Varenicline for Smoking

Not yet recruiting at 3 trial locations

Overseen By Elana G Brubaker, MSW BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: VA Office of Research and Development

Must not be taking: Smoking cessation drugs

Disqualifiers: Non-cigarette tobacco, Incarceration, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called varenicline to assist Veterans who smoke but aren't ready to quit entirely. Researchers aim to determine if varenicline can encourage more quit attempts and long-term success in quitting. The study also compares varenicline with a nicotine mini-lozenge, both designed to reduce smoking. Veterans who smoke at least five cigarettes daily and wish to cut down, but aren't ready to quit in the next 30 days, might be suitable candidates. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you are not currently using any medications for smoking cessation. If you are using such medications, you would need to stop them to participate.

What is the safety track record for these treatments?

Studies have shown that varenicline is generally safe for helping people quit smoking. In clinical trials, nausea was the most common side effect, affecting about 28% of participants, compared to 8% of those taking a placebo. Other common side effects included headaches. Research has proven that varenicline effectively increases the chances of quitting smoking.

The FDA has already approved this medication for smoking cessation, confirming its safety. While side effects like nausea can occur, many find the benefits outweigh these issues. Discussing any concerns with a healthcare provider before starting treatment is always advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Varenicline for smoking cessation because it targets nicotine addiction by acting on specific brain receptors, reducing cravings and withdrawal symptoms. Unlike nicotine replacement therapies, such as patches or lozenges, which supply low doses of nicotine to ease withdrawal, Varenicline works by partially stimulating the same receptors nicotine does, while also blocking nicotine’s ability to fully activate them. This dual action makes it unique and potentially more effective in helping smokers reduce their habit and eventually quit. Additionally, using Varenicline during the pre-quit phase could help enhance motivation and commitment to quit smoking.

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

Research has shown that varenicline, which participants in this trial may receive, effectively helps people quit smoking. One study found that 68.97% of people using varenicline successfully quit, compared to 31.03% of those using bupropion. Another study revealed that after 12 weeks of treatment, about 40% of people taking varenicline quit smoking, while only 8.3% of a control group did. Extending varenicline treatment from 12 to 24 weeks further reduces the chances of relapse and supports long-term cessation. Overall, varenicline is a strong option for quitting smoking. ^{5 6 7 8 9}

Who Is on the Research Team?

Jessica Megan Cook, PhD

Principal Investigator

William S. Middleton Memorial Veterans Hospital, Madison, WI

Neal M Doran, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for veterans with a smoking addiction who aren't ready to quit yet. It's designed to help increase their chances of making quit attempts and achieving long-term abstinence from smoking.

Inclusion Criteria

If female, use an approved method of birth control while using study medication

Report smoking an average of 5 or more cigarettes daily for the previous 6 months

Be a Veteran

Exclusion Criteria

Use of non-cigarette tobacco products as primary form of tobacco use

Incarceration

I am unable to understand or agree to the study on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Motivation-Phase Treatment

Participants receive either varenicline or NRT mini-lozenges for 12 weeks, along with 5 phone counseling sessions focused on smoking reduction

12 weeks

5 visits (phone counseling)

Follow-up

Participants are monitored for smoking abstinence and quit attempts at 6 and 12 months post-study entry

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Varenicline

Trial Overview The study tests different treatments: Varenicline (a medication) during both motivation and cessation phases, counseling in both phases, nicotine mini-lozenges during the motivation phase, and combination nicotine replacement therapy (NRT) during cessation.

How Is the Trial Designed?

Group I: Motivation-Phase Varenicline Experimental Treatment 4 Interventions

Varenicline use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking.

Group II: Motivation-Phase Nicotine Mini-Lozenge Active Control 4 Interventions

NRT mini-lozenge use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4824380/

Varenicline for smoking cessation: a narrative review of ... Extending the use of varenicline from 12 to 24 weeks reduces relapse and improves smoking cessation outcomes.

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2818356

Smoking Cessation After Initial Treatment Failure With ... On average, varenicline and combined nicotine replacement therapy (CNRT) appear to consistently produce the highest levels of long-term ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.70235?af=R

Efficacy of combined varenicline and nicotine replacement ... Low-certainty evidence indicates that combining varenicline with nicotine replacement therapy may improve long-term smoking cessation rates ...

4. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/Determinants-of-successful-smoking-cessation-in-outpatient-settings-A-comparative,208449,0,2.html

Determinants of successful smoking cessation in outpatient ... Varenicline users showed a significantly higher quitting success rate (68.97%) compared to bupropion users (31.03%; p=0.013). Additionally, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589537023004935

Varenicline for smoking cessation in individuals who ... In the paper of Ebbert et al., at 12 weeks (end-of-treatment), the prolonged smoking abstinence rate was 40.0% in the varenicline group compared to 8.3% in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2962400/

Varenicline for smoking cessation: efficacy, safety, and ... The most commonly reported adverse events experienced by subjects on varenicline in clinical trials were nausea (28.1% versus 8.4% placebo), headache (15.5% ...

7. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-review-update-chantix-varenicline-and-risk-neuropsychiatric

Safety review update of Chantix (varenicline) and risk ... A prescription medicine used to help adults quit smoking · Increases the likelihood of abstinence from smoking for as long as one year compared ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2793375

Efficacy and Safety of Varenicline for Smoking Cessation in ... Throughout the trial, patients in the varenicline group were at least 3 times more likely to quit smoking compared with patients in the placebo ...

9. cdc.gov cdc.gov/tobacco/campaign/tips/quit-smoking/quit-smoking-medications/how-to-use-quit-smoking-medicines/how-to-use-varenicline.html

How to Use Varenicline | Quit Smoking All have been shown to be safe and effective for adults who smoke cigarettes. ... Text QUITNOW to 333888—Message and data rates may apply; quitSTART app ...