Nicotine DependenceEarly Phase 1NCT03580525
Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol
A Early Phase 1 study testing Nicotine saline infusion 0.00mcg/kg/s, Nicotine infusion 0.24mcg/kg/s and Nicotine infusion 0.096mcg/kg/s in people with Nicotine Dependence, run by Yale University at 1 site in United States.
Trial summary
A placebo-controlled study to enroll male and female tobacco smokers who will participate in five experimental sessions. subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec). Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Nicotine saline infusion 0.00mcg/kg/s, Nicotine infusion 0.24mcg/kg/s and Nicotine infusion 0.096mcg/kg/s
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2019to 19 Nov 2020
- Phase
- Early 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female and male smokers, aged 18 to 35 years, who have been smoking tobacco cigarettes for at least a year
- Smoke ≥ 5 and less than 20 cigarettes per day;
- Urine cotinine levels > 100 ng/mL consistent with nicotine intake of an active smoker (23)
- Not seeking treatment at the time of the study for nicotine dependence;
- In good health as verified by medical history, screening examination, and screening laboratory tests
- For women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
Who cannot join
- History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study
- Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
- Current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine
- Use of e-cigarettes more than 10 days in the past 30 days
- Urine drug screening indicating recent illicit drugs use (with the exception of marijuana).
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Hospital
West Haven, Connecticut, 06516
About this study
A placebo-controlled study to enroll male and female tobacco smokers who will participate in five experimental sessions. subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec).
Read the detailed description
A placebo-controlled study that will enroll male and female tobacco smokers' menthol to participate in five experimental sessions. During the experimental session, subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec). The infusion conditions for each experimental session will be determined in random order. Aim 1 is to establish a dose-effect curve for positive subjective effects (drug liking and good drug effects) and alleviation of smoking urges, as a function of nicotine delivery rate in menthol and non-menthol cigarette preferring smokers Aim 2 is to establish a dose-effect curve positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate. Aim 3 is to establish a dose-effect curve for nicotine's effect to alleviate symptoms of nicotine withdrawal in abstinent smokers as a function of nicotine delivery rate. Aim 4 is to establish a dose-effect curve for nicotine's acute cardiovascular health effects. Data from this project will help to establish benchmark values for nicotine's threshold effects that will guide policies on the nicotine yield of tobacco products. Presented is the time frame at which the peak change was strongest by treatment arm. The possible peak numbers could be 1, 3, 5, 7 and 10 minutes."
- Conditions
- Nicotine Dependence
- Being tested
- Nicotine saline infusion 0.00mcg/kg/s, Nicotine infusion 0.24mcg/kg/s, Nicotine infusion 0.096mcg/kg/s, Nicotine infusion 0.048 mcg/kg/s, Nicotine infusion 0.024mcg/kg/s
- 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.
Nicotine saline infusion 0.00mcg/kg/sDrug
Also called nicotine infusion
saline 0.00mcg/kg/s
Nicotine infusion 0.24mcg/kg/sDrug
Also called nicotine infusion
nicotine 0.24mcg/kg/s
Nicotine infusion 0.096mcg/kg/sDrug
Also called nicotine infusion
nicotine 0.096mcg/kg/s
Nicotine infusion 0.048 mcg/kg/sDrug
Also called nicotine infusion
nicotine 0.048mcg/kg/s
Nicotine infusion 0.024mcg/kg/sDrug
Also called nicotine infusion
nicotine 0.024mcg/kg/s
| Study group | Role | What they receive |
|---|---|---|
| nicotine saline infusion 0.00mcg/kg/s | Experimental | 0.00 mcg/kg/s The day order will be randomized per day Receives: Drug: Nicotine saline infusion 0.00mcg/kg/s |
| nicotine infusion 0.24mcg/kg/s | Experimental | 0.24mcg/kg/s The day order will be randomized per day Receives: Drug: Nicotine infusion 0.24mcg/kg/s |
| nicotine infusion 0.096mcg/kg/s | Experimental | 0.096mcg/kg/s The day order will be randomized per day Receives: Drug: Nicotine infusion 0.096mcg/kg/s |
| nicotine infusion 0.048mcg/kg/s | Experimental | 0.048mcg/kg/s The day order will be randomized per day Receives: Drug: Nicotine infusion 0.048 mcg/kg/s |
| nicotine infusion 0.024mcg/kg/s | Experimental | 0.048mcg/kg/s The day order will be randomized per day Receives: Drug: Nicotine infusion 0.024mcg/kg/s |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects
The peak change in the intensity of subjective effects as measured by the DEQ: Drug stimulatory effects questionnaire; Eleven questions with a minimum score of 0 to a maximum score of 100. Presented is the DEQ score at which the peak change was strongest by treatment arm. Each session took approximately 60 minutes, however the measures were only collected up to 10 minutes post infusion. This correction to the outcome time frame was made when the results were entered. Data were collected at 1, 3, 5, 7 and 10 minute intervals. The outcome measure title DEQ Stimulatory Effects measure was also updated.
