Cognitive Behavioral Therapy + Nicotine Gum for Smoking Cessation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores ways to help Native Hawaiian adults quit smoking by testing nicotine gum and group counseling. Participants will join one of three groups: using only nicotine gum, attending only group counseling, or combining both methods. The goal is to determine which approach is most effective and accepted in this community. Eligible individuals currently smoke at least five cigarettes daily and live in specific public housing sites on O'ahu. As an unphased trial, this study provides participants the opportunity to contribute to culturally relevant smoking cessation strategies.
Will I have to stop taking my current medications?
Yes, you must stop using any prescription medications or nicotine replacement therapies to quit smoking during the 12-week study, except for what is provided by the research team. You also cannot use other tobacco, nicotine products, cannabis, or illicit drugs during this time.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that cognitive behavioral therapy (CBT) is generally safe and effective for helping people quit smoking. It is widely used and typically does not cause any serious side effects. CBT helps people change their thoughts and behaviors about smoking, aiding in the quitting process.
Studies have found that nicotine gum, such as the 2 mg version used here, is safe for most people. It does not contain the harmful tar or carbon monoxide found in cigarettes. Some individuals might experience mild side effects like headaches, indigestion, or mouth irritation, but these are common and not serious. The FDA has approved the gum for helping people quit smoking, supporting its safety.
Both methods are well-tolerated, making them good options for anyone considering joining a trial to quit smoking.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining cognitive behavioral therapy (CBT) with nicotine gum for smoking cessation because it offers a dual approach that targets both the psychological and physical aspects of addiction. Unlike standard treatments that often focus on just one of these aspects, the combination of CBT and nicotine gum provides mental support through therapy while also addressing nicotine cravings with a gradual tapering of the gum. This comprehensive approach could potentially lead to higher success rates in quitting smoking compared to using just therapy or nicotine replacement alone.
What evidence suggests that this trial's treatments could be effective for smoking cessation?
This trial will compare the effectiveness of different smoking cessation strategies. Participants in one arm will receive both nicotine gum and cognitive behavioral group therapy (CBGT), while another arm will receive only CBGT, and a third arm will receive only nicotine gum. Studies have shown that cognitive behavioral therapy (CBT) can significantly aid smoking cessation. One analysis found that people using CBT were four times more likely to quit smoking than those who did not use this method. Specifically, another study showed that 23.6% of people successfully quit smoking after three months of group-based CBT.
Research also indicates that nicotine gum effectively helps people quit smoking. One study found that people using nicotine gum had a higher success rate at quitting after three months compared to those using a placebo. The gum has been shown to aid smoking cessation when included in a comprehensive plan.
Combining both methods—nicotine gum and CBT—might yield even better results, as each has proven effective independently.14678Who Is on the Research Team?
Crissy T Kawamoto
Principal Investigator
University of Hawai'i Cancer Center
Pallav Pokhrel, PhD, MPH
Principal Investigator
University of Hawai'i Cancer Center
Are You a Good Fit for This Trial?
This trial is for Native Hawaiian adults who want to quit smoking. Participants will be recruited from public housing sites on O'ahu and must be willing to try nicotine gum, group counseling, or both. Specific eligibility criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either nicotine gum, group counseling, or both over a 12-week period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive Behavioral Group Therapy (CBGT)
- Nicotine Polacrilex Gum (2 mg)
Trial Overview
The study tests the effectiveness of nicotine gum (2 mg), cognitive behavioral group therapy (CBGT), or a combination of both in helping participants quit smoking. They'll be randomly placed into one of three groups to see which method is most effective within this community.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Participants receive nicotine gum (2 mg) according to a 12-week FDA-approved tapering schedule. No counseling is provided.
Participants attend six weekly sessions of cognitive-behavioral group therapy (CBGT) for smoking cessation. No nicotine gum is provided.
Participants receive both nicotine gum (2 mg, tapered over 12 weeks) and attend six weekly CBGT sessions for smoking cessation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Hawaii
Lead Sponsor
Citations
Comparative Effectiveness of Group-Delivered Acceptance ...
One-year cessation rates did not differ between group-based ACT and CBT, suggesting ACT-based intervention is a reasonable alternative to CBT-based counseling ...
Effect of cognitive behavior therapy on abstinence among ...
The pooled analysis revealed that CBT significantly improved smoking abstinence rates, demonstrating a fourfold increase in effectiveness ...
Preliminary Efficacy of a Cognitive Behavioral Therapy– ...
In this study, our main results indicate that (1) the 4-week continuous smoking cessation rate of the intervention group participants (30/101, ...
Long-Term Effectiveness of a Clinician-Assisted Digital ...
This study established the long-term effectiveness of an extended CBT-based intervention; results may inform implementation of scalable ...
5.
journals.lww.com
journals.lww.com/ijebh/fulltext/2014/09000/the_effect_of_adolescent_cognitive_behavioral.94.aspxThe effect of adolescent cognitive behavioral group therapy ...
In this study,we evaluated the effect of cognitive behavioral group therapy on smoking cessation and found a success rate of 23.6% after three months.
Hypnotherapy compared to cognitive-behavioral therapy ...
The aim of the present study was to compare the efficacy of a hypnotherapeutic group program for smoking cessation with that of an established cognitive- ...
Cognitive Behavioral Therapy versus General Health ...
The current study evaluated the efficacy of group CBT for tobacco cessation across the three largest racial and ethnic groups in the U.S. This was a dual-site ...
Initial assessment of a novel smoking cessation program ...
A prospective 6-month single-arm pilot study was conducted; 71 adults who smoked and were motivated to quit received a cognitive behavioral ...
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