Nicotine WithdrawalPhase 1NCT05335915
Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers
A Phase 1 study testing Nicotine and Cigarette in people with Nicotine Withdrawal and Nicotine Addiction, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of "tobacco-free" oral nicotine pouches, at various doses and flavors, in healthy adult smokers. The study will utilize a within-subjects, double-blind design. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Withdrawal, Nicotine Addiction, Drug Effect
- What is being tested?
- Nicotine and Cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2022to 29 Aug 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 21 years old
- good general health based on screening procedures (e.g., physical exam, blood testing)
- vital signs in normal range (resting heart rate less than 100bpm, systolic blood pressure less than 150mmHg, diastolic blood pressure less than 90mmHg)
- negative urine test for illicit drug use (excluding THC) and negative breath alcohol test at screening and before each session
- self-report currently smoking daily
- self-report at least a one year history of regular smoking
Show all 11Show fewer
- exhaled breath CO greater than or equal to 10ppm and urine cotinine greater than 100 ng/ml at screening
- meet criteria for at least mild tobacco use disorder
- no self-reported regular use of other tobacco products (e.g., smokeless products, e-cigarettes) in the past 30 days
- no self-reported prior use of novel oral nicotine pouches
- exhaled breath CO less than 10 ppm upon arrival for each study session.
Who cannot join
- Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
- Current use of over-the-counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigators or medical staff, will impact safety
- Use of cannabis >4 times per week
- History of or current significant medical condition that, in the opinion of the investigators or medical staff, will impact safety
- Current psychiatric condition or substance use disorder (aside from tobacco use disorder) that, in the opinion of the investigators or medical staff, will impact safety or study outcomes
- Women who are pregnant, planning to become pregnant, or are breast-feeding
- Currently seeking treatment to quit smoking or currently using a nicotine/tobacco cessation product.
- Enrollment in another clinical trial in the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of "tobacco-free" oral nicotine pouches, at various doses and flavors, in healthy adult smokers. The study will utilize a within-subjects, double-blind design. Upon enrollment, participants will complete 7 dosing conditions: tobacco-flavored pouch (low or high nicotine dose), mint/menthol-flavored pouch (low or high nicotine dose), and fruit-flavored pouch (low or high nicotine dose); participants will also complete a condition where the participants will smoke participants' preferred brand of cigarettes. In each experimental session, participants will complete 2 product-use bouts. In bout 1, the participants will use a single product (pouch or cigarette) for a fixed period under controlled conditions. In bout 2, participants will be given 2 hours to use participants' assigned product ad libitum.
Read the detailed description
The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of "tobacco-free" oral nicotine pouches, at various doses and flavors, in healthy adult smokers. The study will utilize a within-subjects, double-blind design. Upon enrollment, participants will complete 7 dosing conditions: tobacco-flavored pouch (low or high nicotine dose), mint/menthol-flavored pouch (low or high nicotine dose), and fruit-flavored pouch (low or high nicotine dose); participants will also complete a condition where the participants will smoke participants' preferred brand of cigarettes. In each experimental session, participants will complete 2 product-use bouts. In bout 1, the participants will use a single product (pouch or cigarette) for a fixed period under controlled conditions. In bout 2, participants will be given 2 hours to use participants' assigned product ad libitum. Blood specimens will be obtained throughout the sessions to characterize the pharmacokinetics of nicotine and various pharmacodynamic outcomes (subjective drug effects, tobacco withdrawal symptoms, vital signs) will also be assessed. These procedures will be completed 7 separate times (on separate visits) by each participant (sessions will be separated by at least 48 hours).
