Nicotine Patch for E-Cigarette Withdrawal

Overseen By Justin Strickland, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Johns Hopkins University

Must be taking: Nicotine e-cigarettes

Must not be taking: OTC medications

Disqualifiers: Psychoactive drugs, Cannabis, Psychiatric condition, others

Compensation: Varies

Number of Visits: 1

Duration: 1 week

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the effects of quitting e-cigarettes and how nicotine patches might alleviate withdrawal symptoms. Participants will be randomly assigned to receive a nicotine patch (transdermal nicotine patch), a placebo patch, or no patch. The study is ideal for individuals who have used nicotine e-cigarettes daily for at least six months and wish to reduce their usage. As an Early Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants a chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

The trial requires that you do not use any over-the-counter or prescription medications that may impact safety. It's best to discuss your current medications with the study team to see if they are allowed.

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

Research has shown that nicotine patches are generally safe to use. The FDA has approved them to help people quit smoking, indicating they have undergone safety testing in humans. Some individuals might experience mild side effects, such as skin irritation at the application site. Serious side effects are rare but possible. Following the instructions for correct use is important to reduce risks. While nicotine patches help manage withdrawal symptoms, they should be used as directed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for e-cigarette withdrawal?

Researchers are excited about these treatments because they are exploring the use of nicotine patches to help with e-cigarette withdrawal, offering a potential new approach for those trying to quit vaping. Unlike most treatments that focus on behavioral support or medications targeting nicotine receptors in the brain, this trial tests a transdermal nicotine patch. This delivery method allows a controlled release of nicotine through the skin, which may reduce withdrawal symptoms more steadily and comfortably than other cessation aids like gum or lozenges. Additionally, by comparing the effects of a placebo patch, researchers hope to better understand the patch's true effectiveness, which could lead to more reliable quitting strategies for e-cigarette users.

What evidence suggests that the Transdermal Nicotine Patch could be effective for e-cigarette withdrawal?

Research has shown that nicotine replacement therapy (NRT), such as the nicotine patch, can help manage cravings and withdrawal symptoms. In this trial, participants may receive a Transdermal Nicotine Patch, which delivers a steady amount of nicotine through the skin to reduce the urge to smoke or vape. Studies have found that nicotine patches can more than double the chances of staying smoke-free for a year compared to a placebo. Although e-cigarettes have sometimes proven more effective than patches, patches remain a proven method for quitting nicotine products. This makes them a valuable option for those looking to quit e-cigarettes. ^{5 6 7 8 9}

Who Is on the Research Team?

Justin Strickland, Ph.D.

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults aged 21-55 who use e-cigarettes daily, have a mild or greater dependence on nicotine, and are in good health. Participants must not be using other tobacco products or cessation aids, have no major medical or psychiatric conditions that could affect their safety, and should not be pregnant.

Inclusion Criteria

You have been vaping with a nicotine-containing e-cigarette for at least 6 months on a daily basis.

You display a mild to severe degree of dependence on e-cigarettes, as indicated by your Penn State E-cigarette Dependence score.

Your exhaled breath carbon monoxide level is less than 6 parts per million.

Exclusion Criteria

You have used drugs that affect your mind (except for cannabis, nicotine, alcohol, and caffeine) within the past month.

You use cannabis more than twice a week.

I am taking medications that could affect my safety in the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo monitored e-cigarette abstinence over seven days in a residential unit, with evaluation of withdrawal symptoms and the role of nicotine using different patch conditions.

1 week

Daily monitoring in a residential unit

Follow-up

Participants are monitored for return to e-cigarette use and withdrawal symptoms after the residential stay.

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Nicotine Patch
• Transdermal Nicotine Patch

Trial Overview The study aims to understand withdrawal symptoms in exclusive e-cigarette users by comparing the effects of a transdermal nicotine patch versus a placebo patch during an abstinence period.

How Is the Trial Designed?

Group I: Transdermal Nicotine Patch Experimental Treatment 1 Intervention

Participants assigned to this condition will receive a blinded nicotine patch and will wear the patch on their upper arm, per the manufacturer's instructions.

Group II: No Patch Active Control 1 Intervention

Participants assigned to this condition will not receive a patch.

Group III: Transdermal Placebo Patch Placebo Group 1 Intervention

Participants assigned to this placebo nicotine patch condition will receive a blinded patch containing 0mg of nicotine, and will wear the patch on their upper arm, per the manufacturer's instructions.

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

Approved in United States as Nicotine Patch for:

• Smoking cessation
• Nicotine dependence

Approved in Canada as Nicotine Patch for:

• Smoking cessation
• Nicotine dependence

Approved in European Union as Nicotine Patch for:

• Smoking cessation
• Nicotine dependence

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

High-dose transdermal nicotine-replacement therapy (NRT) at doses of 42 mg or more daily appears to be safe, with most trials reporting no serious adverse events, although a dose-response relationship for adverse events was noted.

While high-dose NRT showed a numerically higher abstinence rate in most trials, none achieved statistically significant differences in final abstinence rates, indicating that more extensive studies are needed to confirm its efficacy and identify suitable patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose transdermal nicotine replacement for tobacco cessation. Brokowski, L., Chen, J., Tanner, S.[2019]

Nicotine replacement therapy (NRT) is an effective treatment for nicotine dependence, with various formulations available over-the-counter in several European countries.

