What side effects are associated with this type of intervention?

Common treatments for nicotine delivery through oral mucosa, such as nicotine pouches, gum, and lozenges, often have side effects that include mouth and throat irritation, hiccups, nausea, and heartburn. Users may also experience increased salivation and a burning sensation in the mouth. These side effects are generally mild and tend to diminish with continued use. However, more severe reactions like persistent mouth ulcers or allergic reactions, though rare, may require discontinuation and consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several nicotine replacement therapies (NRT) for the treatment of nicotine dependence, which deliver nicotine through the oral mucosa. These include nicotine gums, lozenges, and sublingual tablets. These products are designed to help individuals quit smoking by reducing withdrawal symptoms and cravings. The approval of these therapies is based on their ability to provide a controlled dose of nicotine without the harmful effects of tobacco smoke.

What other types of research exist?

Promising alternatives to tobacco-free oral nicotine pouches for nicotine delivery include: 1) Electronic cigarettes (e-cigarettes), which have shown efficacy in smoking cessation in randomized controlled trials. 2) Nicotine replacement therapies such as nicotine patches, gums, and lozenges, which are well-established and effective. 3) Mobile phone-based interventions and smartphone apps, which provide behavioral support and have shown promise in aiding smoking cessation. Combining these alternatives with behavioral support can enhance their effectiveness.

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Nicotine Replacement Therapy

Oral Nicotine Pouches for Tobacco Use Disorder

Phase 1

Recruiting

Led By Tory Spindle, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-report at least a one year history of regular smoking

Exhaled breath CO greater than or equal to 10ppm and urine cotinine greater than 100 ng/ml at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6.5 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how healthy adult smokers respond to tobacco-free oral nicotine pouches. The pouches come in various flavors and strengths, and the study measures how the body absorbs and reacts to the nicotine, including effects on withdrawal symptoms and vital signs. Tobacco-free oral nicotine pouch products have emerged as a potential reduced risk product compared with cigarettes and other tobacco products.

Who is the study for?

This trial is for healthy adult smokers who smoke daily, have a mild tobacco use disorder, and haven't used other tobacco products or nicotine pouches recently. They must be over 21 years old with normal vital signs and no recent drug use (except THC). Pregnant women, those in another trial within the last month, or using certain medications are excluded.

What is being tested?

The study tests 'tobacco-free' oral nicotine pouches of different flavors and doses against regular cigarettes to see how they affect the body and cravings. Participants will try each product under controlled conditions first, then freely for two hours in a double-blind setup.

What are the potential side effects?

Possible side effects may include typical nicotine-related symptoms such as increased heart rate, nausea, headache, dizziness, dry mouth or throat irritation from the pouches. Smoking cigarettes carries well-known risks like lung damage and cancer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been smoking regularly for at least one year.

Select...

My breath and urine tests show high levels of nicotine.

Select...

I am 21 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6.5 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6.5 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6.5 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pharmacokinetics of nicotine as assessed by the AUC

Pharmacokinetics of nicotine as assessed by the Cmax

Subjective ratings of "Like Drug Effect" as assessed by the Drug Effect Questionnaire

+4 more

Secondary study objectives

Negative and aversive effects as assessed by the Drug Effect Questionnaire

Perceived strength of effects as assessed by the Drug Effect Questionnaire

Pharmacokinetics of nicotine as assessed by the Tmax

+4 more

Side effects data

From 2014 Phase 4 trial • 127 Patients • NCT01400243

65%

Any nonserious adverse event

22%

Itchiness at Patch Site

16%

Nausea

Redness at patch site

Headache

Decreased appetite

Lucid dreams

Hot or sweating

Lightheadedness

100%

80%

60%

40%

20%

Study treatment Arm

Nicotine Patch

Placebo Patch

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: Original/Tobacco Flavored Pouch (low nicotine dose)Experimental Treatment1 Intervention

participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions

Group II: Original/Tobacco Flavored Pouch (high nicotine dose)Experimental Treatment1 Intervention

participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions

Group III: Mint/Menthol Flavored Pouch (low nicotine dose)Experimental Treatment1 Intervention

participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions

Group IV: Mint/Menthol Flavored Pouch (high nicotine dose)Experimental Treatment1 Intervention

participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions

Group V: Fruit Flavored Pouch (low nicotine dose)Experimental Treatment1 Intervention

participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions

Group VI: Fruit Flavored Pouch (high nicotine dose)Experimental Treatment1 Intervention

participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions

Group VII: Own brand cigarettesActive Control1 Intervention

participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Nicotine replacement therapies (NRT) work by delivering nicotine to the body without the harmful chemicals found in tobacco smoke. This helps to reduce withdrawal symptoms and cravings associated with quitting smoking. Oral nicotine pouches, similar to other NRTs, deliver nicotine through the oral mucosa, providing a controlled dose that can help manage addiction. This method is particularly beneficial as it mimics the rapid nicotine delivery of smoking, aiding in the transition away from cigarettes. For patients, understanding these mechanisms is crucial as it highlights the effectiveness of NRTs in reducing dependence on tobacco, thereby lowering the risk of smoking-related diseases.

Effectiveness of dentist's intervention in smoking cessation: A review.Interventions for tobacco cessation in the dental setting.A randomized placebo-controlled clinical trial of 5 smoking cessation pharmacotherapies.