Smoking CessationPhase 1/2NCT03674970
Effects of Random Nicotine Delivery on Smoking Cessation
A Phase 1/2 study testing Nicotine Film in people with Smoking Cessation and Cigarette Smoking, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The objective of this study is to determine whether treatment with random nicotine delivery via a nicotine film both before and after the target quit date will facilitate smoking cessation relative to treatment with steady state delivery or placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Cigarette Smoking, Smoking (Tobacco) Addiction
- What is being tested?
- Nicotine Film
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2019to 25 Nov 2019
- Phase
- Phase 1/2
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-55
- Smoke ≥10 cigarettes/day for at least the past 12 months
- Exhaled CO measurement ≥6 ppm at baseline visit
- Interested in completely ceasing cigarette consumption and using a nicotine film product as directed
- Willing to attend regular visits over a 6-week period (not planning to move, not planning extended vacation, no planned surgeries)
- Able to read and write in English
- Able to understand and consent to study procedures
Who cannot join
- Unstable or significant medical conditions and conditions such as elevated blood pressure (systolic >159 mmHg or diastolic >99mmHg at baseline), COPD, and those conditions that are likely to affect biomarker data such as kidney or liver disease
- Individuals with sodium-restricted diet, heart disease, recent heart attack, irregular heartbeat, stomach ulcers, or diabetes as well as those taking prescription medications for depression or asthma as indicated under "Warnings" section on FDA approved NRT Drug Facts Label
- More than weekly use in the past 3 months of illegal drugs or prescription drugs that are not being used for medically prescribed purposes
- Use of non-cigarette nicotine delivery product in the prior 7 days (including cigars, pipes, chew, snus, hookah, electronic cigarette and marijuana mixed with tobacco)
- Use of an FDA approved cessation medication in the past 7 days (any NRT, Chantix, Wellbutrin)
- Women who are pregnant (verified by urine pregnancy test at baseline visit), trying to become pregnant, or nursing
Show all 10Show fewer
- Uncontrolled mental illness or substance abuse or inpatient treatment for these conditions in the past 6 months
- Any previous adverse reaction to NRT
- Any other condition, serious illness, or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol
- Other member of household currently participating in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
The objective of this study is to determine whether treatment with random nicotine delivery via a nicotine film both before and after the target quit date will facilitate smoking cessation relative to treatment with steady state delivery or placebo.
The investigators hypothesize that smoking cessation will be greater in subjects assigned to a random nicotine delivery regimen (as compared to those assigned to a steady state or placebo regimen). The nicotine film product is not part of the standard of care and is not available in non-investigational settings in the United States.
Read the detailed description
This project is a prospective parallel-group, randomized, double-blind, placebo-controlled study in which 45 current cigarette smokers who are interested in quitting will be randomly allocated to one of three possible nicotine film treatment regimens:
- Random nicotine delivery (a combination of four 0 mg and 4 mg films daily not to exceed three non-consecutive 4 mg films in one day and to maintain an average of 8 mg of nicotine per day through 7 days for 6 weeks total).
- Steady state nicotine delivery (2, 2, 2, 2 mg films daily for 6 weeks total)
- Placebo delivery (0, 0, 0, 0 mg films daily for 6 weeks total)
Prior to assignment in one of the above treatment groups, all participants will take part in a 1-week baseline period to assess normal smoking behavior and nicotine dependence. Following randomization to their assigned treatment group at Visit 2, participants will be instructed to smoke cigarettes as they feel necessary over the next two weeks while using the nicotine films as directed (i.e., one film every 3-4 hours for a total of four films per day). After two weeks of pre-cessation treatment, participants will be asked completely cease cigarette smoking and to only use their assigned nicotine films as directed. Participants will be supported in their quitting efforts with regular contacts both in person at the Penn State Milton S. Hershey Medical Center and over the phone.