Measured: up to 10 minutes
Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Pleasurable Effects
The peak change in the intensity of subjective effects as measured by the DEQ: Drug pleasurable effects questionnaire; Eleven questions with a minimum score of 0 to a maximum score of 100. Presented is the DEQ score at which the peak change was strongest by treatment arm. Each session took approximately 60 minutes, however the measures were only collected up to 10 minutes post infusion. This correction to the outcome time frame was made when the results were entered. Data were collected at 1, 3, 5, 7 and 10 minute intervals. The outcome measure title DEQ Stimulatory Effects measure was also updated.
Measured: up to 10 minutes post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start14 Feb 2019
- Primary completion19 Nov 2020
- Study completion19 Nov 2020
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 DependenceStudies 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single blind, placebo-controlled, mixed-design with nicotine delivery as a within-subjects factor.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mehmet Sofuoglu, Yale University
- Investigators
- Mehmet Sofuoglu, M.D.,Ph.D., Principal investigator, Professor of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580525
- Sponsor's protocol ID
- 2000023289
- Other IDs
- R03DA043004-01
- Status last verified
- Mar 2024
- First submitted
- 26 Jun 2018
- Last updated
- 12 Mar 2024
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol
- ClinicalTrials.gov ID
- NCT03580525
- Acronym / sponsor ID
- 2000023289
- Conditions
- Nicotine Dependence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 19 Nov 2020 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Posted 3 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A placebo-controlled study to enroll male and female tobacco smokers who will participate in five experimental sessions. subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec).
Detailed description
A placebo-controlled study that will enroll male and female tobacco smokers' menthol to participate in five experimental sessions. During the experimental session, subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec). The infusion conditions for each experimental session will be determined in random order. Aim 1 is to establish a dose-effect curve for positive subjective effects (drug liking and good drug effects) and alleviation of smoking urges, as a function of nicotine delivery rate in menthol and non-menthol cigarette preferring smokers Aim 2 is to establish a dose-effect curve positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate. Aim 3 is to establish a dose-effect curve for nicotine's effect to alleviate symptoms of nicotine withdrawal in abstinent smokers as a function of nicotine delivery rate. Aim 4 is to establish a dose-effect curve for nicotine's acute cardiovascular health effects. Data from this project will help to establish benchmark values for nicotine's threshold effects that will guide policies on the nicotine yield of tobacco products. Presented is the time frame at which the peak change was strongest by treatment arm. The possible peak numbers could be 1, 3, 5, 7 and 10 minutes."
