NRT + Quit Practice Strategies for Smoking Cessation

(ON-DEQ Trial)

Overseen By Amanda R Mathew, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Rush University Medical Center

Disqualifiers: Daily vaping, Pregnancy, Cardiovascular trauma, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

780 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help people quit smoking by testing various counseling and nicotine replacement therapy (NRT) approaches. It compares two counseling types: Practice Quitting, which encourages short, pressure-free attempts to stop smoking, and Motivational Interviewing, which enhances motivation to quit. Participants will receive either a supply of nicotine lozenges and patches or none at all. Smokers who have been smoking at least five cigarettes a day, are not planning to quit within the next month, and want to learn about reducing smoking or quitting in the next six months might be a good fit for this study. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking smoking cessation strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have any FDA contraindications for nicotine replacement therapy (NRT), such as recent cardiovascular issues, you may be excluded from the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that nicotine replacement therapy (NRT), such as patches and lozenges, is generally safe for adults who want to quit smoking. Many people use NRT to manage cravings and withdrawal symptoms. While some side effects may occur, they are usually mild, such as headaches, nausea, or dizziness. The US Food and Drug Administration (FDA) provides guidelines to ensure the safe use of these therapies.

Motivational Interviewing (MI) counseling has proven effective in helping people quit smoking by increasing their motivation and commitment. Studies confirm that MI is effective and generally well-received by those trying to quit.

Practice Quitting (PQ) counseling is a newer method with limited safety data. However, it involves short-term attempts to stop smoking, which is low-risk. While specific safety data is limited, the method itself is non-invasive and considered safe.

Overall, these treatments aim to help people stop smoking and have shown promising safety profiles in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores different counseling strategies combined with nicotine replacement therapy (NRT) to help people quit smoking. The trial is unique as it compares the effectiveness of Motivational Interviewing (MI) and Practice Quitting (PQ) counseling, two behavioral techniques designed to boost motivation and prepare individuals for a successful quit attempt. Unlike standard methods that might rely solely on NRT or generic advice, this trial aims to uncover how tailored behavioral support can enhance quitting success. By understanding which combination works best, researchers hope to offer more personalized and effective quitting strategies for smokers.

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

This trial will evaluate different strategies for smoking cessation, including Nicotine Replacement Therapy (NRT) and behavioral counseling methods. Studies have shown that NRT, which some participants will receive, can more than double the chances of successfully quitting smoking by providing a small amount of nicotine to reduce cravings and withdrawal symptoms. Other participants will receive Motivational Interviewing (MI) counseling, which research suggests can help people quit smoking by boosting motivation and readiness to quit, although its effects are usually modest. Additionally, some participants will experience Practice Quitting (PQ) counseling, which, while less researched, provides structured support known to increase the chances of quitting. Overall, each of these methods has shown promise in helping people quit smoking, and they work in different ways to support efforts to quit. ^{3 6 7 8 9}

Who Is on the Research Team?

Amanda R Mathew, PhD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults in the continental U.S. who smoke daily (5+ cigarettes) and aren't planning to quit within 30 days but are considering quitting or reducing smoking within 6 months. They must have a smartphone for study procedures. It's not for those who vape daily, are pregnant/breastfeeding, or have had recent heart attacks or strokes.

Inclusion Criteria

Have access to a smartphone that can be used to complete study procedures

Not planning to quit in the next 30 days

Not currently engaged in smoking cessation treatment

Exclusion Criteria

I haven't had a recent heart attack or similar heart issue.

Excluded for daily vaping/electronic cigarettes use (i.e., use for ≥ 25 days within past 30 days)

I haven't had a stroke in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PQ counseling vs. Motivational Interviewing and NRT sampling (four-week supply of nicotine lozenges and patches) vs. none

4 weeks

Follow-up

Participants are monitored for quit attempts and abstinence status at 1, 3, and 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Motivational Interviewing (MI) Counseling
• Nicotine Replacement Therapy (NRT) Sampling
• Practice Quitting (PQ) Counseling

Trial Overview

The study tests whether Practice Quitting (PQ) counseling, Motivational Interviewing (MI), or Nicotine Replacement Therapy (NRT) sampling helps smokers practice quitting—trying not to smoke temporarily without pressure to quit permanently.

How Is the Trial Designed?

Group I: Condition #4 Experimental Treatment 1 Intervention

NRT sampling = Off Behavioral counseling = Motivational Interviewing

Group II: Condition #3 Experimental Treatment 2 Interventions

NRT sampling = On Behavioral counseling = Motivational Interviewing

Group III: Condition #2 Experimental Treatment 1 Intervention

NRT Sampling = Off Behavioral Counseling = Practice Quitting

Group IV: Condition #1 Experimental Treatment 2 Interventions

NRT Sampling = On Behavioral Counseling = Practice Quitting

Motivational Interviewing (MI) Counseling is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Motivational Interviewing Counseling for:

• Smoking cessation
• Substance abuse treatment

Approved in Canada as Motivational Interviewing Counseling for:

• Smoking cessation
• Addiction treatment

Approved in European Union as Motivational Interviewing Counseling for:

• Smoking cessation
• Behavioral therapy

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

Motivational interviewing (MI) significantly improved long-term smoking cessation rates in nonpregnant individuals, showing a 2.3% higher abstinence rate compared to other interventions, based on a meta-analysis of 31 controlled trials.

