Smoking Cessation Counseling + Pharmacotherapy for Smoking Cessation

Overseen By Paul Cinciripini, PHD, MS, BS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Smoking cessation meds

Disqualifiers: Pregnancy, Other smoking programs, others

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

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people who smoke by offering lung cancer screenings and exploring ways to support quitting smoking. Participants will receive counseling to assist with smoking cessation and might be offered smoking cessation drugs, such as an anti-smoking drug or a nicotine patch, based on their provider's advice. The study will compare different counseling methods to determine which is most effective. Those who have smoked in the last 30 days and are interested in changing their smoking habits might be a good fit.

As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

If you are currently using smoking cessation medications like Wellbutrin, Bupropion, Zyban, NRT, or Chantix as part of a quit attempt, you will need to stop taking them at least 7 days before joining the study.

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

A previous study showed that nicotine patches help people quit smoking by reducing cravings. Considered safer than smoking, they can still cause some side effects. Reports include nausea, diarrhea, and skin irritation. These patches are widely available and FDA-approved, indicating general safety for most people. However, keep them away from children, as even small amounts of nicotine can be harmful. For those considering nicotine patches in this trial, it is reassuring that they have been well-studied, and most side effects are manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different approaches to smoking cessation that combine counseling and pharmacotherapy. The Quitline (QL) group provides brief cessation counseling and ongoing support through a Quitline with nicotine replacement therapy (NRT), offering a structured yet accessible support system. The Quitline-Rx (QL-Rx) group adds a personalized pharmacotherapy discussion with a healthcare provider, tailoring treatment to individual needs. Lastly, the Integrated Care (IC) group partners with a Tobacco Treatment Program for more intensive support, including 4-8 counseling sessions and medication over a longer period. This trial aims to determine which combination is most effective in helping individuals quit smoking, offering insights that could enhance current smoking cessation strategies.

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

Research has shown that counseling, which participants in this trial will receive, can significantly aid in quitting smoking. With counseling, 26.5% to 35.3% of individuals successfully quit, compared to just 3% to 5% who attempt to quit without support.

In this trial, some participants will also use the nicotine patch, a popular medication option. Studies indicate that individuals using the nicotine patch are more than twice as likely to quit smoking than those using a placebo patch. Combining the nicotine patch with other nicotine replacement products can enhance effectiveness. These methods, when paired with counseling, offer strong support for those aiming to quit smoking. ^{6 7 8 9 10}

Who Is on the Research Team?

Jason D Robinson, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for smokers over 50 who want to quit and are eligible for lung cancer screening. They must be able to follow instructions in English, not be using other cessation programs or products, and agree to counseling and potential pharmacotherapy. Pregnant women or those on certain medications are excluded.

Inclusion Criteria

I have smoked in the last 30 days and am open to treatments that could help me quit.

I am 50 years old or older.

I am medically cleared to use medications to help me stop smoking.

Exclusion Criteria

I am not pregnant, breastfeeding, and if of childbearing potential, I am using effective birth control.

You use tobacco products other than cigarettes or little cigars, like cigars, chewing tobacco, snuff, pipes, or e-cigarettes.

Current enrollment or plans to enroll in another smoking cessation program in the next 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

0-4 days

1 visit (in-person)

Treatment

Participants receive smoking cessation counseling and may be offered smoking cessation drugs over 12 weeks

12 weeks

5-8 visits (in-person)

Follow-up

Participants are monitored for smoking behavior and other health indicators after treatment

6 months

3 visits (in-person), 1 call (phone)

What Are the Treatments Tested in This Trial?

Interventions

• Anti-Smoking Drug
• Cessation Counseling
• Nicotine Patch
• Shared Decision Making + Video

Trial Overview The study tests different smoking cessation counseling methods plus the option of FDA-approved drugs like Nicotine Patches or anti-smoking medication. Participants will also receive a low-dose CT scan as part of lung cancer screening at MD Anderson.

How Is the Trial Designed?

Group I: Quitline-Rx (QL-Rx) Group Experimental Treatment 8 Interventions

Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider. LDCT provider and patient discuss options for pharmacotherapy. Participants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks.

Group II: Quitline (QL) Group Experimental Treatment 7 Interventions

Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider. Participants given shared decision making and discussion about screening with the LDCT provider. Participants referred to the Quitline for counseling and NRT (nicotine patch). Participants have 5 smoking cessation counseling sessions over the next 12 weeks.

Group III: Integrated Care (IC) Group Experimental Treatment 8 Interventions

Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider. Participant referred to Tobacco Treatment Program (TTP). TTP provides 4-8 counseling sessions and pharmacotherapy over a 10-12 week period,

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Smoking cessation counseling provided by physicians and trained health professionals can lead to abstinence rates between 2.1% and 17.4%, indicating some effectiveness in helping people quit smoking.