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Single blind, placebo-controlled, mixed-design with nicotine delivery as a within-subjects factor.
| Arm | Type | Receives |
|---|---|---|
| nicotine saline infusion 0.00mcg/kg/s | Experimental | Drug: Nicotine saline infusion 0.00mcg/kg/s0.00 mcg/kg/s The day order will be randomized per day |
| nicotine infusion 0.24mcg/kg/s | Experimental | Drug: Nicotine infusion 0.24mcg/kg/s0.24mcg/kg/s The day order will be randomized per day |
| nicotine infusion 0.096mcg/kg/s | Experimental | Drug: Nicotine infusion 0.096mcg/kg/s0.096mcg/kg/s The day order will be randomized per day |
| nicotine infusion 0.048mcg/kg/s | Experimental | Drug: Nicotine infusion 0.048 mcg/kg/s0.048mcg/kg/s The day order will be randomized per day |
| nicotine infusion 0.024mcg/kg/s | Experimental | Drug: Nicotine infusion 0.024mcg/kg/s0.048mcg/kg/s The day order will be randomized per day |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female and male smokers, aged 18 to 35 years, who have been smoking tobacco cigarettes for at least a year
- Smoke ≥ 5 and less than 20 cigarettes per day;
- Urine cotinine levels > 100 ng/mL consistent with nicotine intake of an active smoker (23)
- Not seeking treatment at the time of the study for nicotine dependence;
- In good health as verified by medical history, screening examination, and screening laboratory tests
Key exclusion criteria (5 listed)
- History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study
- Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
- Current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine
- Use of e-cigarettes more than 10 days in the past 30 days
- Urine drug screening indicating recent illicit drugs use (with the exception of marijuana).
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 saline infusion 0.00mcg/kg/sAlso: nicotine infusionsaline 0.00mcg/kg/s | Drug | nicotine saline infusion 0.00mcg/kg/s |
| Nicotine infusion 0.24mcg/kg/sAlso: nicotine infusionnicotine 0.24mcg/kg/s | Drug | nicotine infusion 0.24mcg/kg/s |
| Nicotine infusion 0.096mcg/kg/sAlso: nicotine infusionnicotine 0.096mcg/kg/s | Drug | nicotine infusion 0.096mcg/kg/s |
| Nicotine infusion 0.048 mcg/kg/sAlso: nicotine infusionnicotine 0.048mcg/kg/s | Drug | nicotine infusion 0.048mcg/kg/s |
| Nicotine infusion 0.024mcg/kg/sAlso: nicotine infusionnicotine 0.024mcg/kg/s | Drug | nicotine infusion 0.024mcg/kg/s |
Primary outcome
Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects
Time frame: up to 10 minutes
The peak change in the intensity of subjective effects as measured by the DEQ: Drug stimulatory effects questionnaire; Eleven questions with a minimum score of 0 to a maximum score of 100. Presented is the DEQ score at which the peak change was strongest by treatment arm. Each session took approximately 60 minutes, however the measures were only collected up to 10 minutes post infusion. This correction to the outcome time frame was made when the results were entered. Data were collected at 1, 3, 5, 7 and 10 minute intervals. The outcome measure title DEQ Stimulatory Effects measure was also updated.
Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Pleasurable Effects
Time frame: up to 10 minutes post infusion
The peak change in the intensity of subjective effects as measured by the DEQ: Drug pleasurable effects questionnaire; Eleven questions with a minimum score of 0 to a maximum score of 100. Presented is the DEQ score at which the peak change was strongest by treatment arm. Each session took approximately 60 minutes, however the measures were only collected up to 10 minutes post infusion. This correction to the outcome time frame was made when the results were entered. Data were collected at 1, 3, 5, 7 and 10 minute intervals. The outcome measure title DEQ Stimulatory Effects measure was also updated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- 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.
Mehmet Sofuoglu, M.D.,Ph.D. principal investigator
Professor of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nicotine saline infusion 0.00mcg/kg/s, Nicotine infusion 0.24mcg/kg/s and Nicotine infusion 0.096mcg/kg/s in people with Nicotine Dependence, 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 6 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 12 Mar 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 3 Oct 2023). 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?
Peak Changes on Items of the Drug Effects Questionnaire (DEQ) - Stimulatory Effects (time frame: up to 10 minutes). 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 12 Mar 2024.