Varenicline + PSF-M for Smoking Cessation in HIV/AIDS

Recruiting at 3 trial locations

Overseen By Yamila L Sierra, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Massachusetts General Hospital

Must be taking: Varenicline

Must not be taking: Antipsychotics

Disqualifiers: Pregnancy, Breastfeeding, Liver failure, others

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

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with HIV quit smoking by testing two approaches: varenicline, a smoking cessation aid, and a mobile behavioral program called Positively Smoke Free - Mobile. Participants will receive either standard care advice or the combination of varenicline and the mobile program. Individuals with HIV who currently smoke and wish to quit may be suitable for this trial. As a Phase 3 trial, this study serves as the final step before potential FDA approval, allowing participants to contribute to the validation of an effective treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must be able to use varenicline safely, which will be evaluated by your primary provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that varenicline, a medication to help people quit smoking, is generally safe for individuals with and without HIV. However, some may experience side effects that occasionally lead to discontinuing the treatment. The FDA has updated varenicline's label to include possible interactions with alcohol and some rare risks.

The Positively Smoke Free - Mobile (PSF-M) program is a mobile app designed to help people with HIV quit smoking. Although specific safety data for the app is unavailable, as a behavioral program, it is typically considered low risk.

Overall, varenicline has a well-documented safety record, and the mobile app is likely low-risk. Consulting a healthcare provider is essential to understand what this means personally. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Varenicline + Positively Smoke Free - Mobile because it combines a proven smoking cessation medication with a personalized mobile support program. Varenicline works by targeting nicotine receptors in the brain, reducing cravings and withdrawal symptoms, making it a powerful tool for quitting smoking. The Positively Smoke Free Mobile component offers tailored support through a mobile app, providing 42 days of content customized to each individual's quit date, which could enhance motivation and adherence. This dual approach not only addresses the physical addiction to nicotine but also offers ongoing behavioral support, distinguishing it from traditional methods like nicotine replacement therapies or standard counseling.

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

Research has shown that varenicline, a medication often used to help people quit smoking, is effective. In one study, about 28% of participants with HIV quit smoking after using varenicline. Another study found that varenicline increased the chances of quitting successfully. In this trial, some participants will receive varenicline alongside the Positively Smoke Free - Mobile (PSF-M) program, a smartphone tool designed to help people quit smoking, especially those with HIV. This program provides personalized support and has been studied for its potential to improve quitting success. Together, these treatments show promise in helping individuals with HIV stop smoking. ^{4 6 7 8 9}

Who Is on the Research Team?

Gina Kruse, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults over 18 with HIV who smoke tobacco, have a viral load under 1000 copies/mL, and CD4 count above 200 cells/mm3. They must read at a 6th-grade level in Tamil, Telugu or English and can safely use varenicline. Women must agree to contraception during the study.

Inclusion Criteria

You have recently been diagnosed with HIV, your viral load is below 1000 copies/mL and your CD4 count is above 200 cells/mm3.

You are a current smoker or dual tobacco user, confirmed by exhaled carbon monoxide of 7 parts per million or higher.

You are able to read and converse fluently in Tamil, Telugu or English at a minimum of 6th grade competency.

Exclusion Criteria

I have had a heart attack or unstable chest pain in the last 30 days.

My liver enzymes are high or my kidney function is low.

I have a history of psychosis or am taking anti-psychotic medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Varenicline and Positively Smoke Free-Mobile intervention

12 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for tobacco abstinence and safety

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Positively Smoke Free Mobile (PSF-M)
• Standard Care
• Varenicline

Trial Overview The study tests an intervention to help people with HIV quit smoking using PSF-M (a mobile behavioral program) and Varenicline (a medication). Participants will receive either this combination or standard care to see which helps more with quitting.

How Is the Trial Designed?

Group I: Varenicline + Positively Smoke Free - Mobile Experimental Treatment 2 Interventions

Offer of varenicline per package dosing with dose escalation over week 1: 0.5 mg once daily on days 1 - 3, 0.5 mg twice daily on days 4 -7, followed by 1.0 mg twice daily on days 8 to 84. Offer of Positively Smoke Free Mobile delivered by mobile phone including 42 days of content, tailored to individual quit date.

