Varenicline + Counseling for Quitting Smoking

(RECLAIM Trial)

Overseen By Elizabeth Chapman

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Medical University of South Carolina

Must not be taking: Smoking cessation medications

Disqualifiers: Unstable medical, psychiatric, pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests varenicline, also known as Chantix, to determine its effectiveness in helping people quit smoking cigarettes and reduce cannabis use. Participants will be randomly assigned to receive either varenicline or a placebo (an inactive substance) and will also receive counseling and access to online treatment resources. The trial aims to assess varenicline's effectiveness for individuals trying to quit cigarettes and reduce cannabis use. Suitable candidates include those living in South Carolina who smoke at least five cigarettes a day, use cannabis regularly, and are interested in quitting smoking and reducing cannabis use. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to significant research on a potentially effective treatment.

Will I have to stop taking my current medications?

The trial requires that you do not use medications that help with quitting smoking. If you're on such medications, you may need to stop them to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that varenicline, also known as Chantix, has been studied for its safety in helping people quit smoking. In these studies, the most common side effects included nausea and headaches. About 28% of people taking varenicline experienced nausea, compared to 8% of those taking a placebo. Headaches were reported by about 15% of those on varenicline.

Although these side effects were noted, they are generally manageable. Varenicline has been used to help people stop smoking and is usually well-tolerated by many. However, not everyone will have the same experience, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard smoking cessation treatments like nicotine replacement therapy or bupropion, varenicline works by targeting the brain's nicotine receptors directly, reducing cravings and withdrawal symptoms. This unique mechanism of action helps decrease the pleasure derived from smoking, making it easier for individuals to quit. Researchers are excited about varenicline because it has shown higher quit rates compared to other options, offering a promising alternative for those struggling to give up smoking.

What evidence suggests that varenicline could be an effective treatment for quitting smoking and reducing cannabis use?

Research has shown that varenicline, which participants in this trial may receive, effectively helps people quit smoking. One study found that about 40% of people using varenicline stopped smoking after 12 weeks, compared to only 8.3% of those taking a placebo. Another study discovered that using varenicline for 24 weeks instead of 12 weeks reduces the chance of starting to smoke again. Varenicline has been proven to help people remain smoke-free for up to a year, making it a strong aid for quitting smoking. Although not yet approved for reducing cannabis use, its success in helping people quit smoking suggests it might be helpful. ^{4 6 7 8 9}

Who Is on the Research Team?

Erin Mcclure

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults in South Carolina who smoke at least 5 cigarettes daily and use cannabis at least 3 days a week. They must want to quit smoking and are open to reducing or stopping cannabis use. Participants will be tested for tobacco and cannabis use before joining.

Inclusion Criteria

I live in South Carolina.

I have tested positive for nicotine and cannabis use.

I have smoked at least 5 cigarettes daily for most days in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive varenicline or placebo along with psychosocial intervention for cigarette abstinence and cannabis reduction

12 weeks

All procedures conducted remotely

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Varenicline

Trial Overview The RECLAIM study tests if Varenicline (Chantix) helps people stop smoking cigarettes and reduce or quit using cannabis, compared to a placebo. Everyone gets counseling and online modules aimed at quitting smoking and cutting down on cannabis.

How Is the Trial Designed?

Group I: Varenicline Experimental Treatment 3 Interventions

Participants will be randomized 1:1 to varenicline or matched placebo. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1 mg b.i.d. starting on Day 8. Dosing of 2 mg per day will be maintained for the next 11 weeks.

Group II: Placebo Placebo Group 2 Interventions

Participants will be randomized 1:1 to varenicline or matched placebo.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 1027 adult smokers, varenicline was found to be significantly more effective for smoking cessation than both placebo and bupropion SR, with 43.9% of participants abstinent during the last 4 weeks of treatment compared to 17.6% and 29.8% respectively.

Varenicline was generally safe and well-tolerated, with the most common side effect being nausea, affecting 29.4% of participants, and a discontinuation rate due to adverse events similar to that of bupropion SR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. Jorenby, DE., Hays, JT., Rigotti, NA., et al.[2023]

Varenicline is an effective treatment for tobacco addiction, showing improved quit rates compared to other therapies, and is safe for use in both healthy smokers and those with cardiovascular or pulmonary issues, as well as smokeless tobacco users.

