NicotineEarly Phase 1NCT03134339
The Effect of Nicotine Delivery Rate on Reinforcement
A Early Phase 1 study testing Nicotine saline 0.00mcg/kg/s, Nicotine 0.24 mcg/kg/s and Nicotine 0.048 mcg/kg/s in people with Nicotine, run by Yale University at 1 site in United States.
Trial summary
The dose-effect curve to estimate a threshold delivery rate for reinforcement. The project addresses the FDA Center for Tobacco Products (CTP) interest #1: Nicotine dependence threshold among youth and adults and impact of nicotine reduction on tobacco product use behavior (e.g., topography, compensation, switching… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Nicotine
- What is being tested?
- Nicotine saline 0.00mcg/kg/s, Nicotine 0.24 mcg/kg/s and Nicotine 0.048 mcg/kg/s
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2017to 29 Jan 2018
- Phase
- Early 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female and male smokers that smoke ≥ 5 cigarettes per day for the past year
- aged 18 to 30 years
- 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
- urine drug screening indicating recent illicit drugs use (with the exception of marijuana).
Trial locations and contacts
1 site in 1 country.
About this study
The dose-effect curve to estimate a threshold delivery rate for reinforcement. The project addresses the FDA Center for Tobacco Products (CTP) interest #1: Nicotine dependence threshold among youth and adults and impact of nicotine reduction on tobacco product use behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation and relapse). IV nicotine, in contrast to ECs, can deliver precise, reproducible dosing, which is necessary for accurately assessing dose-response and threshold effects. The estimated threshold for reinforcement will establish a benchmark for evaluating the addictive potential of ECs and other inhaled nicotine products.
Read the detailed description
A placebo-controlled study that will recruit male and female nicotine dependent smokers/EC users (n=18) to complete four separate experimental sessions. Each session will include one randomly assigned infusion that will be either saline or a single dose of nicotine (1 mg per 70 kg body weight) delivered at three different infusion rates, rapid, moderate or slow (0.24, 0.048 or 0.024 mcg per kg body weight per second). A total infusion duration of 10 min will be maintained during each session by adding saline infusions of variable duration after nicotine delivery. This will be achieved by two separate infusion pumps, one for saline and one for nicotine. For example, the rapid 0.24 mcg/kg/s condition will include a 1 min infusion of nicotine followed by a 9 min infusion of saline. The subjects will be blinded to the infusion pump procedures. The rapid delivery rate, which we have used in our prior studies, induces positive subjective drug effects and suppresses symptoms of nicotine withdrawal. The moderate delivery rate,0.048 mcg/kg/s, approximates the rate of nicotine intake encountered while smoking a typical cigarette over 5 min (4). The slowest nicotine delivery rate, 0.024mcg/kg/s, was chosen to approximate the rate of nicotine intake encountered while using a newer EC (5).
- Conditions
- Nicotine
- Being tested
- Nicotine saline 0.00mcg/kg/s, Nicotine 0.24 mcg/kg/s, Nicotine 0.048 mcg/kg/s, Nicotine 0.024 mcg/kg/s
- Keywords
- nicotine, smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine saline 0.00mcg/kg/sDrug
Also called nicotine infusion
saline 0.00mcg/kg/s
Nicotine 0.24 mcg/kg/sDrug
Also called nicotine infusion
nicotine 0.24 mcg/kg/s
Nicotine 0.048 mcg/kg/sDrug
Also called nicotine infusion
nicotine 0.048 mcg/kg/s
Nicotine 0.024 mcg/kg/sDrug
Also called nicotine infusion
nicotine 0.024 mcg/kg/s
| Study group | Role | What they receive |
|---|---|---|
| saline 0.00mcg/kg/s | Experimental | 0.00 mcg/kg/s The day order will be randomized per day Receives: Drug: Nicotine saline 0.00mcg/kg/s |
| 0.24mcg/kg/s | Experimental | 0.24 mcg/kg/s The day order will be randomized per day Receives: Drug: Nicotine 0.24 mcg/kg/s |
| 0.048mcg/kg/s | Experimental | 0.048 mcg/kg/s The day order will be randomized per day Receives: Drug: Nicotine 0.048 mcg/kg/s |
| 0.024 mcg/kg/s | Experimental | 0.024 mcg/kg/s The day order will be randomized per day Receives: Drug: Nicotine 0.024 mcg/kg/s |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Change on items of the Drug Effects Questionnaire (DEQ)
The peak change in the intensity of subjective effects as measured by the DEQ
Measured: up to 60 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 posted28 Apr 2017
- Study start5 Jan 2017
- Primary completion29 Jan 2018
- Study completion29 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NicotineStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The effects of different IV nicotine delivery rates of (saline), 0.24, 0.048 and 0.024 mcg/kg/s), as a within-subject factor, on peak change in the intensity of subjective effects as measured by the DEQ, will be used as a measured of a reinforcing threshold.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Sofuoglu, Yale University
- Investigators
- Kevin Jensen, Ph.D., Principal investigator, Yale UniversityMehmet Sofuoglu, M.D.,Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134339
- Sponsor's protocol ID
- 1609018390
- Status last verified
- Oct 2018
- First submitted
- 6 Feb 2017
- Last updated
- 22 Oct 2018
- Results posted
- No
- 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 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nicotine Delivery Rate on Reinforcement
- ClinicalTrials.gov ID
- NCT03134339
- Acronym / sponsor ID
- 1609018390
- Conditions
- Nicotine
- Keywords
- nicotine, smoking
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 28 Apr 2017 (actual)
- 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.
