Nicotine VapingEarly Phase 1NCT06027723
Nicotine and Pavlovian Bias
A Early Phase 1 study testing Nicotine in people with Nicotine Vaping and Nicotine Dependence, run by University of Southern California at 1 site in United States.
Trial summary
Nicotine remains a major cause of health problems in the US and around the world. Insight into the behavioral changes induced by nicotine use may help advance the understanding of the mechanisms underlying the maintenance of nicotine addiction and thus the important factors involved in the quitting process. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Vaping, Nicotine Dependence
- What is being tested?
- Nicotine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to 31 Oct 2024
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 21 years old
- Current nicotine user (at least monthly use over the past 3 months)
- Reported willingness to abstain from all nicotine for at least 10 hours prior to the two lab visits
- English Language Competency
Who cannot join
- Currently pregnant, planning to become pregnant, or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90089
John R Monterosso, 310-709-9322, johnrmon@usc.edu
About this study
Official title: Effects of Acute Nicotine Administration on Motivational Mechanisms
Nicotine remains a major cause of health problems in the US and around the world. Insight into the behavioral changes induced by nicotine use may help advance the understanding of the mechanisms underlying the maintenance of nicotine addiction and thus the important factors involved in the quitting process. Pavlovian bias is a phenomenon that includes an approach tendency toward rewarding cues and an action withdrawal tendency in response to punishments. This phenomenon may be particularly relevant to nicotine users. The current study will use an experimental, within-subjects, repeated-measured design to investigate whether acute nicotine administration influences individual Pavlovian bias in nicotine users. By recruiting participants from the University of Southern California (USC) community and contacting participants of previous nicotine-related studies of the Addiction and Self-Control Laboratory at USC, the investigators will enroll forty adult nicotine users in the study. Participants will come to the lab twice after a 10-hour nicotine fast. At each lab visit, participants will undergo a vaping session prior to completing the study tasks. The content of the e-liquid in the vape will vary by nicotine content: the vape will either contain nicotine or not. Subsequent to vaping, participants will complete a version of the Go/No-Go task which will measure their individual levels of Pavlovian bias. The investigators will compare performance on the task across the two conditions within each participant: on- and off- nicotine, after controlling for nicotine withdrawal and nicotine tolerance. Based on past research on nicotine, the researchers anticipate that acute nicotine administration will be associated with higher levels of Pavlovian bias, compared to the off-nicotine condition. Specifically, two patterns are expected to arise: a higher likelihood of making a go-response in the "win reward" condition and a higher likelihood of making a no-go response in the "avoid losing" condition, regardless of whether it is a "go" or "no-go" trial. Participants will also complete a measure of their working memory capacity. The investigators will conduct exploratory analyses for the relationship between different nicotine conditions and working memory capacity.
Read the detailed description
Nicotine remains a major cause of health problems in the US and around the world. Insight into the behavioral changes induced by nicotine use may help advance the understanding of the mechanisms underlying the maintenance of nicotine addiction and thus the important factors involved in the quitting process. Pavlovian bias is a phenomenon that includes an approach tendency toward rewarding cues and a tendency to withdraw from action in response to punishments. This phenomenon may be particularly relevant in the context of addiction and impulsive behavior patterns. The current project proposes to examine Pavlovian bias in the context of nicotine use. Specifically, the study aims to explore whether acute nicotine administration affects Pavlovian bias among nicotine users.
Previous studies suggest that Pavlovian bias is a universal phenomenon, but that some individuals are better at overcoming it. Nicotine has been shown to make individuals more sensitive to cues that predict loss and reward. Therefore, it is hypothesized that nicotine will increase individuals' existing Pavlovian bias levels.
Moreover, understanding whether nicotine indeed does impact Pavlovian bias may provide insight into ways in which this bias affects nicotine addiction. For example, nicotine use commonly coexists with other substance use behaviors. If nicotine acutely increases Pavlovian bias, this mechanism could partially explain the general increase of impulsive behaviors among nicotine users.
Purpose/Objectives/Aims/Research Questions The primary aim is to explore the effects of acute nicotine administration on Pavlovian bias. After showing eligibility to take part in the study, participants will come to the lab twice, each after a (self-reported) 10-hour abstinence from nicotine. After completing assessments of nicotine withdrawal and nicotine tolerance, participants will complete a standardized vaping bout, either with a vape with nicotine ("on-nicotine") or a denicotinized one ("off-nicotine"). Although the exact dose of inhaled nicotine depends on the particular puff topography of participants, the standardized vape protocol is designed to deliver approximately 2mg of nicotine. Participants will be encouraged to stop if they feel they are on the verge of having any negative nicotine response (e.g., feeling some nausea). Pavlovian bias will then be assessed via performance on a version of the Go/No-Go task. Specifically, the investigators will record participants' response accuracy on each of the four trials: go-to-win-reward, no-go-to-win-reward, go-to-avoid-losing, and no-go-to-avoid-losing. Finally, participants will complete a measure of their working memory capacity. The researchers will compare performance on the task across the two conditions within each participant: on- and off- nicotine, after controlling for nicotine withdrawal and nicotine tolerance. The investigators will also conduct exploratory analyses to determine whether participants' working memory capacity is affected by the different nicotine conditions.