However, the overall clinical effect of smoking cessation counseling is considered low, and long-term cessation rates remain uncertain, suggesting a need for further cost-effectiveness analyses before widespread implementation in public health programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Counseling interventions for smoking cessation: systematic review]. Alba, LH., Murillo, R., Castillo, JS.[2019]

In a study involving 8144 participants, varenicline and bupropion were associated with specific adverse events (AEs) like nausea and insomnia compared to the nicotine patch, but overall, these treatments were well tolerated with less than 1.5% of participants experiencing severe AEs.

Most reported AEs were manageable and not clinically significant, allowing healthcare providers to reassure patients about the safety of these smoking cessation pharmacotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. Ebbert, J., Jimenez-Ruiz, C., Dutro, MP., et al.[2021]

Smoking cessation is crucial for disease prevention, with 70% of smokers wanting to quit, but only 3-5% succeed without intervention, highlighting the need for effective support.

Recent advancements in pharmacotherapies, including nicotine replacement therapy, bupropion, and varenicline, provide clinicians with options to personalize treatment, potentially increasing the success rate of quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation through the utilization of pharmacotherapy. Harrington, KF., Bailey, WC.[2010]

Clinicians can significantly reduce cardiovascular risks by actively helping patients quit smoking, which includes documenting smoking status and providing strong advice to quit at every visit.

Effective pharmacotherapies like nicotine replacement, bupropion, and varenicline can double the chances of quitting, but comprehensive support such as behavioral counseling and follow-up is often lacking, highlighting the need for referrals to specialized quitlines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing smoking cessation in clinical practice: pharmacologic and behavioral interventions. Nides, M., Leischow, S., Sarna, L., et al.[2023]

In a study of 895 smokers, those treated with bupropion SR combined with behavioral therapy achieved post-treatment abstinence rates of up to 71.6%, indicating that this combination is highly effective for smoking cessation.

Long-term follow-up showed that predictors for sustained abstinence after one year included the use of bupropion SR, lower nicotine addiction, and the smoker's motivation, highlighting the importance of both medication and personal commitment in achieving lasting results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation treatment in a real-life setting: the Greek experience. Rovina, N., Nikoloutsou, I., Dima, E., et al.[2015]

Varenicline, a new pharmacologic aid for smoking cessation, has been shown to be more effective than both placebo and bupropion, making it a strong option for smokers trying to quit, based on level I evidence from randomized controlled trials.

Combining pharmacologic therapies like varenicline with nonpharmacologic approaches, such as counseling, significantly increases the chances of successfully quitting smoking, despite some mild to moderate side effects like nausea and insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on pharmacologic and nonpharmacologic therapies for smoking cessation. Schmelzle, J., Rosser, WW., Birtwhistle, R.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10858725/

A Review of Smoking Cessation Interventions - PubMed Central Moreover, attempting to quit smoking without any structured approach yielded a mere 3%-5% success rate within the same timeframe [7]. This study ...

2. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7329a1.htm

Adult Smoking Cessation — United States, 2022 | MMWR CDC assessed national estimates of cigarette smoking cessation indicators among U.S. adults using 2022 National Health Interview Survey data.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6342013/

Long-Term Outcomes from Repeated Smoking Cessation ... Overall, 20% of the cohort achieved LTQ status. Patients with ≥75% of visits with any assistance had almost three times the odds of achieving LTQ status ...

4. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-024-02570-9

Effectiveness of smoking cessation interventions among adults Results suggest that pharmacological and behavioural interventions may help the general smoking population quit smoking with observed small/mild harms ...

5. academic.oup.com academic.oup.com/ntr/article/26/4/452/7335860

Real-Life Effectiveness of Smoking Cessation Delivery Modes ... Quit success 12 months after counseling varied from 26.5 to 35.3% (Table 2). No significant differences in quit success 12 months after counseling were found ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/020165Orig1s047lbl.pdf

Nicoderm CQ - accessdata.fda.gov This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

7. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9GLAXC_NICODERM_NICOTINE_PATCH1.pdf

SAFETY DATA SHEET Conditions to avoid. Strong acids. Strong oxidizing agents. Incompatible materials. 4 / 9. Material name: NICODERM CQ. 1697 Version #: 15 ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/nicotine-transdermal-route/description/drg-20068808

Nicotine (transdermal route) - Side effects & dosage Safety and efficacy have not been established. Small amounts of nicotine can cause serious unwanted effects in children, and patches contain ...

9. nicorette.com nicorette.com/shop/patch/?srsltid=AfmBOornp1l4h09raHcpNabP9YJZRpdAZ2ArVadT18Knc2bwb3f604Em

NicoDerm CQ Nicotine Patches: Relief You Can Wear Buy NicoDerm CQ patches from Nicorette to help you quit smoking. You can wear these nicotine patches under your clothes to ease your cravings discreetly.

10. goodrx.com goodrx.com/health-topic/nicotine/nicotine-patch-side-effects?srsltid=AfmBOoqip4P8Ukyy3u-o_wgJWGWx-EGNiONRwOPgwoZpVyXfGcVu37yy

8 Nicotine Patch Side Effects and How to Manage Them Nicotine patches help lower the risk of having nicotine withdrawal symptoms when you stop smoking. These symptoms include nausea, diarrhea ...