- Conditions
- Nicotine Withdrawal, Nicotine Addiction, Drug Effect
- Being tested
- Nicotine, Cigarette
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineOther
Also called Tobacco
Nicotine pouches will be self-administered
CigaretteOther
Also called Nicotine, Tobacco
Cigarette will be smoked
| Study group | Role | What they receive |
|---|---|---|
| Original/Tobacco Flavored Pouch (low nicotine dose) | Experimental | participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions Receives: Other: Nicotine |
| Original/Tobacco Flavored Pouch (high nicotine dose) | Experimental | participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions Receives: Other: Nicotine |
| Mint/Menthol Flavored Pouch (low nicotine dose) | Experimental | participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions Receives: Other: Nicotine |
| Mint/Menthol Flavored Pouch (high nicotine dose) | Experimental | participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions Receives: Other: Nicotine |
| Fruit Flavored Pouch (low nicotine dose) | Experimental | participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions Receives: Other: Nicotine |
| Fruit Flavored Pouch (high nicotine dose) | Experimental | participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions Receives: Other: Nicotine |
| Own brand cigarettes | Active comparator | participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions Receives: Other: Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Nicotine as Assessed by the Cmax (20-min Directed Bout)
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Maximum concentration (Cmax), is the highest plasma nicotine concentration reached during a session and provides important insight into the abuse liability of a tobacco product. Bout 1 (20min directed use) Cmax was calculated based on post-baseline blood timepoints which include 10 minutes, 20 minutes, 30 minutes, and 1 hour after bout 1 dosing.
Measured: 0 to 1 hour
Pharmacokinetics of Nicotine as Assessed by the AUC (20 Min Directed Bout)
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Area under the curve (AUC), represents the total nicotine exposure during an entire nicotine use period and provides important insight into the abuse liability of a tobacco product. Data is reported as the mean (SD) change from baseline. Bout 1 (20min directed use) AUC was calculated based on post-baseline blood timepoints which include 10 minutes, 20 minutes, 30 minutes, and 1 hour after bout 1 dosing.
Measured: 0 to 1 hour
Peak Change From Baseline Subjective Ratings of "Like Drug Effect" as Assessed by the Drug Effect Questionnaire
The DEQ will be used to obtain subjective ratings of "like drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater liking. Data is reported as mean (SD) change from baseline. A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Measured: Up to 6.5 hours
Subjective Ratings of "Pleasant Drug Effect" as Assessed by the Drug Effect Questionnaire
The DEQ will be used to obtain subjective ratings of "pleasant drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater "pleasant drug effect". A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Measured: Up to 6.5 hours
Subjective Ratings of "Take Again" as Assessed by the Drug Effect Questionnaire
The DEQ will be used to obtain subjective ratings of "take again". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation, with higher score indicating greater "take again" rating. A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Measured: Up to 6.5 hours
Subjective Ratings of "Urge to Smoke" as Assessed by the Hughes-Hatsukami Withdrawal Questionnaire (Change From Baseline)
The HHWS will be used to obtain subjective ratings of "urge to smoke". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater "urge to smoke". A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Measured: Up to 6.5 hours
Subjective Ratings of "Craving to Smoke" as Assessed by the Hughes-Hatsukami Withdrawal Questionnaire (Change From Baseline)
The HHWS will be used to obtain subjective ratings of "craving to smoke". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation, with higher score indicating greater "craving to smoke". A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Measured: Up to 6.5 hours
Secondary outcomes (7)
Pharmacokinetics of Nicotine as Assessed by the Tmax
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Time to maximum concentration (Tmax), is the time (in minutes) to reach Cmax. This is another measure relevant for abuse liability. Tmax for bout 1 was calculated based on post-baseline blood timepoints which include 20 minutes, 30 minutes, and 1 hour after bout 1 dosing.
Measured: Up to1 hour
Tobacco Withdrawal Symptoms as Assessed by the Tiffany-Drobes QSU Brief-Factor 1 (Change From Baseline)
The QSU-brief factor 1 (intention to smoke) measures tobacco withdrawal symptoms using 5 items; scores are summed to produce a single score ranging from 0 to 30. Higher scores indicates greater withdrawal symptoms. A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Measured: Up to 6.5 hours
Tobacco Withdrawal Symptoms as Assessed by the Tiffany-Drobes QSU Brief-Factor 2 (Change From Baseline)
The QSU-brief factor 2 (anticipation of relief) measures tobacco withdrawal symptoms using 5 items; scores are summed to produce a single score ranging from 0 to 24. Higher scores indicates greater/worse withdrawal symptoms.
Measured: 6.5 hours
Topography as Assessed by the Total Time of Use
During the 2 hour ad libitum bout, topography will be collected. The total time of use (out of 2 hours) will be assessed.
Measured: 2 hours
The Direct Effects of Nicotine Scale (DENS) (Change From Baseline)
The DENS will assess nicotine-specific effects. Scores on all items range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. Higher scores indicates stronger (better) nicotine related effects.
