Recruiting
Early Phase 1

Nicotine

Sponsor:

University of Southern California

Code:

NCT06027723

Conditions

Nicotine Vaping

Nicotine Dependence

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Nicotine

Placebo

Study Details

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

Study ID

NCT06027723

Start date

Oct 25, 2023

Status verified date

Nov, 2023

Completion date

Oct 31, 2024

Anticipated

Primary completion date

Aug 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Currently pregnant, planning to become pregnant, or breastfeeding

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Nicotine

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

placebo comparator: Placebo

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

Interventions

Nicotine

Nicotine delivered through a vape

Placebo

Placebo nicotine-free vaping liquid delivered through a vape

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) ]

Central Contacts and Locations

Central contacts

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90089

Contacts

More Information

Sponsor

University of Southern California

Last update posted

Nov 9, 2023

Last verified

Nov, 2023

Keywords

  • Nicotine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2023-11-09.