631 Participants Needed

Varenicline + NRT for Smoking Cessation

Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This randomized pilot phase IV trial studies the side effects and how well varenicline works compared to nicotine replacement therapy in helping patients that smoke to quit. Varenicline is a drug that acts the same way as nicotine in the brain but is not habit-forming. Nicotine replacement therapy consists of nicotine patches and lozenges. It is not yet known if varenicline is more effective than nicotine replacement therapy in helping patients quit smoking.

Do I need to stop taking my current medications to join the trial?

The trial requires you to stop using certain smoking cessation medications like Wellbutrin, Bupropion, Zyban, nicotine replacement therapy, and Chantix at least 7 days before joining. If you are taking certain depression medications like MAOIs or Elavil, you need to stop 14 days before. Other medications will be evaluated on a case-by-case basis by the study physician.

What data supports the effectiveness of the drug Varenicline combined with Nicotine Replacement Therapy for smoking cessation?

Research shows that Varenicline, known as Chantix, is effective for quitting smoking, with higher success rates compared to other treatments like bupropion and placebo. Additionally, both Varenicline and combination nicotine replacement therapy (cNRT) are recommended as effective options for smoking cessation, with similar success rates in helping people quit smoking.12345

Is the combination of Varenicline and Nicotine Replacement Therapy (NRT) safe for smoking cessation?

Varenicline, known as Chantix or Champix, has been associated with some safety concerns, including potential neuropsychiatric side effects like depression and suicidal thoughts, as well as interactions with alcohol. While it is effective for smoking cessation, these risks should be discussed with a healthcare provider.16789

What makes the drug Varenicline unique for smoking cessation?

Varenicline is unique for smoking cessation because it works by partially stimulating nicotine receptors in the brain, reducing cravings and withdrawal symptoms, while also blocking the pleasurable effects of nicotine from cigarettes.1011121314

Research Team

JR

Jason Robinson

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adult cigarette smokers who smoke at least 5 cigarettes a day, are interested in quitting, and can follow instructions in English. They must not use other tobacco products frequently or be on certain medications like smoking cessation drugs or some antidepressants. People with severe kidney or liver disease, uncontrolled high blood pressure, recent heart issues, or unstable psychiatric conditions cannot join.

Inclusion Criteria

You have an address and telephone number where he/she may be reached.
Smoking 5 or more cigarettes, little cigars and/or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbon monoxide (CO) greater than or equal to 6 parts per million (ppm) (if less than or equal to 5, then positive cotinine test)
Interested in treatment that might change smoking behavior
See 3 more

Exclusion Criteria

I have severe kidney or liver disease.
I have not had a serious or unstable illness in the last 3 months.
Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator and/or study physician
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either varenicline or nicotine replacement therapy for smoking cessation, with behavioral counseling over 12 weeks

12 weeks
4 in-person visits, 4 phone visits, 4 brief supportive phone calls

Re-randomization and Additional Treatment

Participants who fail to achieve abstinence at week 6 are re-randomized to receive 6 additional weeks of therapy, either continuing the same treatment, switching to the other treatment, or receiving a high-dose version

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Follow-up at 3 and 6 months

Treatment Details

Interventions

  • Nicotine Lozenge
  • Nicotine Patch
  • Varenicline
Trial Overview The study compares the effectiveness of varenicline (a non-addictive nicotine-like drug) to nicotine replacement therapy (patches and lozenges) combined with counseling to help people quit smoking. It's a randomized pilot phase IV trial where participants are randomly assigned to either treatment without knowing which one they're getting.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group I (varenicline and placebo)Experimental Treatment3 Interventions
Patients receive varenicline PO QD or BID, placebo patches QD, and placebo lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients that are abstinent at week 6 may continue treatment for an additional 6 weeks. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.
Group II: Group II (placebo, nicotine patch and lozenge)Placebo Group4 Interventions
Patients receive placebo tablets PO QD or BID, nicotine patches QD, and nicotine lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients that are abstinent at week 6 may continue treatment for an additional 6 weeks. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.

Varenicline is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Chantix for:
  • Smoking cessation
  • Dry eye disease
🇪🇺
Approved in European Union as Champix for:
  • Smoking cessation
🇨🇦
Approved in Canada as Champix for:
  • Smoking cessation

Find a Clinic Near You

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+

Findings from Research

In a randomized controlled trial, varenicline (Chantix) demonstrated a higher abstinence rate from smoking after one year compared to both bupropion SR (Zyban) and a placebo, indicating its efficacy in treating tobacco dependence.
Despite its effectiveness, varenicline has been associated with serious neuropsychiatric side effects, highlighting the importance of discussing potential risks and benefits with patients considering this treatment.
Treatment of nicotine dependence with Chantix (varenicline).Rankin, KV., Jones, DL.[2015]
In a study of 3569 smokers, those using varenicline had a significantly higher sustained abstinence rate (15.2%) compared to those using combination nicotine replacement treatment (cNRT) (10.3%) over a 12-month period, indicating that varenicline may be more effective for long-term smoking cessation.
The study highlights that varenicline's effectiveness was observed in a real-world setting, where participants chose their treatment and received structured support, suggesting that it could be a preferred option for smoking cessation programs.
Effectiveness of Varenicline Versus Combination Nicotine Replacement Therapy for Smoking Cessation: One-Year Outcomes in a Smoking Cessation Clinic in Taiwan.Hsueh, KC., Tang, PL., McRobbie, H.[2021]
Participants who chose varenicline (3,116 individuals) for tobacco cessation had higher abstinence rates at both 3 months (22%) and 6 months (17%) compared to those using nicotine replacement therapy (NRT) (13% at 3 months and 11% at 6 months), indicating that varenicline may be more effective in supporting quitting.
The study found that factors such as increasing age, having health insurance, and the number of counseling sessions were associated with higher rates of abstinence, particularly at 3 months, suggesting that these factors could enhance the effectiveness of quitline services.
Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy.Biazzo, LL., Froshaug, DB., Harwell, TS., et al.[2015]

References

Treatment of nicotine dependence with Chantix (varenicline). [2015]
Effectiveness of Varenicline Versus Combination Nicotine Replacement Therapy for Smoking Cessation: One-Year Outcomes in a Smoking Cessation Clinic in Taiwan. [2021]
Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. [2015]
[Drug of the month. Varenicline (Champix)]. [2015]
Varenicline: a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist approved for smoking cessation. [2017]
Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. [2018]
Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. [2015]
Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study. [2021]
[Sustainable efficacy of oral varenicline for smoking cessation]. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Vinorelbine tartrate: a promising new chemotherapeutic agent. [2018]
A phase I pharmacokinetic study of bexarotene with vinorelbine and cisplatin in patients with advanced non-small-cell lung cancer (NSCLC). [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Multi-institutional phase I/II trial of oral bexarotene in combination with cisplatin and vinorelbine in previously untreated patients with advanced non-small-cell lung cancer. [2022]
A Phase I Comparative Pharmacokinetic and Safety Study of Two Intravenous Formulations of Vinorelbine in Patients With Advanced Non-Small Cell Lung Cancer. [2020]
14.United Statespubmed.ncbi.nlm.nih.gov
Respiratory failure following vinorelbine tartrate infusion in a patient with non-small cell lung cancer. [2019]