Measured: 6.5 hours
Perceived Strength of Effects as Assessed by the Drug Effect Questionnaire
The DEQ will assess subjective ratings for "feel drug effect". Scores range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater "feel drug effect". Higher scores indicates stronger (better) effects. A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Measured: Up to 6.5 hours
Negative and Aversive Effects as Assessed by the Drug Effect Questionnaire
The DEQ will assess subjective ratings for "dislike drug effect". Scores range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating a stronger (worse) perception of aversive or unpleasant drug effects. A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Measured: Up to 6.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start27 Jul 2022
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine WithdrawalStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will complete all dose conditions (study arms) in a randomized order
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Tory Spindle, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335915
- Sponsor's protocol ID
- IRB00318560
- Other IDs
- 1R01DA055962-01
- Status last verified
- Jun 2026
- First submitted
- 12 Apr 2022
- Last updated
- 23 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers
- ClinicalTrials.gov ID
- NCT05335915
- Acronym / sponsor ID
- IRB00318560
- Conditions
- Nicotine Withdrawal, Nicotine Addiction, Drug Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Posted 23 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of "tobacco-free" oral nicotine pouches, at various doses and flavors, in healthy adult smokers. The study will utilize a within-subjects, double-blind design. Upon enrollment, participants will complete 7 dosing conditions: tobacco-flavored pouch (low or high nicotine dose), mint/menthol-flavored pouch (low or high nicotine dose), and fruit-flavored pouch (low or high nicotine dose); participants will also complete a condition where the participants will smoke participants' preferred brand of cigarettes. In each experimental session, participants will complete 2 product-use bouts. In bout 1, the participants will use a single product (pouch or cigarette) for a fixed period under controlled conditions. In bout 2, participants will be given 2 hours to use participants' assigned product ad libitum.
Detailed description
The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of "tobacco-free" oral nicotine pouches, at various doses and flavors, in healthy adult smokers. The study will utilize a within-subjects, double-blind design. Upon enrollment, participants will complete 7 dosing conditions: tobacco-flavored pouch (low or high nicotine dose), mint/menthol-flavored pouch (low or high nicotine dose), and fruit-flavored pouch (low or high nicotine dose); participants will also complete a condition where the participants will smoke participants' preferred brand of cigarettes. In each experimental session, participants will complete 2 product-use bouts. In bout 1, the participants will use a single product (pouch or cigarette) for a fixed period under controlled conditions. In bout 2, participants will be given 2 hours to use participants' assigned product ad libitum. Blood specimens will be obtained throughout the sessions to characterize the pharmacokinetics of nicotine and various pharmacodynamic outcomes (subjective drug effects, tobacco withdrawal symptoms, vital signs) will also be assessed. These procedures will be completed 7 separate times (on separate visits) by each participant (sessions will be separated by at least 48 hours).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 7
- Model description
- All participants will complete all dose conditions (study arms) in a randomized order
| Arm | Type | Receives |
|---|---|---|
| Original/Tobacco Flavored Pouch (low nicotine dose) | Experimental | Other: Nicotineparticipants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions |
| Original/Tobacco Flavored Pouch (high nicotine dose) | Experimental | Other: Nicotineparticipants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions |
| Mint/Menthol Flavored Pouch (low nicotine dose) | Experimental | Other: Nicotineparticipants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions |
| Mint/Menthol Flavored Pouch (high nicotine dose) | Experimental | Other: Nicotineparticipants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions |
| Fruit Flavored Pouch (low nicotine dose) | Experimental | Other: Nicotineparticipants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions |
| Fruit Flavored Pouch (high nicotine dose) | Experimental | Other: Nicotineparticipants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions |
| Own brand cigarettes | Active comparator | Other: Cigaretteparticipants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 21 years old
- good general health based on screening procedures (e.g., physical exam, blood testing)
- vital signs in normal range (resting heart rate less than 100bpm, systolic blood pressure less than 150mmHg, diastolic blood pressure less than 90mmHg)
- negative urine test for illicit drug use (excluding THC) and negative breath alcohol test at screening and before each session
- self-report currently smoking daily
Key exclusion criteria (8 listed)
- Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
- Current use of over-the-counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigators or medical staff, will impact safety
- Use of cannabis >4 times per week
- History of or current significant medical condition that, in the opinion of the investigators or medical staff, will impact safety
- Current psychiatric condition or substance use disorder (aside from tobacco use disorder) that, in the opinion of the investigators or medical staff, will impact safety or study outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicotineAlso: TobaccoNicotine pouches will be self-administered | Other | Fruit Flavored Pouch (high nicotine dose), Fruit Flavored Pouch (low nicotine dose), Mint/Menthol Flavored Pouch (high nicotine dose), Mint/Menthol Flavored Pouch (low nicotine dose), Original/Tobacco Flavored Pouch (high nicotine dose), Original/Tobacco Flavored Pouch (low nicotine dose) |
| CigaretteAlso: Nicotine, TobaccoCigarette will be smoked | Other | Own brand cigarettes |
Primary outcome
Pharmacokinetics of Nicotine as Assessed by the Cmax (20-min Directed Bout)
Time frame: 0 to 1 hour
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Maximum concentration (Cmax), is the highest plasma nicotine concentration reached during a session and provides important insight into the abuse liability of a tobacco product. Bout 1 (20min directed use) Cmax was calculated based on post-baseline blood timepoints which include 10 minutes, 20 minutes, 30 minutes, and 1 hour after bout 1 dosing.
