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 tests the ANBL program, a quit-smoking plan for American Indian communities. It includes group meetings led by community members, phone support, educational materials with cultural elements, and optional medications. The goal is to help participants quit smoking through community support and personal counseling. The ANBL program was created by the American Indian Health Research and Education Alliance (AIHREA) to address the high smoking rates among American Indians.

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.

How does the All Nations Breath of Life treatment differ from other smoking cessation treatments?

The All Nations Breath of Life treatment is unique because it is culturally tailored to Indigenous populations, incorporating traditional practices and community support, which is not a focus of standard nicotine replacement therapies like patches or nasal sprays. ^{1 2 3 4 5}

What data supports the effectiveness of the All Nations Breath of Life Smoking Cessation Program treatment?

Research shows that even heavy smokers can benefit from structured smoking cessation programs, as seen in studies where inpatient therapy helped smokers quit successfully. Additionally, programs involving healthcare professionals, like nurses, have shown significant changes in smoking habits, suggesting that structured support can be effective in helping people quit smoking. ^{6 7 8 9 10}

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

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]

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]

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 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 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]

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]

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 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]

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 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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Heavy dependent nicotine smokers--Newfound lifestyle appreciation after quitting successfully. Experiences from inpatient smoking cessation therapy. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Nursing Outcomes for the Evaluation of Patients During Smoking Cessation. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

A smoking reduction and cessation program with registered nurses: findings and implications for community health nursing. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Patients in a Smoking Cessation Support Group Using the Nursing Outcomes Classification. [2020]

5. Austria pubmed.ncbi.nlm.nih.gov

Inpatient smoking cessation therapy: truth or dare? [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Smoking intervention: combination therapy using nicotine chewing gum and the American Lung Association's "Freedom from Smoking" manuals. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A double-blind randomized trial of nicotine nasal spray as an aid in smoking cessation. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Smoking cessation with four nicotine replacement regimes in a lung clinic. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Efficacy of a nicotine nasal spray in smoking cessation: a placebo-controlled, double-blind trial. [2019]