- Being tested
- Nicotine Film
- Keywords
- smoking cessation, nicotine film, nicotine delivery, random nicotine delivery
- Medical subject headings
- Smoking Cessation, Cigarette Smoking, Smoking, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine FilmDrug
Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
| Study group | Role | What they receive |
|---|---|---|
| Random Nicotine Delivery | Experimental | One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks. Receives: Drug: Nicotine Film |
| Steady State Nicotine Delivery | Active comparator | One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks. Receives: Drug: Nicotine Film |
| Placebo Control | Placebo comparator | One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks. Receives: Drug: Nicotine Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Cigarettes Smoked Per Day (CPD)
CPD is measured with the use of daily cigarette logs which are completed daily by participants and returned to the study center at each visit. The CPD measure will be the average of the past 7 days.
Measured: Baseline and 4 weeks after Target Quit Date
Change in Exhaled Carbon Monoxide (CO) Measurement
Mean change in exhaled CO (parts per million [ppm])
Measured: Baseline and 4 weeks after Target Quit Date
Secondary outcomes (4)
Change in Questionnaire of Smoking Urges-Brief (QSU-Brief) Total Score
The QSU-Brief, with a possible total score range of 10 to 70, is an instrument used to measure cigarette craving. A score of 10 on this scale indicates very low cigarette craving, while a score of 70 indicates very high cigarette craving.
Measured: Baseline and 4 weeks after Target Quit Date
Change in Fagerstrom Test for Nicotine Dependence (FTND) Total Score
Nicotine dependence will be assessed via the FTND, a measure with total scores ranging from 0 (very low dependence) to 10 (very high dependence).
Measured: Baseline and 4 weeks after Target Quit Date
Subjective Ratings Scale for Nicotine Film Use
The scale is comprised of 21 items. Each item is rated on a scale 1-7, where 1 is equal to not at all and 7 is equal to extremely. The total score is the average score of all 21 items. The total score ranges from 1-7.
Measured: 4 weeks after Target Quit Date
Side Effects From Nicotine Film Use
Total score ranges from 0 - 36 with lower scores indicating lesser side effects.
Measured: 4 weeks after Target Quit Date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start12 Mar 2019
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
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 Smoking CessationStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Patricia Sue Grigson, Milton S. Hershey Medical Center
- Investigators
- Patricia S Grigson, PhD, Principal investigator, Penn State College of MedicineJonathan Foulds, PhD, Principal investigator, Penn State College of MedicineChristopher Sciamanna, MD, Study director, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674970
- Sponsor's protocol ID
- 9977
- Other IDs
- R21DA038775
- Status last verified
- Jan 2021
- First submitted
- 14 Sep 2018
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Random Nicotine Delivery on Smoking Cessation
- ClinicalTrials.gov ID
- NCT03674970
- Acronym / sponsor ID
- 9977
- Keywords
- smoking cessation, nicotine film, nicotine delivery, random nicotine delivery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Posted 22 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine whether treatment with random nicotine delivery via a nicotine film both before and after the target quit date will facilitate smoking cessation relative to treatment with steady state delivery or placebo.
The investigators hypothesize that smoking cessation will be greater in subjects assigned to a random nicotine delivery regimen (as compared to those assigned to a steady state or placebo regimen). The nicotine film product is not part of the standard of care and is not available in non-investigational settings in the United States.
Detailed description
This project is a prospective parallel-group, randomized, double-blind, placebo-controlled study in which 45 current cigarette smokers who are interested in quitting will be randomly allocated to one of three possible nicotine film treatment regimens:
- Random nicotine delivery (a combination of four 0 mg and 4 mg films daily not to exceed three non-consecutive 4 mg films in one day and to maintain an average of 8 mg of nicotine per day through 7 days for 6 weeks total).