While varenicline is generally well-tolerated, there have been concerns about potential neuropsychiatric side effects, leading to updated monitoring guidelines, although most studies did not find a significant link to serious psychiatric symptoms, except for sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline in smoking cessation. Tonstad, S., Rollema, H.[2017]

A case study of a 52-year-old man with cardiovascular disease showed that varenicline was safely used for 9 months to help him quit smoking, demonstrating its potential effectiveness in high-risk patients.

The combination of varenicline and intensive behavioral counseling not only helped the patient achieve smoking abstinence but also highlighted the importance of promoting smoking cessation in individuals with cardiovascular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended varenicline treatment in a severe cardiopathic cigarette smoker: a case report. Munarini, E., Marabelli, C., Pozzi, P., et al.[2018]

In a study of 139 long-term nicotine replacement therapy users, varenicline combined with counseling significantly improved the quit rate at 12 weeks (64.3% for varenicline vs. 40.6% for placebo), indicating its efficacy in helping users stop NRT.

Participants taking varenicline experienced lower withdrawal symptoms compared to those on placebo, suggesting that varenicline not only aids in quitting but also makes the process more comfortable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline to stop long-term nicotine replacement use: a double-blind, randomized, placebo-controlled trial. Tønnesen, P., Mikkelsen, K.[2015]

Varenicline is an effective first-line smoking cessation aid, but its safety profile regarding serious cardiovascular events has been debated, with some reviews suggesting a nominally higher risk compared to placebo.

Despite some evidence indicating that serious cardiovascular risks may not be significantly increased with varenicline, the FDA recommends cautious prescribing and close monitoring, especially for patients with unstable cardiac conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline and cardiovascular adverse events: a perspective review. Chelladurai, Y., Singh, S.[2021]

In a study of 50 veterans using varenicline for smoking cessation, only 30% successfully quit smoking, which is lower than the 44% success rate reported in premarketing studies.

The study found a significant association between underlying psychiatric disorders and treatment failure, with all patients who discontinued due to adverse drug events related to mood changes having a history of mental illness, highlighting the need for careful monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of varenicline in a veteran population with a high prevalence of mental illness. Purvis, TL., Mambourg, SE., Balvanz, TM., et al.[2015]

In a study involving 392 adult patients admitted for smoking-related illnesses, those who received varenicline tartrate along with Quitline-counselling had a significantly higher rate of continuous smoking abstinence (31.1%) compared to those who received counselling alone (21.4%).

The results suggest that initiating varenicline treatment in the inpatient setting, combined with counselling, is an effective strategy for promoting long-term smoking cessation, with benefits observed at a 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Termination Opportunity for inPatients (STOP): superiority of a course of varenicline tartrate plus counselling over counselling alone for smoking cessation: a 12-month randomised controlled trial for inpatients. Smith, BJ., Carson, KV., Brinn, MP., et al.[2015]

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/jamanetworkopen/fullarticle/2820435

Varenicline and Nicotine Replacement Therapy for ... Varenicline is the most effective sole pharmacotherapy for smoking cessation and is as effective as combination nicotine replacement therapy ...

3. 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 ...

4. tobaccopreventioncessation.com tobaccopreventioncessation.com/Cue-restricted-smoking-increases-quit-rates-with-varenicline,133570,0,2.html

Cue restricted smoking increases quit rates with varenicline When we evaluated only smokers that used varenicline in monotherapy, 75% (92/122) of the CRS group reached the primary outcome, while 42% (87/ ...

5. pfizer.com pfizer.com/news/press-release/press-release-detail/chantix_champix_varenicline_demonstrates_smoking_cessation_efficacy_in_smokers_unwilling_or_unable_to_quit_abruptly

CHANTIX®/CHAMPIX® (varenicline) Demonstrates Smoking CHANTIX has been shown to increase the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo. Adults ...

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 ... Increases the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo. Works by blocking the effects of ...

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 Varenicline is a pill you take twice a day. You start taking it at least one week before you quit, gradually increasing the dose.