt2Quit for tobacco smoking patients include: 1) Quit4baby, an interactive and intensive text messaging program specifically for pregnant women. 2) SmokefreeMOM, a national smoking cessation text-messaging program for pregnant smokers. 3) Mobile chat messaging via WhatsApp for relapse prevention, which has shown feasibility and preliminary effectiveness. 4) Tweet2Quit, a Twitter-delivered intervention that uses peer-to-peer support in small groups.

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Behavioural Intervention

Adapt2Quit Motivational System for Quitting Smoking (A2Q Trial)

N/A

Recruiting

Led By Rajani Sadasivam, PhD

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

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

Must have

English-speaking

Be older than 18 years old

Must not have

Adults unable to consent

Individuals who are not yet adults (infants, children, teenagers)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months post-randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a computer program called Adapt2Quit that sends personalized motivational texts to help socioeconomically disadvantaged smokers quit. The program uses user feedback to choose the most motivating messages.

Who is the study for?

This trial is for English-speaking adults who smoke, have had at least two clinical visits in the past year, and are socioeconomically disadvantaged. They must own a texting-enabled cell phone. Pregnant women, prisoners, those unable to consent, minors, and previous pilot study participants cannot join.

What is being tested?

The Adapt2Quit program is being tested against a control that only facilitates quitline use via text messages. The program sends motivational texts tailored to help users quit smoking based on their feedback on message effectiveness.

What are the potential side effects?

Since this trial involves motivational messaging rather than medication or medical procedures, there are no direct physical side effects associated with participation.

Eligibility Criteria

Inclusion Criteria

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

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I speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to give consent for medical procedures.

Select...

I am under the age of 18.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months post-randomization

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

Treatment Details

Study Objectives

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

Primary study objectives

Biochemical Carbon Monoxide (CO) Verification of Tobacco Cessation

Self-Reported Participant Tobacco Cessation Rate (quit rate)

Secondary study objectives

Time to First Quit Attempt

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adapt2QuitExperimental Treatment1 Intervention

These participants will receive Adapt2Quit motivational messaging and quitline facilitation messaging for 6 months.

Group II: ControlActive Control1 Intervention

These participants will receive quitline facilitation-only messaging for 6 months.

0 / 3Eligibility 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 treatments for tobacco smoking include behavioral therapies and pharmacologic interventions. Personalized motivational text messages, like those studied in the Adapt2Quit trial, provide real-time support and encouragement, helping individuals resist cravings and stay motivated. Pharmacologic treatments, such as nicotine replacement therapy (NRT), varenicline, and bupropion, reduce withdrawal symptoms and cravings, making it easier to quit. Combining these approaches is often more effective, as behavioral support addresses psychological addiction while pharmacologic treatments manage physical dependence. This comprehensive approach is crucial for improving quit rates among smokers.

Combination treatment for nicotine dependence: state of the science.