Group II: Standard Care Active Control 1 Intervention

Brief advice to quit tobacco Offer of referral to the national tobacco quitline

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a pilot study involving 36 HIV-infected smokers, varenicline was found to be safe and effective for smoking cessation, with a 42% rate of verified continuous abstinence over 4 weeks.

The treatment did not adversely affect HIV viral load, and CD4 counts increased significantly, indicating that varenicline can be a viable option for smoking cessation in this population, despite common side effects like nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of varenicline tartrate (Champix(®)/Chantix(®)) for smoking cessation in HIV-infected subjects: a pilot open-label study. Cui, Q., Robinson, L., Elston, D., et al.[2021]

Varenicline, when used for smoking cessation in HIV-infected individuals, has a safety profile similar to that observed in non-HIV smokers, with common side effects including nausea and sleep problems, but no significant cardiovascular issues reported.

Preliminary results indicate that varenicline is more effective than nicotine replacement therapy (NRT) for promoting smoking abstinence, with a confirmed abstinence rate of 25.6% in the varenicline group compared to 11.8% in the NRT group, suggesting that varenicline could be a preferred treatment option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of varenicline among smokers enrolled in the lung HIV study. Ferketich, AK., Diaz, P., Browning, KK., et al.[2021]

In a study of 47 daily smokers, those taking varenicline showed slower relapse rates and higher total abstinence after experiencing a programmed smoking lapse compared to those on a placebo.

Varenicline appears to reduce the perceived reward and effects of smoking, which may help prevent relapse during quit attempts, highlighting its effectiveness as a smoking cessation aid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of varenicline on abstinence and smoking reward following a programmed lapse. McClure, EA., Vandrey, RG., Johnson, MW., et al.[2021]

In a clinical trial involving 179 people living with HIV/AIDS, varenicline significantly increased smoking cessation rates at Week 12 compared to placebo, with 28.1% of participants quitting versus 12.1%.

Varenicline was found to be safe, with no significant differences in treatment-related side effects or adverse events compared to placebo, making it a viable option for short-term smoking cessation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo-controlled randomized clinical trial testing the efficacy and safety of varenicline for smokers with HIV. Ashare, RL., Thompson, M., Serrano, K., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of nicotine dependence with Chantix (varenicline). Rankin, KV., Jones, DL.[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 involving 248 people living with HIV, varenicline combined with counseling significantly increased the rate of smoking cessation compared to placebo, with 15% of participants in the varenicline group achieving continuous abstinence from weeks 9 to 48.

The safety profile of varenicline was favorable, showing a lower incidence of depression in the varenicline group (2%) compared to the placebo group (10%), indicating that varenicline is a safe and effective option for smoking cessation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of varenicline for smoking cessation in people living with HIV in France (ANRS 144 Inter-ACTIV): a randomised controlled phase 3 clinical trial. Mercié, P., Arsandaux, J., Katlama, C., et al.[2018]

In a study of 179 people living with HIV/AIDS, quitting smoking did not negatively impact adherence to anti-retroviral therapy (ART), which remained above 98% for all participants.

Participants who successfully quit smoking reported significant reductions in depression and anxiety symptoms, along with increased life satisfaction, suggesting that smoking cessation can have positive psychological effects for individuals with HIV/AIDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved clinical outcomes among persons with HIV who quit smoking. Lubitz, SF., Flitter, A., Ashare, RL., et al.[2021]

In a review of ten randomized controlled trials involving 3091 participants, varenicline did not show a significant increase in overall psychiatric disorders compared to placebo, with an incidence of 10.7% in the varenicline group versus 9.7% in the placebo group.

While varenicline was associated with a higher incidence of sleep disorders, there were no reported cases of suicidal ideation or behavior in the analyzed studies, suggesting that varenicline is generally safe for smokers without current psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis. Tonstad, S., Davies, S., Flammer, M., et al.[2022]

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