Varenicline + NRT for Smoking Cessation in PLWHA

(HTO Trial)

Recruiting at 1 trial location

Overseen By Robert Schnoll, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Pennsylvania

Must not be taking: Quit smoking medications

Disqualifiers: Substance abuse, Major depression, Psychosis, Bipolar, 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

Compensation: Varies

Number of Visits: 26

Duration: 24 weeks

340 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the most effective method to help individuals with HIV/AIDS quit smoking, as smoking can lead to cancer and heart problems. It evaluates various treatments, including a nicotine patch and the medication varenicline (also known as Chantix or Champix), combined with counseling. Participants will receive either varenicline with counseling or a personalized combination that includes problem-solving support. This trial suits individuals who smoke daily, have a confirmed HIV diagnosis, and live near the trial sites. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potential new treatment option.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use or have recently stopped using quit smoking medications within the last 14 days.

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

Research has shown that varenicline is generally safe for people with HIV who want to quit smoking, and it is as safe for them as it is for those without HIV. However, some individuals may experience side effects, which can sometimes lead to discontinuing the medication. Common side effects include nausea, trouble sleeping, and vivid dreams.

For the nicotine patch, research indicates it is generally safe and effective for adults. Some individuals might experience skin irritation where the patch is applied. Following the instructions can reduce the chance of these side effects.

Overall, studies have found both varenicline and nicotine patches to be safe. However, consulting a doctor is always advisable to determine the best option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer new approaches for helping people living with HIV/AIDS quit smoking. Unlike the standard nicotine replacement therapies, such as nicotine patches and gum, varenicline targets brain receptors directly involved in nicotine addiction, potentially reducing cravings more effectively. Additionally, the combination of either varenicline or nicotine patches with the Managed Problem Solving (MAPS) adherence intervention is designed to enhance treatment adherence, making it easier for patients to stick to their quitting plan. These innovative strategies could provide more effective solutions for smoking cessation in this specific population.

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

Research shows that varenicline helps people quit smoking. One study found that about 65% of participants stopped smoking after 12 weeks of using varenicline. In this trial, one group will receive varenicline plus standard cessation counseling. Another group will receive either varenicline or nicotine patches, combined with standard cessation counseling and a Managed Problem Solving (MAPS) adherence intervention. Varenicline has proven more effective than using nicotine replacement therapy (NRT) alone, such as nicotine patches. Nicotine patches can ease withdrawal symptoms and double the chances of quitting compared to a placebo, but they are less effective than varenicline when used alone. Combining varenicline with NRT might increase the chances of quitting, especially for smokers with other health issues. ^{6 7 8 9 10}

Who Is on the Research Team?

Robert Schnoll, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults over 18 who smoke daily, live near the study sites for at least 7 months, and can safely use varenicline or nicotine patches. Participants must be HIV positive with a viral load under 1000 copies/mL. Those with recent serious health issues, certain mental health conditions, or using other tobacco cessation methods cannot join.

Inclusion Criteria

I am over 18 years old.

You are living in the geographic area close to one of the sites for at least 7 months.

You have HIV and your viral load is less than 1000 copies/mL.

Exclusion Criteria

History of epilepsy or seizure disorder requires study physician approval

My high blood pressure is not under control.

I have had cancer, heart disease, stroke, or a heart attack in the last 6 months and need approval from the study doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive varenicline or nicotine patch plus standard behavioral smoking cessation treatment with Managed Problem Solving adherence intervention

24 weeks

Regular visits for adherence monitoring and counseling

Follow-up

Participants are monitored for smoking abstinence and health outcomes post-treatment

26 weeks

Outcome assessments at week 26

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine patch
• Standard treatment
• Standard treatment + Managed Problem Solving (MAPS) adherence intervention
• Varenicline

Trial Overview The study tests if adding Managed Problem Solving (MAPS) to standard treatment helps people living with HIV/AIDS quit smoking more effectively than just standard care alone. It also examines the effectiveness of Varenicline and nicotine patches in this specific group.

How Is the Trial Designed?

Group I: NMR-Tailored Medication & Standard Cessation Counseling + MAPS Experimental Treatment 3 Interventions

varenicline or nicotine patch plus standard behavioral smoking cessation treatment with Managed Problem Solving adherence intervention

Group II: Varenicline & Standard Cessation Counseling Active Control 2 Interventions

varenicline plus standard behavioral smoking cessation treatment

Nicotine patch is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Nicoderm for:

• Smoking cessation

Approved in European Union as Nicorette Patch for:

• Smoking cessation

Approved in Canada as NRT Patch for:

• Smoking cessation

Approved in Japan as Nicoderm for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

In a study involving 269 wart lesions treated with either a 0.5% podophyllotoxin cream or solution, both treatments significantly reduced wart size, with complete clearance achieved in 63% of patients in both groups after 8 weeks.

The study found no additional clinical benefits of using the cream formulation over the solution, as both had similar efficacy and side effects in treating external genital warts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-blind study of podophyllotoxin cream 0.5% and podophyllotoxin solution 0.5% in male patients with genital warts. Petersen, CS., Agner, T., Ottevanger, V., et al.[2019]

After the FDA issued warnings about neuropsychiatric side effects of varenicline, its use among veterans dropped significantly, decreasing from 6.2 to 1.0 per 1,000 smokers by July 2009, while nicotine replacement therapy (NRT) use increased, indicating a potential switch in treatment options.

