NRT + Quit Practice Strategies for Smoking Cessation

(ON-DEQ Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Amanda R Mathew, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Rush University Medical Center

Disqualifiers: Daily vaping, Pregnancy, Cardiovascular trauma, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Tobacco use disorder is a chronic, relapsing health condition that necessitates a chronic care approach. However, traditional smoking cessation treatment programs allocate nearly all their resources only to those smokers who are willing to set a quit date. This is problematic because few smokers are ready to set a quit date at any given time, and a smoker's stated intention to quit can change rapidly. One novel potential treatment strategy is to foster practice quitting (PQ), defined as attempting to not smoke for a few hours or days, without pressure or expectation to permanently quit. Although a growing body of evidence supports the role of practice quitting in fostering permanent quit attempts and cessation, there is a significant knowledge gap regarding which treatment strategies should be used to engage smokers in practice quitting. The proposed study will test the role of PQ counseling vs. Motivational Interviewing (MI) counseling, and NRT sampling (four-week supply of nicotine lozenges and patches) vs. none.

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.

What data supports the effectiveness of this treatment for smoking cessation?

Motivational Interviewing (MI) is a counseling technique that has shown promise in helping people quit smoking by encouraging behavior change. It was originally developed for alcohol abuse but has been applied to smoking cessation with some success, although results can vary. ^{1 2 3 4 5}

Is Motivational Interviewing (MI) safe for smoking cessation?

The research does not provide specific safety data for Motivational Interviewing (MI) in smoking cessation, but it is a widely recognized counseling approach used by healthcare professionals, suggesting it is generally considered safe. ^{3 6 7 8 9}

How is the treatment NRT + Quit Practice Strategies for Smoking Cessation different from other treatments for smoking cessation?

This treatment is unique because it combines Motivational Interviewing (MI) Counseling, which helps people find their own reasons to quit smoking, with Practice Quitting (PQ) Counseling, which provides practical strategies for attempting to quit. This approach is different from other treatments that may focus solely on medication or more directive counseling methods. ^{4 7 9 10 11}

Research Team

Amanda R Mathew, PhD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

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

I am 18 years old or older.

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

Not planning to quit in the next 30 days

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Rush University Medical Center Chicago, IL

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Patients Recruited

247,000+

Medical University of South Carolina

Collaborator

Trials

994

Patients Recruited

7,408,000+

Findings from Research

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing for smoking cessation. Lai, DT., Cahill, K., Qin, Y., 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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

References

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

Effectiveness of motivational interviewing to improve chronic condition self-management: what does the research show us? [2019]

2. England 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. [2007]

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

Training in motivational interviewing: a systematic review. [2022]

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

Motivational Interviewing: A High-Yield Interactive Session for Medical Trainees and Professionals to Help Tobacco Users Quit. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Motivational interviewing for smoking cessation. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Comparing primary care physicians' smoking cessation counseling techniques to motivational interviewing. [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

[Motivational interviewing and cognitive behavior therapy for smoking cessation]. [2022]

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

Motivational interviewing in an ordinary clinical setting: a controlled clinical trial at the Swedish National Tobacco Quitline. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Clinician acquisition and retention of Motivational Interviewing skills: a two-and-a-half-year exploratory study. [2022]

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

Enhanced motivational interviewing versus brief advice for adolescent smoking cessation: results from a randomized clinical trial. [2022]

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

Motivational interviewing for smoking cessation: a meta-analytic review. [2022]