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

Trial Summary

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.

What data supports the effectiveness of the drug Varenicline for quitting smoking?

Research shows that Varenicline, when combined with counseling, helps people quit smoking more effectively than using nicotine patches or another drug called bupropion. It works by reducing cravings and withdrawal symptoms, making it easier for people to stop smoking. ^{1 2 3 4 5}

Is varenicline safe for humans?

Varenicline is generally considered safe for helping people quit smoking, but it may cause some side effects like sleep disorders and has been linked to changes in mood or behavior. While some studies suggested a slight increase in heart-related issues, most research found no significant risk, and it is well tolerated in healthy adults and those with stable heart conditions. ^{3 6 7 8 9}

How does the drug varenicline differ from other smoking cessation treatments?

Varenicline is unique because it is the first non-nicotine medication specifically developed to treat nicotine addiction by targeting specific receptors in the brain to reduce cravings and withdrawal symptoms. It has been shown to be more effective than other treatments like nicotine patches or bupropion, and it can be used with flexible dosing and quit dates to improve its effectiveness. ^{1 2 3 8 10}

What is the purpose of this trial?

The purpose of the RECLAIM study is to evaluate the effectiveness of varenicline (sometimes known as Chantix) compared to placebo (an inactive substance) for the treatment of cigarettes and cannabis (marijuana). Varenicline is not FDA approved for the combination treatment of cigarette abstinence and cannabis reduction or abstinence. All participants will also receive counseling and access to online treatment modules during a quit attempt for cigarettes and a reduction attempt for cannabis. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed. To qualify, participants must be 18 or older, live in South Carolina, use cigarettes and cannabis, and are interested in quitting cigarettes and reducing cannabis.

Research Team

Erin Mcclure

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[On oral medications, especially varenicline]. [2015]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Varenicline in smoking cessation. [2017]

4. United States 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. [2023]

5. England 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. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Extended varenicline treatment in a severe cardiopathic cigarette smoker: a case report. [2018]

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

Safety and effectiveness of varenicline in a veteran population with a high prevalence of mental illness. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Varenicline for smoking cessation. [2015]

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

Varenicline and cardiovascular adverse events: a perspective review. [2021]

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

Varenicline: mode of action, efficacy, safety and accumulated experience salient for clinical populations. [2021]