Smoking Cessation Program for Quitting Smoking
(ANBL-I Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByChristine M Daley, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Lehigh University
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
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.
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.
12345How 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.
678910Eligibility Criteria
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
I am 18 years old or older.
Have a home address and telephone number
+4 more
Exclusion Criteria
Any of the above do not apply
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: All Nations Breath of LifeExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Lehigh UniversityBethlehem, PA
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Who Is Running the Clinical Trial?
Lehigh UniversityLead Sponsor
University of Kansas Medical CenterCollaborator
National Institute on Drug Abuse (NIDA)Collaborator
References
Heavy dependent nicotine smokers--Newfound lifestyle appreciation after quitting successfully. Experiences from inpatient smoking cessation therapy. [2018]This is an evaluation of an ongoing inpatient smoking cessation program available in Austria and aims to show to what extent even heavy nicotine dependent smokers can benefit from a three-week inpatient therapy.
Nursing Outcomes for the Evaluation of Patients During Smoking Cessation. [2018]To select outcomes of the Nursing Outcomes Classification (NOC) and develop operational definitions for their indicators in order to evaluate patients during smoking cessation.
A smoking reduction and cessation program with registered nurses: findings and implications for community health nursing. [2019]A smoking reduction and cessation program was implemented with registered nurses in 3 Canadian provinces. Nurses (n = 117) participated in either an 8-week group or self-directed program using a resource specifically designed for nurses. Questionnaires were administered prior to and at the end of the 8-week interventions and at 6 and 12 months postintervention. Statistically significant changes at 8 weeks in nurses' smoking practices were found on the number of nurses continuing to smoke, mean number of cigarettes smoked, and movement in the stage of behavioral change. Attrition and variation in patterns of quitting over the 12-month study period made assessing participants' longer term outcomes difficult. This study highlights the complexity of assisting nurses to quit smoking and of implementing and evaluating a program based on accepted community health models of practice.
Evaluation of Patients in a Smoking Cessation Support Group Using the Nursing Outcomes Classification. [2020]To evaluate patients in a smoking cessation support group using the Nursing Outcomes Classification (NOC).
Inpatient smoking cessation therapy: truth or dare? [2018]This study aims to answer the question to which extent even very heavy nicotine-dependent smokers can benefit from a 3-week inpatient smoking cessation program. A particular focus lies on analyzing the positive effects, which go above and beyond normally anticipated health benefits.
Smoking intervention: combination therapy using nicotine chewing gum and the American Lung Association's "Freedom from Smoking" manuals. [2019]The smoking cessation efficacy of a two-session group program using the American Lung Association's "Freedom from Smoking" self-help manuals, nicotine gum, and brief, repeated professional supervision was estimated in an uncontrolled clinical trial. Of the 39 participants, 12 (31%) remained cigarette free for 1 year, and 4 others (10%) had not smoked during the 3 months prior to the 1-year follow-up. Claims of cessation were verified by expired-air carbon monoxide measurement. Nearly all successful abstainers were able to achieve 48-hr cessation during their first week using the gum. This finding suggests that nicotine gum is best used to help the smoker quit abruptly, rather than as an aid in a tapering-off strategy. This study's smoking intervention program appears to provide a relatively low-cost method of improving the success rates among smokers who wish to quit.
A double-blind randomized trial of nicotine nasal spray as an aid in smoking cessation. [2019]The objective of the study was to evaluate the therapeutic efficacy of nicotine nasal solution (NNS) for smoking cessation from the stopping day up to 3 months. We also followed the participants for 2 yrs after ceasing smoking to assess what happens after stopping using NNS. In a placebo-controlled, double-blind, 2 yr prospective study, 157 smokers were given either NNS, one dose containing 1 mg of nicotine per 100 microL (n=79), or placebo (n=78). Treatment was continued for up to 1 yr. One day after quitting smoking, the average number of daily doses was 11 in the group assigned NNS and 14 in the group assigned the placebo, and after 6 weeks, 14 and 6 doses, respectively, among abstinent participants still using spray. After 3 months, 65% of the abstainers in the nicotine group were still using the NNS. The abstinence rates were 51, 39 and 29% after 6 weeks, 3 and 6 months, respectively, as compared to 24, 19 and 18% in the placebo group (p=0.0003; p=0.003; p=0.050). The proportion abstinent at the 1 yr (25 vs 17%) and 2 yr follow-ups (19 vs 14%) was higher among those assigned to the nicotine than to the placebo group, but not significantly so for the numbers used in the study. In conclusion, the use of nicotine nasal spray significantly increased the abstinence rate during the first 6 months following the quitting day.
Smoking cessation with four nicotine replacement regimes in a lung clinic. [2019]Smoking cessation is a key intervention for prevention of several lung diseases. The aim of the present study was to compare the effect of smoking cessation with nicotine replacement in a lung clinic in a low resource set-up suitable for implementation in other lung clinics. This was an open, randomized trial with 4 different nicotine replacement regimes combined with minimal behavioural support in daily routine. A total of 446 smokers (>9 cigarettes x day(-1)) were allocated to a nurse-conducted smoking cessation programme with 4 treatment arms: a 5-mg nicotine patch ("placebo"), a 15-mg nicotine patch, nicotine inhaler, and a 15-mg nicotine patch plus nicotine inhaler. Recommended use of the nicotine products were 3 months with the possibility of continuing use up to 9 months on an individual basis. Individual follow-up studies were scheduled after 2 and 6 weeks, 3, 6, 9 and 12 months. The 12-month point prevalence was 6% (5-mg patch (placebo)), 16% (15-mg patch) (p
A minimal-contact smoking cessation program in a health care setting. [2018]A minimal-contact smoking cessation program, designed for use in a health care setting, is described. Smokers receiving medical care as inpatients or outpatients at the Ann Arbor (Mich.) Veterans Administration Hospital receive a brief consultation about their smoking from a health practitioner. (For inpatients, the consultation occurs near the time of the patient's discharge from the hospital.) Toward the end of the consultation, if the patient decides to try to quit smoking, he or she is given a self-help smoking cessation kit in a 3-week-diary format. With the practitioner, the smoker fills out the first series of exercises in the kit, including a smoking awareness test, and signs a stop-smoking contract, which is cosigned by the practitioner. The patient takes the kit home, where the remainder of the kit's instructions and exercises are to be followed. Compliance is encouraged by weekly telephone calls from the health practitioner to check on the patient's progress and by offering the patient a State lottery ticket for each week of the diary completed. Although the materials for this program were created for veterans using the Veterans Administration medical care system, the program can be adapted to a variety of health settings and can employ different types of health care practitioners--physicians, nurses, physician's assistants, and allied health care providers.
Efficacy of a nicotine nasal spray in smoking cessation: a placebo-controlled, double-blind trial. [2019]Laboratory trials have demonstrated the efficacy of nicotine replacement in smoking cessation but absolute success rates are low. For many, nicotine gum is hard to use and transdermal nicotine is slow-acting and passive. A new, faster-acting nicotine nasal spray (NNS) can provide easily self-administered relief from cigarette withdrawal. The NNS was tested for safety and efficacy in smoking cessation. Two hundred and fifty-five smokers were randomized to NNS or a piperine placebo. Drug use was limited to 8-32 doses/day for 6 months. Subjects were tested while smoking and at post-cessation daily (week 1) with follow-up at weeks 2, 3, 6 and at 3 months, 6 months and 1 year. Continuous abstinence analyses (CO