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

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

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

630 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to offer lung cancer screenings to smokers who want to change their smoking behaviors. All eligible participants will receive smoking cessation counseling and may be offered at least one form of smoking cessation drug. Different forms of counseling (the delivery of counseling and access to counseling) will be compared. This is an investigational study. Participants on this study will not be prescribed smoking drugs directly by the study staff. However, participants in this study may or may not receive smoking cessation drugs, depending on what the provider thinks is in the participants best interest. All smoking cessation drugs being used are FDA approved and commercially available. It is investigational to compare the different forms of counseling participants receive. Up to 1260 participants will be enrolled in this study. All will take part at MD Anderson.

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.

What data supports the effectiveness of the smoking cessation treatment?

Research shows that combining counseling with pharmacotherapy, like nicotine patches and other medications, can significantly increase the chances of successfully quitting smoking. Studies indicate that these combined approaches can double the odds of quitting compared to trying to quit without any support. ^{1 2 3 4 5}

Is the combination of smoking cessation counseling and pharmacotherapy safe for humans?

Research shows that smoking cessation counseling and pharmacotherapy are generally safe for humans, with some studies reviewing their safety and noting frequently reported side effects. These treatments are recommended for helping people quit smoking, and any side effects are usually mild and manageable. ^{1 6 7 8 9}

How is Cessation Counseling + Pharmacotherapy unique for smoking cessation?

Cessation Counseling combined with pharmacotherapy is unique because it integrates behavioral support with medication, which can improve the chances of quitting smoking compared to using medication or counseling alone. This approach allows for personalized treatment plans that can be tailored to individual needs, potentially increasing the success rate of smoking cessation. ^{1 2 3 6 10}

Research Team

Jason D Robinson, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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 am 50 years old or older.

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

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

References

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

Impact of Adding Telephone-Based Care Coordination to Standard Telephone-Based Smoking Cessation Counseling Post-hospital Discharge: a Randomized Controlled Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Smoking cessation treatment in a real-life setting: the Greek experience. [2015]

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

Effects of copayment on initiation of smoking cessation pharmacotherapy: an analysis of varenicline reversed claims. [2015]

4. Italy pubmed.ncbi.nlm.nih.gov

Effectiveness of pharmacologic therapies on smoking cessation success: three years results of a smoking cessation clinic. [2023]

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

Maximizing smoking cessation in clinical practice: pharmacologic and behavioral interventions. [2023]

6. Colombia pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of medication use for the cessation of tobacco addiction: A review of Clinical Practice Guidelines]. [2018]

7. Mexico pubmed.ncbi.nlm.nih.gov

[Counseling interventions for smoking cessation: systematic review]. [2019]

8. Canada pubmed.ncbi.nlm.nih.gov

Update on pharmacologic and nonpharmacologic therapies for smoking cessation. [2021]

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

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. [2021]

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

Smoking cessation through the utilization of pharmacotherapy. [2010]