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

Trial Summary

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.

What data supports the effectiveness of the nicotine patch treatment for e-cigarette withdrawal?

Research shows that nicotine patches significantly help people quit smoking by reducing withdrawal symptoms and increasing quit rates compared to a placebo. In several studies, more people using nicotine patches stopped smoking than those using a placebo, and the patches were generally well tolerated. ^{1 2 3 4 5}

Is the nicotine patch safe for humans?

The nicotine patch is generally safe for humans, with most side effects being mild, such as skin reactions at the application site. Some people may experience mild, temporary systemic side effects, but these rarely lead to stopping the treatment. ^{2 4 5 6 7}

How does the nicotine patch treatment for e-cigarette withdrawal differ from other treatments?

The nicotine patch is unique because it delivers a steady dose of nicotine through the skin, helping to reduce withdrawal symptoms like cravings and irritability, which can be more effective than placebo treatments. This method is similar to its use in smoking cessation, where it has been shown to significantly improve quit rates compared to placebo. ^{1 2 3 5 8}

What is the purpose of this trial?

The goal of this project is to rigorously evaluate the nature of e-cigarette withdrawal in exclusive e-cigarette users during a monitored abstinence period and the role of nicotine in the expression of this withdrawal syndrome.

Research Team

Justin Strickland, Ph.D.

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

[Effects of transdermal nicotine as an adjunct in smoking cessation therapy. A double-blind randomized study controlled with placebo]. [2015]

2. Switzerland pubmed.ncbi.nlm.nih.gov

[Weaning of young smokers using a transdermal nicotine patch]. [2022]

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

Controlled trial of transdermal nicotine patch in tobacco withdrawal. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Nicotine-replacement therapy with use of a transdermal nicotine patch--a randomized double-blind placebo-controlled trial. [2019]

5. United States 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. [2017]

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

High-dose transdermal nicotine replacement for tobacco cessation. [2019]

7. Poland pubmed.ncbi.nlm.nih.gov

[Nicotine replacement therapy--method for smoking cessation]. [2017]

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

Transdermal nicotine replacement and smoking cessation. [2017]