The dose-effect curve to estimate a threshold delivery rate for reinforcement. The project addresses the FDA Center for Tobacco Products (CTP) interest #1: Nicotine dependence threshold among youth and adults and impact of nicotine reduction on tobacco product use behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation and relapse). IV nicotine, in contrast to ECs, can deliver precise, reproducible dosing, which is necessary for accurately assessing dose-response and threshold effects. The estimated threshold for reinforcement will establish a benchmark for evaluating the addictive potential of ECs and other inhaled nicotine products.
Detailed description
A placebo-controlled study that will recruit male and female nicotine dependent smokers/EC users (n=18) to complete four separate experimental sessions. Each session will include one randomly assigned infusion that will be either saline or a single dose of nicotine (1 mg per 70 kg body weight) delivered at three different infusion rates, rapid, moderate or slow (0.24, 0.048 or 0.024 mcg per kg body weight per second). A total infusion duration of 10 min will be maintained during each session by adding saline infusions of variable duration after nicotine delivery. This will be achieved by two separate infusion pumps, one for saline and one for nicotine. For example, the rapid 0.24 mcg/kg/s condition will include a 1 min infusion of nicotine followed by a 9 min infusion of saline. The subjects will be blinded to the infusion pump procedures. The rapid delivery rate, which we have used in our prior studies, induces positive subjective drug effects and suppresses symptoms of nicotine withdrawal. The moderate delivery rate,0.048 mcg/kg/s, approximates the rate of nicotine intake encountered while smoking a typical cigarette over 5 min (4). The slowest nicotine delivery rate, 0.024mcg/kg/s, was chosen to approximate the rate of nicotine intake encountered while using a newer EC (5).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- The effects of different IV nicotine delivery rates of (saline), 0.24, 0.048 and 0.024 mcg/kg/s), as a within-subject factor, on peak change in the intensity of subjective effects as measured by the DEQ, will be used as a measured of a reinforcing threshold.
| Arm | Type | Receives |
|---|---|---|
| saline 0.00mcg/kg/s | Experimental | Drug: Nicotine saline 0.00mcg/kg/s0.00 mcg/kg/s The day order will be randomized per day |
| 0.24mcg/kg/s | Experimental | Drug: Nicotine 0.24 mcg/kg/s0.24 mcg/kg/s The day order will be randomized per day |
| 0.048mcg/kg/s | Experimental | Drug: Nicotine 0.048 mcg/kg/s0.048 mcg/kg/s The day order will be randomized per day |
| 0.024 mcg/kg/s | Experimental | Drug: Nicotine 0.024 mcg/kg/s0.024 mcg/kg/s The day order will be randomized per day |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female and male smokers that smoke ≥ 5 cigarettes per day for the past year
- aged 18 to 30 years
- 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 (4 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
- 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 0.00mcg/kg/sAlso: nicotine infusionsaline 0.00mcg/kg/s | Drug | saline 0.00mcg/kg/s |
| Nicotine 0.24 mcg/kg/sAlso: nicotine infusionnicotine 0.24 mcg/kg/s | Drug | 0.24mcg/kg/s |
| Nicotine 0.048 mcg/kg/sAlso: nicotine infusionnicotine 0.048 mcg/kg/s | Drug | 0.048mcg/kg/s |
| Nicotine 0.024 mcg/kg/sAlso: nicotine infusionnicotine 0.024 mcg/kg/s | Drug | 0.024 mcg/kg/s |
Primary outcome
Peak Change on items of the Drug Effects Questionnaire (DEQ)
Time frame: up to 60 minutes post infusion
The peak change in the intensity of subjective effects as measured by the DEQ
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 22 Oct 2018.
- 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.
Kevin Jensen, Ph.D. principal investigator
Yale University
Mehmet Sofuoglu, M.D.,Ph.D. principal investigator
Yale University
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 0.00mcg/kg/s, Nicotine 0.24 mcg/kg/s and Nicotine 0.048 mcg/kg/s in people with Nicotine, 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 4 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 Oct 2018. 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?
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?
Peak Change on items of the Drug Effects Questionnaire (DEQ) (time frame: up to 60 minutes post infusion). 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 Oct 2018.