Nicotine Dependence, Other Tobacco ProductPhase 1NCT02179034
Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
A Phase 1 study testing Nicotine, Low Dose Menthol and High Dose Menthol in people with Nicotine Dependence, Other Tobacco Product, run by Yale University at 1 site in United States.
Trial summary
This study is to examine if inhaled doses of menthol that produce low and high cooling effects change the appeal of e-cigarettes containing low and high doses of nicotine in adolescent smokers. Read more about this study
- Who is it for?
- Ages 18 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Other Tobacco Product
- What is being tested?
- Nicotine, Low Dose Menthol and High Dose Menthol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2014to 12 Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-20 years
- Able to read and write
- Cigarette smoker
- Use of e-cigarettes in the past 30 days
Who cannot join
- Seeking smoking cessation treatment
- Current/lifetime criteria for dependence on another psychoactive substance -Daily use of alcohol or marijuana or use of any other drugs including cocaine, opiates, stimulants
- Regular use of psychoactive drugs including anxiolytics, antidepressants and other psychostimulants
- Current or past history of psychosis or other psychiatric diagnosis such as major depression
- Any significant current medical condition
Trial locations and contacts
1 site in 1 country.
About this study
This study is to examine if inhaled doses of menthol that produce low and high cooling effects change the appeal of e-cigarettes containing low and high doses of nicotine in adolescent smokers. The hypothesis is that the combination of nicotine and menthol, when compared with menthol or nicotine alone, will result in greater increase in liking of an e-cigarette and greater reduction in nicotine withdrawal.
- Being tested
- Nicotine, Low Dose Menthol, High Dose Menthol
- Keywords
- tobacco, electronic cigarettes, menthol, flavors
- Medical subject headings
- Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)
Low Dose MentholOther
A low dose of menthol will be added to the tobacco flavor.
High Dose MentholOther
A high dose of menthol will be added to the tobacco flavor.
| Study group | Role | What they receive |
|---|---|---|
| Tobacco Flavor | Placebo comparator | In this arm, subjects will receive tobacco flavor- without nicotine (placebo). Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose. Receives: Other: Low Dose Menthol; Other: High Dose Menthol |
| Low Dose Nicotine | Active comparator | In this arm, subjects will receive a low dose of nicotine (6 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose. Receives: Drug: Nicotine; Other: Low Dose Menthol; Other: High Dose Menthol |
| High Dose Nicotine | Active comparator | In this arm, subjects will receive a high dose of nicotine (12 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose. Receives: Drug: Nicotine; Other: Low Dose Menthol; Other: High Dose Menthol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liking/effect score of the e-cigarette
The Drug Effects Questionnaire (Soria et al) will be used to ask about participants' liking/effect of the e-cigarettes smoked during the 4 bouts of e-cigarette puffing during the lab session to determine which menthol dose is most preferred. A linear mixed-effects regression model wil be used with nicotine group (none, low, high) as between-subject factor, and menthol dose (none, low dose, high dose) as within-subject factor.
Measured: Every 30 min for 120 min during lab session
Secondary outcomes (3)
Maximum value of money at which the e-cigarette is chosen over money
E-cigarette value will be determined using the Multiple Choice Procedure (Griffiths et al, 1993) to determine the reinforcing value of the e-cigarette. The MCP involves sampling the e-cigarette and then making a discrete choice between the e-cigarette or a series of monetary values.
Measured: Every 30 min for 120 min during lab session
Change scores from baseline in Nicotine Withdrawal
The Minnesota Nicotine Withdrawal Scale (Hughes et al,1986) will be used to assess the magnitude of change in nicotine withdrawal symptoms during the lab session
Measured: Every 30 min for 120 min during lab session
Change scores from baseline in Tobacco Craving
The Brief Questionnaire on Smoking Urges (Tiffany \& Drobes,1991) will be used to assess the magnitude of change in tobacco craving during the lab session
Measured: Every 30 min for 120 min during lab session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study start23 Oct 2014
- Primary completion18 Jul 2016
- Study completion12 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine Dependence, Other Tobacco ProductStudies of the same condition, open and under way.
- More trials run by Yale 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana Cavallo, PhD, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179034
- Sponsor's protocol ID
- 1307012312
- Status last verified
- Apr 2020
- First submitted
- 24 Jun 2014
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
- ClinicalTrials.gov ID
- NCT02179034
- Acronym / sponsor ID
- 1307012312
- Keywords
- tobacco, electronic cigarettes, menthol, flavors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 23 Oct 2014 (actual)
- Primary completion
- 18 Jul 2016 (actual)
- Study completion
- 12 Jun 2017 (actual)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to examine if inhaled doses of menthol that produce low and high cooling effects change the appeal of e-cigarettes containing low and high doses of nicotine in adolescent smokers. The hypothesis is that the combination of nicotine and menthol, when compared with menthol or nicotine alone, will result in greater increase in liking of an e-cigarette and greater reduction in nicotine withdrawal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tobacco Flavor | Placebo comparator | Other: Low Dose Menthol, Other: High Dose MentholIn this arm, subjects will receive tobacco flavor- without nicotine (placebo). Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose. |
| Low Dose Nicotine | Active comparator | Drug: Nicotine, Other: Low Dose Menthol, Other: High Dose MentholIn this arm, subjects will receive a low dose of nicotine (6 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose. |
| High Dose Nicotine | Active comparator | Drug: Nicotine, Other: Low Dose Menthol, Other: High Dose MentholIn this arm, subjects will receive a high dose of nicotine (12 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose. |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages 18-20 years
- Able to read and write
- Cigarette smoker
- Use of e-cigarettes in the past 30 days
Key exclusion criteria (5 listed)
- Seeking smoking cessation treatment
- Current/lifetime criteria for dependence on another psychoactive substance -Daily use of alcohol or marijuana or use of any other drugs including cocaine, opiates, stimulants
- Regular use of psychoactive drugs including anxiolytics, antidepressants and other psychostimulants
- Current or past history of psychosis or other psychiatric diagnosis such as major depression
- Any significant current medical condition
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 |
|---|---|---|
| NicotineParticipants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml) | Drug | High Dose Nicotine, Low Dose Nicotine |
| Low Dose MentholA low dose of menthol will be added to the tobacco flavor. | Other | High Dose Nicotine, Low Dose Nicotine, Tobacco Flavor |
| High Dose MentholA high dose of menthol will be added to the tobacco flavor. | Other | High Dose Nicotine, Low Dose Nicotine, Tobacco Flavor |
Primary outcome
Liking/effect score of the e-cigarette
Time frame: Every 30 min for 120 min during lab session
The Drug Effects Questionnaire (Soria et al) will be used to ask about participants' liking/effect of the e-cigarettes smoked during the 4 bouts of e-cigarette puffing during the lab session to determine which menthol dose is most preferred. A linear mixed-effects regression model wil be used with nicotine group (none, low, high) as between-subject factor, and menthol dose (none, low dose, high dose) as within-subject factor.
3 secondary outcomes
Maximum value of money at which the e-cigarette is chosen over money
Time frame: Every 30 min for 120 min during lab session
Change scores from baseline in Nicotine Withdrawal
Time frame: Every 30 min for 120 min during lab session
Change scores from baseline in Tobacco Craving
Time frame: Every 30 min for 120 min during lab session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
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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.
Dana Cavallo, PhD study director
Yale 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, Low Dose Menthol and High Dose Menthol in people with Nicotine Dependence, Other Tobacco Product, run by Yale 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 4 inclusion and 5 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 4 May 2020. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Liking/effect score of the e-cigarette (time frame: Every 30 min for 120 min during lab session). 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 4 May 2020.