Even after the FDA removed the warning in December 2016, varenicline prescribing did not return to pre-warning levels by December 2019, suggesting lasting impacts of the warnings on prescribing practices among veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in Incident Varenicline Prescribing Among Veterans Following the US Food and Drug Administration Drug Safety Warnings. Gerlach, LB., Van, T., Kim, HM., et al.[2023]

Topical cidofovir has been shown to be an effective treatment for non-genital warts, achieving clearance in 55.2% of patients, based on a review of 603 cases.

The treatment demonstrated a favorable safety profile, with only 17.4% of patients experiencing local side effects, and no recurrence of lesions reported within a follow-up period averaging 15.8 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cidofovir in the Management of Non-Genital Warts: A Review. Cook, MK., Hagen, EM., Feldman, SR.[2023]

Smoking cessation is crucial for health, and psychiatric nurses should actively support patients in using therapies like varenicline (Chantix) to quit smoking.

Recent research has raised safety concerns about varenicline, including its potential links to neuropsychiatric side effects, seizures, and interactions with alcohol, which clinicians need to consider when recommending this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. Tobin, TJ., Tobin, ML.[2018]

Interferon alpha is currently the only antiviral/immunomodulatory drug approved for treating genital warts, but it has limitations such as high cost, systemic side effects, and slow action.

New antiviral/immunomodulatory drugs like imiquimod and cidofovir show promise in effectively treating warts while also aiming to reduce the recurrence of HPV, addressing the shortcomings of existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic approaches to papillomavirus infections. Baker, GE., Tyring, SK.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. Biazzo, LL., Froshaug, DB., Harwell, TS., et al.[2015]

Intralesional cidofovir was administered to a renal transplant patient with numerous palmar warts, with seven injections given at four-week intervals, demonstrating its potential effectiveness in treating stubborn warts in immunocompromised individuals.

The results suggest that cidofovir could be a promising treatment option for cutaneous warts in patients with weakened immune systems, such as those who have undergone kidney transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intralesional cidofovir in the treatment of cutaneous warts in a renal transplant patient. Blouin, MM., Cloutier, R., Noël, R.[2018]

In a study involving 37 immunocompetent subjects, the nitric-zinc complex showed a 90% complete cure rate for external genital warts and difficult-to-treat warts after one to four applications, demonstrating its efficacy.

The treatment was well tolerated with no serious adverse events reported, indicating it is a safe option for patients suffering from these types of warts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of nitric-zinc complex in the treatment of external genital warts and "difficult-to-treat" warts: a "proof of concept", prospective, multicentre, open study. Cusini, M., Micali, G., Lacarrubba, F., et al.[2015]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8201739/

The effectiveness of the nicotine patch for smoking ... Active patch subjects were more than twice as likely to quit smoking as individuals wearing a placebo patch, and this effect was present at both high and low ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4410859/

Long-term Nicotine Replacement Therapy Third, nicotine patches are not the most effective pharmacotherapy for smoking cessation. Future studies should examine the possibility that long-term ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460397000415

A comparison of measures used to assess effectiveness ... The transdermal nicotine patch decreases nicotine withdrawal signs and symptoms and can double smoking cessation rates. The patch doubles abstinent rates after ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2809121

Adaptive Smoking Cessation Using Precessation ... A study on precessation varenicline found that responders showed a 2.95-fold higher smoking abstinence rate than non-responders. Regarding ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01622998

Self-directed Titrated Transdermal Nicotine Patch Versus ... The primary aim of this research study is to determine whether titrated, patient-directed transdermal patch NRT, based on smoking history and symptoms of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2917405/

Adverse events associated with nicotine replacement therapy ... Pooled evidence specific to the NRT patch found an increase in skin irritations (OR 2.80, 95% CO, 2.28-3.24, P < 0.001). Orally administered NRT was associated ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/nicotine-transdermal-route/description/drg-20068808

Nicotine (transdermal route) - Side effects & dosage Safety and efficacy have not been established. Small amounts of nicotine can cause serious unwanted effects in children, and patches contain ...

8. cdc.gov cdc.gov/tobacco/campaign/tips/quit-smoking/quit-smoking-medications/how-to-use-quit-smoking-medicines/how-to-use-a-nicotine-patch.html

How to Use Nicotine Patches | Quit Smoking They work in different ways. All have been shown to be safe and effective for adults who smoke cigarettes. These quit-smoking medicines include nicotine ...

9. nicorette.com nicorette.com/shop/patch/?srsltid=AfmBOoqPHT8yks9dKO_SPHwa3jphdjEdiuPibCArf8MRSf2sjvWKQJpt

NicoDerm CQ Nicotine Patches: Relief You Can Wear Buy NicoDerm CQ patches from Nicorette to help you quit smoking. You can wear these nicotine patches under your clothes to ease your cravings discreetly.

10. goodrx.com goodrx.com/health-topic/nicotine/nicotine-patch-side-effects?srsltid=AfmBOorR25DWHQTTjIKINUZIK_GBfBNxlKxwiVljupXSRzs7Kp0H2XP8

8 Nicotine Patch Side Effects and How to Manage Them Nicotine patches (Nicoderm CQ) are used to quit smoking and manage nicotine withdrawal symptoms. Here are nine nicotine patch side effects ...