Smoking Cessation Program for Quitting Smoking

(ANBL-I Trial)

Overseen By Joseph Pacheco, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lehigh University

Disqualifiers: Non-American Indian, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

576 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a smoking cessation program called All Nations Breath of Life, which combines group and individual counseling specifically designed for American Indian communities. Participants may choose to use medication to aid in quitting, though it is not required. The program suits self-identified American Indians who smoke at least one cigarette a day and wish to quit. Participants should be willing to commit for six months and must have a home address and phone number. As an unphased trial, this study provides a unique opportunity for participants to contribute to culturally tailored health solutions.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that the All Nations Breath of Life program is safe?

Research has shown that the All Nations Breath of Life (ANBL) program is a smoking cessation method designed to respect and incorporate different cultures. It offers both group and individual counseling and has been tested in various communities. Although earlier studies did not specifically examine safety, they demonstrated that the program could help people quit smoking.

Participants may choose to use medications to aid in quitting, but this is not required. Since the program emphasizes counseling, it is generally manageable for participants. Many continue with the program, suggesting they find it acceptable.

While specific safety data is lacking, it is important to note that this program does not involve drugs. Typically, such programs carry fewer risks than new medications, making it a safer choice for those wanting to quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "All Nations Breath of Life" (ANBL) program because it offers a culturally tailored approach to smoking cessation. Unlike standard treatments like nicotine replacement therapy or medications such as varenicline and bupropion, ANBL emphasizes group-based and individual counseling, which can provide personalized support and motivation. This program also allows participants the choice to use pharmacotherapy, making it flexible and adaptable to individual needs. By integrating cultural elements into the cessation process, ANBL aims to enhance engagement and effectiveness, potentially addressing gaps left by conventional methods.

What evidence suggests that the All Nations Breath of Life program is effective for smoking cessation?

Research has shown that the All Nations Breath of Life (ANBL) program, the focus of this trial, can help people quit smoking. One study found that participants in the ANBL program were about twice as likely to stop smoking after six months compared to those in another program. Another study reported that 20.1% of ANBL participants quit smoking after six months. The program shows particular promise for American Indians, who often have high smoking rates. ANBL includes both group and individual counseling and may offer optional medication support. ^{1 2 6 7 8}

Who Is on the Research Team?

Christine M Daley, PhD

Principal Investigator

Lehigh University

Are You a Good Fit for This Trial?

This trial is for self-identified American Indians aged 18 or older who smoke at least one cigarette per day and are planning to quit. Participants must have a home address, telephone number, and be willing to participate in the program and follow-up for 6 months.

Inclusion Criteria

Willing to be followed for 6 months

Have a home address and telephone number

Willing to participate

Exclusion Criteria

Any of the above do not apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Group Support Sessions

Participants engage in group-based support sessions led by a community facilitator, including a quit date and family sessions.

12 weeks

Weekly group sessions

Individual Telephone Counseling

Facilitators conduct telephone sessions using Motivational Interviewing techniques to support participants.

12 weeks

Follow-up

Participants are monitored for smoking cessation through self-report and expired CO at 6 months.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• All Nations Breath of Life

Trial Overview The All Nations Breath of Life (ANBL) smoking cessation program is being tested across four sites—two reservation and two urban—to see how well it works outside of reservations. The study allows some flexibility for communities to adapt parts of the intervention while following core guidelines.

How Is the Trial Designed?

Group I: All Nations Breath of Life Experimental Treatment 1 Intervention

ANBL is a culturally tailored smoking cessation program that incorporates group-based and individual counseling. Participants may elect to take pharmacotherapy, but are not required to do so.

All Nations Breath of Life is already approved in United States for the following indications:

Approved in United States as All Nations Breath of Life for:

• Smoking cessation in American Indian populations

Who Is Running the Clinical Trial?

Lehigh University

Lead Sponsor

Trials

24

Recruited

6,800+

University of Kansas Medical Center

Collaborator

Trials

527

Recruited

181,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The minimal-contact smoking cessation program effectively engages smokers in both inpatient and outpatient settings by providing a brief consultation and a self-help kit, which includes exercises and a stop-smoking contract.

The program encourages compliance through weekly follow-up calls and incentives, such as lottery tickets, making it adaptable for various health care settings and practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A minimal-contact smoking cessation program in a health care setting. Strecher, VJ.[2018]

A consensus among eight nursing experts led to the selection of two key outcomes for evaluating patients during smoking cessation: Smoking Cessation Behavior and Substance Withdrawal Severity, each with specific indicators.

The development of operational definitions for these outcomes will enable standardized evaluations, improving the quality of care for patients trying to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing Outcomes for the Evaluation of Patients During Smoking Cessation. Monteiro Mantovani, V., Rodríguez Acelas, AL., Lucena, AF., et al.[2018]

In a study involving 21 patients in a smoking cessation support group, significant improvements were observed in Smoking Cessation Behavior and Substance Withdrawal Severity over time, indicating effective behavioral change.

