Smoking Cessation Programs for Quitting Smoking

Overseen By Dana Carroll, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Masonic Cancer Center, University of Minnesota

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

416 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital program designed to help American Indian individuals quit smoking. The researchers aim to determine if a culturally tailored texting program, the Cultural Smoking Cessation Program, is more effective than a standard one. Participants will be randomly assigned to receive either the standard program or the tailored one. This trial suits American Indian individuals who smoke at least three cigarettes a day, are considering quitting, and have daily access to a smartphone or tablet for messaging. As an unphased trial, it offers a unique opportunity to contribute to culturally relevant research and potentially benefit from a tailored smoking cessation program.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this program is safe for participants?

Research has shown that text-based programs to help people quit smoking are generally safe and well-liked. One study found that a 12-week program using text messages effectively supported smoking cessation. Participants reported it was easy to use and caused no major side effects.

Another review examined programs tailored to different cultural needs. These programs also produced positive results in helping people quit smoking, with no significant safety issues.

Studies indicate that people find text messages helpful and not harmful for quitting smoking. This suggests that the cultural smoking cessation program under testing is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smoking Cessation Programs trial because it explores innovative texting strategies to help people quit smoking. Unlike traditional smoking cessation options like nicotine replacement therapies or prescription medications, this trial compares a standard texting program to a culturally tailored one. The tailored program is specifically designed to resonate with individual cultural backgrounds, potentially making it more engaging and effective. By leveraging personalized communication, this approach could offer a fresh, relatable tool to support smokers on their journey to quit.

What evidence suggests that this trial's treatments could be effective for quitting smoking?

Research shows that smoking cessation programs tailored to cultural needs can be effective. A review of studies found that these programs often help people quit or reduce smoking. In this trial, participants will join different treatment arms. One arm will receive a tailored texting program, which previous research indicates works better than standard ones. Another arm will receive a standard texting program. Some research indicates that American Indian adults who used culturally tailored programs were more likely to remain smoke-free. These findings suggest that adapting smoking cessation efforts to cultural needs and using personalized messages may improve the chances of quitting successfully. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for American Indian adults who smoke at least 3 cigarettes daily, are considering quitting, and have access to a smartphone or tablet. They must be over 18 years old and able to read and speak English.

Inclusion Criteria

I identify as American Indian based on my own understanding.

I have smoked at least 3 cigarettes daily in the last month.

I use a smartphone or tablet daily that can send messages.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a culturally aligned digital smoking cessation resource via a remotely conducted randomized controlled trial

6 months

Remote interactions

Follow-up

Participants are monitored for smoking cessation outcomes, including quit attempts and abstinence, at 1, 3, and 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cultural Smoking Cessation Program

Trial Overview The study tests a digital smoking cessation program tailored for American Indians against a standard program. Participants will be randomly assigned to one of the two programs in this remote-controlled trial.

How Is the Trial Designed?

Group I: Tailored Active Control 1 Intervention

Tailored texting program for quit smoking

Group II: Standard Placebo Group 1 Intervention

Standard texting program for quit smoking

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Smoking cessation counseling provided by physicians and trained health professionals can lead to abstinence rates between 2.1% and 17.4%, indicating some effectiveness in helping people quit smoking.

However, the overall clinical effect of smoking cessation counseling is considered low, and long-term cessation rates remain uncertain, suggesting a need for further cost-effectiveness analyses before widespread implementation in public health programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Counseling interventions for smoking cessation: systematic review]. Alba, LH., Murillo, R., Castillo, JS.[2019]

The All Nations Snuff Out Smokeless (ANSOS) program was developed specifically for American Indians, who have the highest rates of smokeless tobacco use in the U.S., and showed a 68.8% retention rate with 33 out of 48 participants completing the program.

Among those who completed the program, 34% reported being abstinent from smokeless tobacco, and when accounting for those lost to follow-up, the overall cessation rate was 22.9%, indicating that the program may be effective and culturally appropriate for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Testing All Nations Snuff Out Smokeless (ANSOS): A Culturally Tailored Smokeless Tobacco Cessation Program for American Indians. Daley, CM., Lewis, C., Nazir, N., et al.[2022]

Proactive referral by healthcare staff significantly increases enrollment rates in behavioral smoking cessation programs, particularly benefiting low-income smokers, as shown in a systematic review of 34 studies.