Aim: Examine the effects of acute nicotine administration on Pavlovian bias. The investigators will explore the effects of acute nicotine on "go-bias" and "no-go bias." They anticipate that some level of Pavlovian bias will be observed across both sessions, on- and off- nicotine. Two patterns are expected to arise: a higher likelihood of making a go-response in the "win reward" condition and a higher likelihood of making a no-go response in the "avoid losing" condition, regardless of whether it is a "go" or "no-go" trial. However, after acute nicotine administration, participants will exhibit higher levels of Pavlovian bias, compared to the off-nicotine condition.
Understanding whether nicotine indeed does impact Pavlovian bias may provide insight into ways in which this bias affects nicotine addiction.
- Conditions
- Nicotine Vaping, Nicotine Dependence
- Being tested
- Nicotine, Placebo
- Keywords
- Nicotine
- Medical subject headings
- Vaping, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
Nicotine delivered through a vape
PlaceboOther
Placebo nicotine-free vaping liquid delivered through a vape
| Study group | Role | What they receive |
|---|---|---|
| Nicotine | Experimental | Participants will follow a standard vape protocol designed to deliver the approximate nicotine typically consumed from 1 cigarette (1.25 mg) Receives: Drug: Nicotine |
| Placebo | Placebo comparator | Participants will follow a standard vape protocol that is equal inhalation to that used in the nicotine condition. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Pavlovian Bias measured through a version of the Go/No-Go task
Participants will complete a version of the Go/No-Go task, which allows to measure individual levels of Pavlovian bias. Pavlovian bias is a phenomenon that includes an approach tendency toward rewarding cues and a tendency to withdraw from action in response to punishments. In the task, participants choose a response (go or no-go) for various visual cues which have specific response-dependent outcomes.The Go/No-Go task design allows to collect participants' task accuracy scores (task accuracy will signify how many correct cue-dependent responses participants make).
Measured: 0 hours after using the vaping device (right after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start25 Oct 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nicotine VapingStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Parallel groups
- Model description
- The participant will be randomized to receive either the regular vape with nicotine or the placebo nicotine vape first and will complete a standardized vaping session with the assigned vape. Each participant will receive both vape conditions, one at each laboratory visit. Moreover, they will not know the order of administration. After completing the vaping session, participants will be instructed on how to complete a version of the Go/No-Go task. They will see geometrical shapes on the screen, each of which will signal a particular trial type: go-win-win-reward, no-go-to-win-reward, go-to-avoid-losing, or no-go-to-avoid-losing. Participants will be explicitly instructed that the color of the cue edge will correspond to a specific trial: green will represent a "win reward" condition and red will represent an "avoid losing" condition.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Robert Monterosso, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027723
- Sponsor's protocol ID
- UP-23-00575
- Status last verified
- Nov 2023
- First submitted
- 16 Aug 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will post data on Open Science Framework
Publications
Algermissen J, Swart JC, Scheeringa R, Cools R, den Ouden HEM. Striatal BOLD and Midfrontal Theta Power Express Motivation for Action. Cereb Cortex. 2022 Jul 12;32(14):2924-2942. doi: 10.1093/cercor/bhab391.
PubMed 34849626Guitart-Masip M, Chowdhury R, Sharot T, Dayan P, Duzel E, Dolan RJ. Action controls dopaminergic enhancement of reward representations. Proc Natl Acad Sci U S A. 2012 May 8;109(19):7511-6. doi: 10.1073/pnas.1202229109. Epub 2012 Apr 23.
PubMed 22529363Scholz V, Hook RW, Kandroodi MR, Algermissen J, Ioannidis K, Christmas D, Valle S, Robbins TW, Grant JE, Chamberlain SR, den Ouden HEM. Cortical dopamine reduces the impact of motivational biases governing automated behaviour. Neuropsychopharmacology. 2022 Jul;47(8):1503-1512. doi: 10.1038/s41386-022-01291-8. Epub 2022 Mar 8.
PubMed 35260787Swart JC, Frobose MI, Cook JL, Geurts DE, Frank MJ, Cools R, den Ouden HE. Catecholaminergic challenge uncovers distinct Pavlovian and instrumental mechanisms of motivated (in)action. Elife. 2017 May 15;6:e22169. doi: 10.7554/eLife.22169.
