Smoking CessationEarly Phase 1NCT04488744
Smoking by IV Pulsed Nicotine
A Early Phase 1 study testing Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s in people with Smoking Cessation, run by Yale University at 1 site in United States.
Trial summary
To establish a dose-effect curve for nicotine's abuse potential as a function of nicotine dose and delivery rate. Pulsed IV nicotine administration will be used as it closely matches nicotine delivery by inhaled tobacco use. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2019to 31 May 2021
- 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 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
- 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; and 6) 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
Official title: Modeling Tobacco Smoking by IV Pulsed Nicotine in Smokers
To establish a dose-effect curve for nicotine's abuse potential as a function of nicotine dose and delivery rate. Pulsed IV nicotine administration will be used as it closely matches nicotine delivery by inhaled tobacco use.
Read the detailed description
Both sub-studies will enroll male and female tobacco cigarette smokers. This study will examine the feasibility of the proposed study parameters in a total of 10 completers. In a crossover design, participants will be tested under 5 conditions: 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries). The main outcome measures will be self-report drug effects and urges to smoke cigarettes.
The investigators hypothesize that the abuse potential and alleviation of smoking urges are produced by nicotine as a function of nicotine dose and delivery rate.
This study is complete with 13 enrolled and 10 completers
- Conditions
- Smoking Cessation
- Being tested
- Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine 0.2mcg/kg/s and 1.0mcg/kg/sDrug
Also called nicotine infusion
Nicotine infusion 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries).
| Study group | Role | What they receive |
|---|---|---|
| nicotine infusion 0.2mg | Experimental | nicotine infusion
0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) The day order will be randomized over 5 days. Receives: Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s |
| nicotine infusion 2.0mg | Experimental | 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), Receives: Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s |
| nicotine infusion 1.0mg | Experimental | 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) Receives: Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s |
| nicotine infuison 1.0mg | Experimental | 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries). Receives: Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s |
| Saline | Placebo comparator | saline delivered over 2minutes ,2.5minutes,10 minutes Receives: Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate will be used to see the dose effect
the dose-effect curves of nicotine dose and delivery rate in heart rate
Measured: During nicotine infusion max of ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start15 Nov 2019
- Primary completion28 Apr 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- placebo-controlled, mixed-design with nicotine dose as a between-subject and nicotine delivery rate as a within-subject factor.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Sofuoglu, Yale University
- Investigators
- Mehmet Sofuoglu, M.D.,Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488744
- Sponsor's protocol ID
- MS059
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2020
- Last updated
- 20 Jul 2021
- 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 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling Tobacco Smoking by IV Pulsed Nicotine in Smokers
- ClinicalTrials.gov ID
- NCT04488744
- Acronym / sponsor ID
- MS059
- Conditions
- Smoking Cessation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 28 Jul 2020 (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.
To establish a dose-effect curve for nicotine's abuse potential as a function of nicotine dose and delivery rate. Pulsed IV nicotine administration will be used as it closely matches nicotine delivery by inhaled tobacco use.
Detailed description
Both sub-studies will enroll male and female tobacco cigarette smokers. This study will examine the feasibility of the proposed study parameters in a total of 10 completers. In a crossover design, participants will be tested under 5 conditions: 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries). The main outcome measures will be self-report drug effects and urges to smoke cigarettes.
The investigators hypothesize that the abuse potential and alleviation of smoking urges are produced by nicotine as a function of nicotine dose and delivery rate.
This study is complete with 13 enrolled and 10 completers
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- placebo-controlled, mixed-design with nicotine dose as a between-subject and nicotine delivery rate as a within-subject factor.
| Arm | Type | Receives |
|---|---|---|
| nicotine infusion 0.2mg | Experimental | Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/snicotine infusion 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) The day order will be randomized over 5 days. |
| nicotine infusion 2.0mg | Experimental | Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), |
| nicotine infusion 1.0mg | Experimental | Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) |
| nicotine infuison 1.0mg | Experimental | Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries). |
| Saline | Placebo comparator | Drug: Nicotine 0.2mcg/kg/s and 1.0mcg/kg/ssaline delivered over 2minutes ,2.5minutes,10 minutes |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 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
- 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; and 6) for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
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 0.2mcg/kg/s and 1.0mcg/kg/sAlso: nicotine infusionNicotine infusion 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries). | Drug | Saline, nicotine infuison 1.0mg, nicotine infusion 0.2mg, nicotine infusion 1.0mg, nicotine infusion 2.0mg |
Primary outcome
Heart rate will be used to see the dose effect
Time frame: During nicotine infusion max of ten minutes
the dose-effect curves of nicotine dose and delivery rate in heart rate
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 20 Jul 2021.
- 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
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 0.2mcg/kg/s and 1.0mcg/kg/s in people with Smoking Cessation, 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 5 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 20 Jul 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 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?
Heart rate will be used to see the dose effect (time frame: During nicotine infusion max of ten minutes). 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 20 Jul 2021.