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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

Study Summary

This trial is testing the effects of different doses and flavors of "tobacco-free" oral nicotine pouches on healthy smokers. The study uses a within-subjects, double-blind design, meaning that each participant uses each product once and that neither the participants nor the researchers know which product the participants are using during each session.

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.Check my eligibility
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.See study design
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
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I have been smoking regularly for at least one year.
Select...
My breath and urine tests show high levels of nicotine.
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I am 21 years old or older.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
8%
Redness at patch site
5%
Headache
5%
Decreased appetite
2%
Lucid dreams
2%
Hot or sweating
2%
Lightheadedness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nicotine Patch
Placebo Patch

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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,724 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,468 Previous Clinical Trials
2,619,292 Total Patients Enrolled
Tory Spindle, PhDPrincipal InvestigatorJohns Hopkins University
5 Previous Clinical Trials
328 Total Patients Enrolled

Media Library

Nicotine (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05335915 — Phase 1
Drug Effects Research Study Groups: Fruit Flavored Pouch (low nicotine dose), Fruit Flavored Pouch (high nicotine dose), Own brand cigarettes, Original/Tobacco Flavored Pouch (low nicotine dose), Original/Tobacco Flavored Pouch (high nicotine dose), Mint/Menthol Flavored Pouch (low nicotine dose), Mint/Menthol Flavored Pouch (high nicotine dose)
Drug Effects Clinical Trial 2023: Nicotine Highlights & Side Effects. Trial Name: NCT05335915 — Phase 1
Nicotine (Nicotine Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05335915 — Phase 1
Drug Effects Patient Testimony for trial: Trial Name: NCT05335915 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are researchers attempting to elucidate through this investigation?

"This medical study, which will last up to 6.5 hours, seeks to evaluate the subjective effects of a drug through a Drug Effect Questionnaire. Additionally, The Direct Effects of Nicotine Scale (DENS) and Tobacco Withdrawal Symptoms as Assessed by Tiffany-Drobes QSU Brief-Factor 2 shall also be evaluated. Pharmacokinetics is assessed via Tmax in order to determine time taken for maximum concentration level achieved."

Answered by AI

Is this clinical trial currently accepting participants?

"Affirmative. According to the clinicaltrials.gov database, this research is now seeking participants. It was first posted on July 27th 2022 and last updated two days later. 56 volunteers are needed at a single site for this trial to be conducted successfully."

Answered by AI

Has the FDA accorded its sanction to Nicotine as a therapeutic agent?

"Due to the limited evidence on Nicotine's efficacy and safety, it has been assigned a score of 1."

Answered by AI

What is the cap on total participants in this research?

"Affirmative. According to information on clinicaltrials.gov, this experiment is currently enrolling participants and was initially posted on July 27th 2022 with a recent update in the ensuing day. A total of 56 individuals are needed for this study at only one facility."

Answered by AI

Who else is applying?

What state do they live in?
California
Nevada
Maryland
What site did they apply to?
Johns Hopkins Behavioral Pharmacology Research Unit
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I want to learn everything about nicotine.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers
2022. "Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05335915.
~24 spots leftby Sep 2025
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