PubMed 28504638
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Nicotine Administration on Motivational Mechanisms
- ClinicalTrials.gov ID
- NCT06027723
- Acronym / sponsor ID
- UP-23-00575
- Conditions
- Nicotine Vaping, Nicotine Dependence
- Keywords
- Nicotine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 7 Sep 2023 (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.
Nicotine remains a major cause of health problems in the US and around the world. Insight into the behavioral changes induced by nicotine use may help advance the understanding of the mechanisms underlying the maintenance of nicotine addiction and thus the important factors involved in the quitting process. Pavlovian bias is a phenomenon that includes an approach tendency toward rewarding cues and an action withdrawal tendency in response to punishments. This phenomenon may be particularly relevant to nicotine users. The current study will use an experimental, within-subjects, repeated-measured design to investigate whether acute nicotine administration influences individual Pavlovian bias in nicotine users. By recruiting participants from the University of Southern California (USC) community and contacting participants of previous nicotine-related studies of the Addiction and Self-Control Laboratory at USC, the investigators will enroll forty adult nicotine users in the study. Participants will come to the lab twice after a 10-hour nicotine fast. At each lab visit, participants will undergo a vaping session prior to completing the study tasks. The content of the e-liquid in the vape will vary by nicotine content: the vape will either contain nicotine or not. Subsequent to vaping, participants will complete a version of the Go/No-Go task which will measure their individual levels of Pavlovian bias. The investigators will compare performance on the task across the two conditions within each participant: on- and off- nicotine, after controlling for nicotine withdrawal and nicotine tolerance. Based on past research on nicotine, the researchers anticipate that acute nicotine administration will be associated with higher levels of Pavlovian bias, compared to the off-nicotine condition. Specifically, two patterns are expected to arise: a higher likelihood of making a go-response in the "win reward" condition and a higher likelihood of making a no-go response in the "avoid losing" condition, regardless of whether it is a "go" or "no-go" trial. Participants will also complete a measure of their working memory capacity. The investigators will conduct exploratory analyses for the relationship between different nicotine conditions and working memory capacity.
Detailed description
Nicotine remains a major cause of health problems in the US and around the world. Insight into the behavioral changes induced by nicotine use may help advance the understanding of the mechanisms underlying the maintenance of nicotine addiction and thus the important factors involved in the quitting process. Pavlovian bias is a phenomenon that includes an approach tendency toward rewarding cues and a tendency to withdraw from action in response to punishments. This phenomenon may be particularly relevant in the context of addiction and impulsive behavior patterns. The current project proposes to examine Pavlovian bias in the context of nicotine use. Specifically, the study aims to explore whether acute nicotine administration affects Pavlovian bias among nicotine users.
Previous studies suggest that Pavlovian bias is a universal phenomenon, but that some individuals are better at overcoming it. Nicotine has been shown to make individuals more sensitive to cues that predict loss and reward. Therefore, it is hypothesized that nicotine will increase individuals' existing Pavlovian bias levels.
Moreover, understanding whether nicotine indeed does impact Pavlovian bias may provide insight into ways in which this bias affects nicotine addiction. For example, nicotine use commonly coexists with other substance use behaviors. If nicotine acutely increases Pavlovian bias, this mechanism could partially explain the general increase of impulsive behaviors among nicotine users.
Purpose/Objectives/Aims/Research Questions The primary aim is to explore the effects of acute nicotine administration on Pavlovian bias. After showing eligibility to take part in the study, participants will come to the lab twice, each after a (self-reported) 10-hour abstinence from nicotine. After completing assessments of nicotine withdrawal and nicotine tolerance, participants will complete a standardized vaping bout, either with a vape with nicotine ("on-nicotine") or a denicotinized one ("off-nicotine"). Although the exact dose of inhaled nicotine depends on the particular puff topography of participants, the standardized vape protocol is designed to deliver approximately 2mg of nicotine. Participants will be encouraged to stop if they feel they are on the verge of having any negative nicotine response (e.g., feeling some nausea). Pavlovian bias will then be assessed via performance on a version of the Go/No-Go task. Specifically, the investigators will record participants' response accuracy on each of the four trials: go-to-win-reward, no-go-to-win-reward, go-to-avoid-losing, and no-go-to-avoid-losing. Finally, participants will complete a measure of their working memory capacity. The researchers will compare performance on the task across the two conditions within each participant: on- and off- nicotine, after controlling for nicotine withdrawal and nicotine tolerance. The investigators will also conduct exploratory analyses to determine whether participants' working memory capacity is affected by the different nicotine conditions.