The most commonly used NRT products, such as nicotine chewing gum and transdermal patches, have been proven safe and effective in population studies across different countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nicotine replacement therapy--method for smoking cessation]. Florek, E., Piekoszewski, W.[2017]

In a study of 158 smokers, transdermal nicotine patches significantly improved smoking cessation rates, with 39% of participants using 24-hour patches and 35% using patches during wakeful hours achieving abstinence, compared to only 13.5% in the placebo group.

The nicotine patches also effectively reduced tobacco withdrawal symptoms during the initial weeks of quitting, demonstrating their safety and efficacy as an adjunct to low-intervention therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of transdermal nicotine as an adjunct in smoking cessation therapy. A double-blind randomized study controlled with placebo]. Daughton, DM., Heatley, SA., Prendergast, JJ., et al.[2015]

In a 3-month study involving 199 participants, the transdermal nicotine patch significantly increased smoking abstinence rates compared to placebo, with 41% of the nicotine group abstinent at 1 month versus 19% in the placebo group.

The nicotine patch was well tolerated overall, with minimal weight gain in the nicotine group compared to a significant weight increase in the placebo group, although some participants experienced local skin reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled trial of transdermal nicotine patch in tobacco withdrawal. Abelin, T., Buehler, A., Müller, P., et al.[2022]

Transdermal nicotine patches can effectively help people quit smoking by providing a steady release of nicotine, which alleviates withdrawal symptoms like cravings and irritability.

In clinical trials, these nicotine patches have shown to be about twice as effective as placebo in aiding smoking cessation, highlighting their efficacy as a supportive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermal nicotine replacement and smoking cessation. McKenna, JP., Cox, JL.[2017]

In a study of 112 young, nicotine-dependent smokers, those using a transdermal nicotine system (TNS) had a significantly higher abstinence rate of 39.3% compared to 19.6% in the placebo group after nine weeks, indicating the efficacy of TNS in aiding tobacco withdrawal.

While TNS users experienced some reduction in withdrawal symptoms like tension and difficulty concentrating, the treatment was associated with mild skin reactions at the application site in 20% of users, suggesting that while TNS is effective, it may cause some localized side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Weaning of young smokers using a transdermal nicotine patch]. Ehrsam, RE., Bühler, A., Müller, P., et al.[2022]

In a study of 158 smokers, transdermal nicotine patches significantly improved smoking cessation rates, with 39% of participants using 24-hour patches and 35% using patches during wakeful hours achieving abstinence, compared to only 13.5% in the placebo group.

The nicotine patches also effectively reduced tobacco withdrawal symptoms during the initial weeks of quitting, demonstrating their safety and efficacy as an adjunct to low-intervention therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transdermal nicotine delivery as an adjunct to low-intervention smoking cessation therapy. A randomized, placebo-controlled, double-blind study. Daughton, DM., Heatley, SA., Prendergast, JJ., et al.[2017]

Nicotine replacement therapy using a transdermal patch significantly increased the smoking cessation rate to 77% compared to 39% in the placebo group over 6 weeks, indicating its efficacy for heavy smokers.

While most participants experienced mild skin reactions from the nicotine patches, the high compliance rates suggest that the therapy is generally safe and well-tolerated, though additional behavioral support is necessary to prevent relapse after the initial treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine-replacement therapy with use of a transdermal nicotine patch--a randomized double-blind placebo-controlled trial. Hurt, RD., Lauger, GG., Offord, KP., et al.[2019]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK493148/

Nicotine Replacement Therapy - StatPearls - NCBI Bookshelf NRTs are designed to replicate the nicotine response typically experienced through smoking, thereby helping individuals manage cravings and withdrawal symptoms.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9117131/

Electronic cigarettes versus nicotine patches for smoking ... When abstinent participants using non-allocated products were excluded, e-cigarettes were markedly more effective than patches in all abstinence ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1326020023015248

Ten‐year survival outcome of the nicotine transdermal ... It has been shown to produce more than double 12‐month sustained abstinence after quitting compared with placebo.

4. 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 The nicotine patch is an FDA-approved medicine that can help people quit smoking. It can be used daily by itself to control withdrawal symptoms, or it may be ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06832098

Study Details | NCT06832098 | Nicotine Patch Plus ... The effectiveness of combination nicotine replacement therapy (NRT) compared to nicotine tapering on vaping abstinence has not yet been investigated, but both ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213260019302693

Nicotine patches used in combination with e-cigarettes ... 35 (7%) participants in the patches plus nicotine e-cigarette group had CO-verified continuous abstinence at 6 months compared with 20 (4%) in the patches plus ...

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. amjmed.com amjmed.com/article/S0002-9343(23)00295-4/fulltext

Efficacy and Safety of E-Cigarette Use for Smoking Cessation Overall, these data suggest e-cigarettes appear to be more efficacious than conventional nicotine replacement or behavioral smoking cessation ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6398670/

Effectiveness and safety of nicotine patches combined with ... A 6 month quit rate of 23% for the nicotine patch + nicotine free e-cigarette group was assumed, based on a pragmatic trial (n=1410) undertaken ...