The use of Nursing Outcomes Classification (NOC) outcomes provided valuable insights into the clinical progress of patients, emphasizing the importance of monitoring withdrawal symptoms and behavioral changes during smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Patients in a Smoking Cessation Support Group Using the Nursing Outcomes Classification. Monteiro Mantovani, V., Rodríguez Acelas, AL., Klockner Boaz, S., et al.[2020]

In a study of 157 smokers, the nicotine nasal solution (NNS) significantly improved smoking cessation rates compared to placebo, with abstinence rates of 51% at 6 weeks and 29% at 6 months for the NNS group versus 24% and 18% for the placebo group.

While the NNS group maintained higher abstinence rates at 1 year (25% vs 17%) and 2 years (19% vs 14%), these differences were not statistically significant, indicating that while NNS is effective in the short term, its long-term impact may require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind randomized trial of nicotine nasal spray as an aid in smoking cessation. Blöndal, T., Franzon, M., Westin, A.[2019]

In a study of 39 participants using the American Lung Association's 'Freedom from Smoking' program, 31% successfully remained cigarette-free for one year, indicating a notable efficacy of the intervention.

The results suggest that nicotine gum is most effective when used for abrupt cessation rather than tapering off, providing a low-cost strategy to enhance smoking cessation success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking intervention: combination therapy using nicotine chewing gum and the American Lung Association's "Freedom from Smoking" manuals. Daughton, DM., Kass, I., Fix, AJ., et al.[2019]

The smoking reduction and cessation program for nurses showed significant improvements in smoking practices after 8 weeks, including a decrease in the number of nurses who continued to smoke and a reduction in the mean number of cigarettes smoked.

Long-term assessment of the program's effectiveness was challenging due to participant attrition and varying quitting patterns, indicating that while initial results were promising, sustaining smoking cessation in nurses remains complex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smoking reduction and cessation program with registered nurses: findings and implications for community health nursing. Chalmers, K., Bramadat, IJ., Cantin, B., et al.[2019]

In a study involving 446 smokers, a 15-mg nicotine patch combined with minimal behavioral support led to a 12-month smoking cessation success rate of 16%, significantly higher than the 6% success rate with a placebo patch.

The study suggests that implementing a low-resource smoking cessation program with nicotine patches can effectively double the success rate compared to placebo, making it a viable option for lung clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation with four nicotine replacement regimes in a lung clinic. Tønnesen, P., Mikkelsen, KL.[2019]

A new nicotine nasal spray (NNS) significantly improved smoking cessation success rates compared to a placebo in a study of 255 smokers, with continuous abstinence rates showing marked differences at various intervals (e.g., 63% vs. 40% on day 5).

The NNS was found to be safe and well-tolerated, providing a faster-acting alternative to traditional nicotine replacement therapies, with side effects being common but manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a nicotine nasal spray in smoking cessation: a placebo-controlled, double-blind trial. Schneider, NG., Olmstead, R., Mody, FV., 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]

In a study of 270 heavy nicotine-dependent smokers undergoing a 3-week inpatient smoking cessation program, 42.6% successfully remained nonsmokers after 12 months, demonstrating that even heavy smokers can benefit significantly from such interventions.

Successful quitters reported a significant reduction in nicotine cravings and withdrawal symptoms, suggesting that fears of intense cravings may be unfounded, although weight gain was a common side effect that needs to be managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inpatient smoking cessation therapy: truth or dare? Boehm, G., Schroeder, Y., Schoberberger, R.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5067178/

All Nations Breath of Life: A Randomized Trial of Smoking ... The culturally tailored smoking-cessation program ANBL may or may not be an effective program in promoting cessation at 12 weeks and 6 months. Participants in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3061617/

All Nations Breath Of Life: Using Community-Based ... The program shows promise for improving quit rates among American Indians, who have the highest smoking rates and lowest quit rates of any ethnic group.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379716301933

All Nations Breath of Life: A Randomized Trial of Smoking ... There was a statistically significant difference in self-reported 6-month intent-to-treat point prevalence abstinence rates between ANBL (20.1%) and CBP (12.0%) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04931810

Urban and Reservation Implementation of All Nations ... ANBL is a culturally tailored smoking cessation program that incorporates group-based and individual counseling. Participants may elect to take pharmacotherapy, ...

5. researchgate.net researchgate.net/publication/305415163_All_Nations_Breath_of_Life

(PDF) All Nations Breath of Life Participants in the culturally tailored ANBL program were approximately twice as likely to quit smoking at 6 months compared with the CBP ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5892857/

Feasibility of Implementing the All Nations Breath of Life ... This is the first large feasibility study of a culturally tailored smoking cessation program for American Indians with good cessation and retention rates in a ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01106456

NCT01106456 | Smoking Cessation for American Indians We have begun to address these issues through the creation of the "All Nations Breath of Life" (ANBL) smoking cessation program using community-based ...

8. withpower.com withpower.com/trial/phase-3-2021-68d35

Smoking Cessation Program for Quitting Smoking (ANBL-I Trial) The ANBL-I medical study, being run by Lehigh University, is evaluating whether All Nations Breath of Life will have tolerable side effects & efficacy for ...