Aim: Examine the effects of acute nicotine administration on Pavlovian bias. The investigators will explore the effects of acute nicotine on "go-bias" and "no-go bias." They anticipate that some level of Pavlovian bias will be observed across both sessions, on- and off- nicotine. Two patterns are expected to arise: a higher likelihood of making a go-response in the "win reward" condition and a higher likelihood of making a no-go response in the "avoid losing" condition, regardless of whether it is a "go" or "no-go" trial. However, after acute nicotine administration, participants will exhibit higher levels of Pavlovian bias, compared to the off-nicotine condition.
Understanding whether nicotine indeed does impact Pavlovian bias may provide insight into ways in which this bias affects nicotine addiction.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The participant will be randomized to receive either the regular vape with nicotine or the placebo nicotine vape first and will complete a standardized vaping session with the assigned vape. Each participant will receive both vape conditions, one at each laboratory visit. Moreover, they will not know the order of administration. After completing the vaping session, participants will be instructed on how to complete a version of the Go/No-Go task. They will see geometrical shapes on the screen, each of which will signal a particular trial type: go-win-win-reward, no-go-to-win-reward, go-to-avoid-losing, or no-go-to-avoid-losing. Participants will be explicitly instructed that the color of the cue edge will correspond to a specific trial: green will represent a "win reward" condition and red will represent an "avoid losing" condition.
| Arm | Type | Receives |
|---|---|---|
| Nicotine | Experimental | Drug: NicotineParticipants will follow a standard vape protocol designed to deliver the approximate nicotine typically consumed from 1 cigarette (1.25 mg) |
| Placebo | Placebo comparator | Other: PlaceboParticipants will follow a standard vape protocol that is equal inhalation to that used in the nicotine condition. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 21 years old
- Current nicotine user (at least monthly use over the past 3 months)
- Reported willingness to abstain from all nicotine for at least 10 hours prior to the two lab visits
- English Language Competency
Key exclusion criteria (1 listed)
- Currently pregnant, planning to become pregnant, or breastfeeding
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 |
|---|---|---|
| NicotineNicotine delivered through a vape | Drug | Nicotine |
| PlaceboPlacebo nicotine-free vaping liquid delivered through a vape | Other | Placebo |
Primary outcome
Levels of Pavlovian Bias measured through a version of the Go/No-Go task
Time frame: 0 hours after using the vaping device (right after)
Participants will complete a version of the Go/No-Go task, which allows to measure individual levels of Pavlovian bias. Pavlovian bias is a phenomenon that includes an approach tendency toward rewarding cues and a tendency to withdraw from action in response to punishments. In the task, participants choose a response (go or no-go) for various visual cues which have specific response-dependent outcomes.The Go/No-Go task design allows to collect participants' task accuracy scores (task accuracy will signify how many correct cue-dependent responses participants make).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Background: PubMed 34849626Algermissen J, Swart JC, Scheeringa R, Cools R, den Ouden HEM. Striatal BOLD and Midfrontal Theta Power Express Motivation for Action. Cereb Cortex. 2022 Jul 12;32(14):2924-2942. doi: 10.1093/cercor/bhab391.
- Background: PubMed 22529363Guitart-Masip M, Chowdhury R, Sharot T, Dayan P, Duzel E, Dolan RJ. Action controls dopaminergic enhancement of reward representations. Proc Natl Acad Sci U S A. 2012 May 8;109(19):7511-6. doi: 10.1073/pnas.1202229109. Epub 2012 Apr 23.
- Background: PubMed 35260787Scholz V, Hook RW, Kandroodi MR, Algermissen J, Ioannidis K, Christmas D, Valle S, Robbins TW, Grant JE, Chamberlain SR, den Ouden HEM. Cortical dopamine reduces the impact of motivational biases governing automated behaviour. Neuropsychopharmacology. 2022 Jul;47(8):1503-1512. doi: 10.1038/s41386-022-01291-8. Epub 2022 Mar 8.
- Background: PubMed 28504638Swart JC, Frobose MI, Cook JL, Geurts DE, Frank MJ, Cools R, den Ouden HE. Catecholaminergic challenge uncovers distinct Pavlovian and instrumental mechanisms of motivated (in)action. Elife. 2017 May 15;6:e22169. doi: 10.7554/eLife.22169.
- Individual participant dataSharing planned: Yes. Will post data on Open Science Framework
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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.
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 in people with Nicotine Vaping and Nicotine Dependence, run by University of Southern California 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 1 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: status not confirmed, as of the sponsor's last update on 9 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronika Sidorova (424-438-8597, sidorova@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of Pavlovian Bias measured through a version of the Go/No-Go task (time frame: 0 hours after using the vaping device (right after)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06027723, which also lists 4 linked publications.
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 9 Nov 2023.