Nicotine and Pavlovian Bias

NCT06027723 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: UP-23-00575
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nicotine Vaping; Nicotine Dependence

Keywords

Nicotine

Outcome Measures

Primary Outcomes (1)

• 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).

  0 hours after using the vaping device (right after)

Study Arms (2)

Nicotine

EXPERIMENTAL

Participants will follow a standard vape protocol designed to deliver the approximate nicotine typically consumed from 1 cigarette (1.25 mg)

Drug: Nicotine

Placebo

PLACEBO COMPARATOR

Participants will follow a standard vape protocol that is equal inhalation to that used in the nicotine condition.

Other: Placebo

Interventions

Nicotine DRUG

Nicotine delivered through a vape

Nicotine

Placebo OTHER

Placebo nicotine-free vaping liquid delivered through a vape

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Currently pregnant, planning to become pregnant, or breastfeeding

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 34849626 BACKGROUND

• Guitart-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.

  PMID: 22529363 BACKGROUND

• Scholz 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.

  PMID: 35260787 BACKGROUND

• Swart 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.

  PMID: 28504638 BACKGROUND

MeSH Terms

Conditions

Vaping; Tobacco Use Disorder

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Smoking; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Veronika Sidorova

CONTACT

424-438-8597; sidorova@usc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Vapes will be color coded and data recorded by color. Correspondence between color and condition will be unblinded at completion.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Psychology

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: September 7, 2023
• Study Start: October 25, 2023
• Primary Completion: August 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after publication or 1 year after completion (whichever comes first)
• Access Criteria: open

Locations

US (1)