The effectiveness of MI was particularly notable in specific subgroups, such as younger participants and those with lower motivation to quit, while effects were smaller in pregnant individuals, suggesting tailored approaches may enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing for smoking cessation: a meta-analytic review. Hettema, JE., Hendricks, PS.[2022]

In a study involving 772 clients at the Swedish National Tobacco Quitline, adding motivational interviewing (MI) to standard smoking cessation treatment increased the rate of continuous abstinence from smoking at 6 months by 5%.

Clients who received MI had a 19% continuous abstinence rate compared to 14% for those receiving standard treatment, indicating that MI can enhance the effectiveness of smoking cessation programs in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing in an ordinary clinical setting: a controlled clinical trial at the Swedish National Tobacco Quitline. Lindqvist, H., Forsberg, LG., Forsberg, L., et al.[2022]

Motivational interviewing (MI) is a client-centered counseling approach that aims to promote behavior change, particularly in areas like diet and physical activity, and has its origins in addiction treatment.

While MI shows promise in helping patients make lifestyle changes, research results are mixed, indicating a need for further investigation into its implementation and effectiveness across different patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of motivational interviewing to improve chronic condition self-management: what does the research show us? Coyne, N., Correnti, D.[2019]

Motivational Interviewing (MI) has been shown to significantly increase smoking cessation rates compared to brief advice or usual care, with a relative risk of 1.27 based on a meta-analysis of 14 studies involving over 10,000 smokers.

The effectiveness of MI is enhanced when delivered by primary care physicians or counselors, particularly in longer sessions (over 20 minutes), suggesting that the method can be a valuable tool in smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing for smoking cessation. Lai, DT., Cahill, K., Qin, Y., et al.[2022]

Combining counseling techniques like Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) with medication is crucial for effective smoking cessation, as MI helps those reluctant to quit and CBT supports those who want to quit but struggle.

Despite their proven effectiveness in the U.S. for various groups, including those with depression or weight concerns, MI and CBT are not widely practiced in Japan, highlighting a gap in smoking cessation treatment that could be addressed by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Motivational interviewing and cognitive behavior therapy for smoking cessation]. Kawai, A., Kano, M., Sato, T.[2022]

A 1-hour hands-on training session in motivational interviewing (MI) significantly improved pediatric residents' skills in addressing tobacco use, as evidenced by better performance on the Behavior Change Counseling Index (BECCI) compared to those who did not attend the session.

Practitioners who participated in the American Academy of Pediatrics (AAP) tobacco training reported a doubling in their comfort level with counseling about tobacco, indicating that MI training can effectively enhance clinicians' confidence and ability to help patients quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Interviewing: A High-Yield Interactive Session for Medical Trainees and Professionals to Help Tobacco Users Quit. Boykan, R., Gorzkowski, J., Marbin, J., et al.[2023]

Motivational interviewing (MI) showed some effectiveness in reducing the number of cigarettes smoked per day among adolescents, with significant decreases reported at the 1-month follow-up, although overall abstinence rates were low and did not differ significantly from brief advice (BA).

MI was effective in changing adolescents' perceptions of peer and adult smoking norms, which could be beneficial for future smoking interventions, but it did not lead to higher motivation or self-efficacy to quit smoking compared to BA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced motivational interviewing versus brief advice for adolescent smoking cessation: results from a randomized clinical trial. Colby, SM., Nargiso, J., Tevyaw, TO., et al.[2022]

Counsellors at the Swedish National Tobacco Quitline showed overall improvement in motivational interviewing (MI) skills over a two-and-a-half year period, indicating that ongoing supervision can enhance MI effectiveness.

However, significant variations in MI skills among different counsellors and fluctuations in their performance over time highlight the need for continuous feedback and the importance of using validated assessment tools to maintain MI integrity in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician acquisition and retention of Motivational Interviewing skills: a two-and-a-half-year exploratory study. Forsberg, L., Forsberg, LG., Lindqvist, H., et al.[2022]

In a study analyzing 73 audio-recorded smoking cessation discussions between primary care physicians and patients, it was found that physicians exhibited motivational interviewing (MI) adherent behaviors in 56% of their interactions, indicating a solid foundation of MI skills.

However, there was also a significant presence of MI nonadherent behaviors (57%), suggesting that training programs could enhance physicians' MI techniques, particularly in areas like seeking patient permission and reducing directive approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing primary care physicians' smoking cessation counseling techniques to motivational interviewing. Werner, JJ., Lawson, PJ., Panaite, V., et al.[2021]

Motivational interviewing (MI) is a recognized and effective counseling approach, leading to increased demand for training among healthcare professionals.

This systematic review consolidates research on MI training, detailing the populations trained, methods used, and outcomes, while also identifying which stages of the MI learning process were addressed in various studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training in motivational interviewing: a systematic review. Madson, MB., Loignon, AC., Lane, C.[2022]

In a study of 163 smoking counseling sessions for postpartum women, 49.4% demonstrated good adherence to the principles of Motivational Interviewing (MI), indicating a satisfactory level of implementation.

Clients who were non-smokers were 3.1 times more likely to receive a good MI session compared to daily smokers, and higher adherence to MI was significantly associated with better smoking outcomes after 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the principles of Motivational Interviewing, clients' characteristics and behavior outcome in a smoking cessation and relapse prevention trial in women postpartum. Thyrian, JR., Freyer-Adam, J., Hannöver, W., et al.[2007]

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