E-referral systems are more effective and acceptable for implementing proactive referrals compared to traditional fax systems, suggesting that they could enhance access to smoking cessation resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proactive Referral to Behavioral Smoking Cessation Programs by Healthcare Staff: A Systematic Review. van Westen-Lagerweij, NA., Hipple Walters, BJ., Potyka, F., et al.[2023]

A hospital-based smoking cessation program that included behavioral counseling and support was effective, achieving a 32% abstinence rate at 12 months among participants who attended at least two sessions.

Factors such as self-belief in quitting, having a heart condition, and not growing up with smoking siblings were linked to higher chances of long-term abstinence, highlighting the importance of social and psychological influences in quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of hospital-based smoking cessation. Fung, PR., Snape-Jenkinson, SL., Godfrey, MT., et al.[2019]

In a study of 270 heavy nicotine-dependent smokers undergoing a three-week inpatient smoking cessation program, 42.6% were verified as ex-smokers 12 months later, indicating a significant success rate for long-term cessation.

Ex-smokers reported notable improvements in lifestyle satisfaction compared to those who continued smoking, suggesting that the program not only aids in quitting but also enhances overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heavy dependent nicotine smokers--Newfound lifestyle appreciation after quitting successfully. Experiences from inpatient smoking cessation therapy. Schoberberger, R., Böhm, G., Schroeder, Y.[2018]

Computer-based smoking cessation programs are effective and can be delivered on a large scale at a low cost, making them accessible to many smokers.

These programs work best when combined with pharmacotherapy and can serve as a helpful addition to counseling provided by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using new information technology to treat tobacco dependence. Etter, JF.[2017]

The 'All Nations Breath of Life' (ANBL) program is being tested as a culturally-tailored smoking cessation intervention specifically for American Indian smokers, with a total of 448 participants involved in the trial.

This study is significant as it is the first controlled trial to evaluate the effectiveness of a culturally-specific approach to smoking cessation in a population with a high smoking prevalence, aiming to address the urgent health crisis among American Indians and Alaska Natives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culturally-tailored smoking cessation for American Indians: study protocol for a randomized controlled trial. Choi, WS., Faseru, B., Beebe, LA., et al.[2021]

Citations

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Culturally-tailored text-messaging intervention for smoking ... It is the first study to examine a culturally-tailored text-message smoking cessation intervention in AI populations. In addition, by partnering ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.16400

Effectiveness of culturally tailoring smoking cessation ... This systematic review measured the effectiveness of culturally tailoring smoking cessation interventions on quitting or reducing smoking combustible tobacco.

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JAMA Publishes New Study on Proven Effectiveness of ... First-of-its-kind randomized clinical trial shows teens 35% more likely to quit vaping nicotine with an interactive, tailored text message program.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211335521002308

Effects of culturally tailored smoking prevention and ... There is some evidence that culturally tailored cessation programs can increase smoking abstinence among AI adults (Choi et al., 2016), although other research ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2801838

Assessment of a Text Message–Based Smoking Cessation ... In this study, the behavior change theory–based smoking cessation intervention using personalized text messages was more effective than an intervention using ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6571033/

Proactive text messaging (GetReady2Quit) and nicotine ... This pilot assesses text messaging plus NRT, as a proactively offered intervention for smoking cessation support in smokers receiving primary care.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714418306165

A text message delivered smoking cessation intervention The goal of this study is to test the efficacy of TMQ; a 12 week, evidence-based, tailored smoking-cessation intervention delivered 100% through text messaging.

8. researchprotocols.org researchprotocols.org/2022/12/e42553/

A Text-Based Smoking Cessation Intervention for Sexual ... The aim of this study is to develop SmokefreeSGM, a text-based smoking cessation program tailored to and tested among SGM smokers.

9. mhealth.jmir.org mhealth.jmir.org/2017/8/e116/

Feasibility and Acceptability of a Text Message-Based ... This preliminary data show that a SMS text message cognitive behavioral smoking cessation program can be implemented and should be ...