- Steady state nicotine delivery (2, 2, 2, 2 mg films daily for 6 weeks total)
- Placebo delivery (0, 0, 0, 0 mg films daily for 6 weeks total)
Prior to assignment in one of the above treatment groups, all participants will take part in a 1-week baseline period to assess normal smoking behavior and nicotine dependence. Following randomization to their assigned treatment group at Visit 2, participants will be instructed to smoke cigarettes as they feel necessary over the next two weeks while using the nicotine films as directed (i.e., one film every 3-4 hours for a total of four films per day). After two weeks of pre-cessation treatment, participants will be asked completely cease cigarette smoking and to only use their assigned nicotine films as directed. Participants will be supported in their quitting efforts with regular contacts both in person at the Penn State Milton S. Hershey Medical Center and over the phone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Random Nicotine Delivery | Experimental | Drug: Nicotine FilmOne 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks. |
| Steady State Nicotine Delivery | Active comparator | Drug: Nicotine FilmOne 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks. |
| Placebo Control | Placebo comparator | Drug: Nicotine FilmOne 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 18-55
- Smoke ≥10 cigarettes/day for at least the past 12 months
- Exhaled CO measurement ≥6 ppm at baseline visit
- Interested in completely ceasing cigarette consumption and using a nicotine film product as directed
- Willing to attend regular visits over a 6-week period (not planning to move, not planning extended vacation, no planned surgeries)
Key exclusion criteria (10 listed)
- Unstable or significant medical conditions and conditions such as elevated blood pressure (systolic >159 mmHg or diastolic >99mmHg at baseline), COPD, and those conditions that are likely to affect biomarker data such as kidney or liver disease
- Individuals with sodium-restricted diet, heart disease, recent heart attack, irregular heartbeat, stomach ulcers, or diabetes as well as those taking prescription medications for depression or asthma as indicated under "Warnings" section on FDA approved NRT Drug Facts Label
- More than weekly use in the past 3 months of illegal drugs or prescription drugs that are not being used for medically prescribed purposes
- Use of non-cigarette nicotine delivery product in the prior 7 days (including cigars, pipes, chew, snus, hookah, electronic cigarette and marijuana mixed with tobacco)
- Use of an FDA approved cessation medication in the past 7 days (any NRT, Chantix, Wellbutrin)
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 |
|---|---|---|
| Nicotine FilmThree doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting. | Drug | Placebo Control, Random Nicotine Delivery, Steady State Nicotine Delivery |
Primary outcome
Change in Number of Cigarettes Smoked Per Day (CPD)
Time frame: Baseline and 4 weeks after Target Quit Date
CPD is measured with the use of daily cigarette logs which are completed daily by participants and returned to the study center at each visit. The CPD measure will be the average of the past 7 days.
Change in Exhaled Carbon Monoxide (CO) Measurement
Time frame: Baseline and 4 weeks after Target Quit Date
Mean change in exhaled CO (parts per million [ppm])
4 secondary outcomes
Change in Questionnaire of Smoking Urges-Brief (QSU-Brief) Total Score
Time frame: Baseline and 4 weeks after Target Quit Date
Change in Fagerstrom Test for Nicotine Dependence (FTND) Total Score
Time frame: Baseline and 4 weeks after Target Quit Date
Subjective Ratings Scale for Nicotine Film Use
Time frame: 4 weeks after Target Quit Date
Side Effects From Nicotine Film Use
Time frame: 4 weeks after Target Quit Date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- 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.
Patricia S Grigson, PhD principal investigator
Penn State College of Medicine
Jonathan Foulds, PhD principal investigator
Penn State College of Medicine
Christopher Sciamanna, MD study director
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nicotine Film in people with Smoking Cessation and Cigarette Smoking, run by Milton S. Hershey Medical Center 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 7 inclusion and 10 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 22 Jan 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 22 Jan 2021). 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?
Change in Number of Cigarettes Smoked Per Day (CPD) (time frame: Baseline and 4 weeks after Target Quit Date). The study lists 2 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 22 Jan 2021.