Pharmacokinetics of Nicotine as Assessed by the AUC (20 Min Directed Bout)
Time frame: 0 to 1 hour
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Area under the curve (AUC), represents the total nicotine exposure during an entire nicotine use period and provides important insight into the abuse liability of a tobacco product. Data is reported as the mean (SD) change from baseline. Bout 1 (20min directed use) AUC was calculated based on post-baseline blood timepoints which include 10 minutes, 20 minutes, 30 minutes, and 1 hour after bout 1 dosing.
Peak Change From Baseline Subjective Ratings of "Like Drug Effect" as Assessed by the Drug Effect Questionnaire
Time frame: Up to 6.5 hours
The DEQ will be used to obtain subjective ratings of "like drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater liking. Data is reported as mean (SD) change from baseline. A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Subjective Ratings of "Pleasant Drug Effect" as Assessed by the Drug Effect Questionnaire
Time frame: Up to 6.5 hours
The DEQ will be used to obtain subjective ratings of "pleasant drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater "pleasant drug effect". A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Subjective Ratings of "Take Again" as Assessed by the Drug Effect Questionnaire
Time frame: Up to 6.5 hours
The DEQ will be used to obtain subjective ratings of "take again". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation, with higher score indicating greater "take again" rating. A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Subjective Ratings of "Urge to Smoke" as Assessed by the Hughes-Hatsukami Withdrawal Questionnaire (Change From Baseline)
Time frame: Up to 6.5 hours
The HHWS will be used to obtain subjective ratings of "urge to smoke". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation with higher score indicating greater "urge to smoke". A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
Subjective Ratings of "Craving to Smoke" as Assessed by the Hughes-Hatsukami Withdrawal Questionnaire (Change From Baseline)
Time frame: Up to 6.5 hours
The HHWS will be used to obtain subjective ratings of "craving to smoke". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation, with higher score indicating greater "craving to smoke". A peak change from baseline score was calculated based on post-baseline timepoints which include 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 3.5 hours, 4.5 hours, and 6.5 hours after bout 1 dosing.
7 secondary outcomes
Pharmacokinetics of Nicotine as Assessed by the Tmax
Time frame: Up to1 hour
Tobacco Withdrawal Symptoms as Assessed by the Tiffany-Drobes QSU Brief-Factor 1 (Change From Baseline)
Time frame: Up to 6.5 hours
Tobacco Withdrawal Symptoms as Assessed by the Tiffany-Drobes QSU Brief-Factor 2 (Change From Baseline)
Time frame: 6.5 hours
Topography as Assessed by the Total Time of Use
Time frame: 2 hours
The Direct Effects of Nicotine Scale (DENS) (Change From Baseline)
Time frame: 6.5 hours
Perceived Strength of Effects as Assessed by the Drug Effect Questionnaire
Time frame: Up to 6.5 hours
Negative and Aversive Effects as Assessed by the Drug Effect Questionnaire
Time frame: Up to 6.5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tory Spindle, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nicotine and Cigarette in people with Nicotine Withdrawal and Nicotine Addiction, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of Nicotine as Assessed by the Cmax (20-min Directed Bout) (time frame: 0 to 1 hour). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.