Clinical trial

Effects of Acute Nicotine Administration on Motivational Mechanisms

Name
UP-23-00575
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 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.
Trial arms
Trial start
2023-10-25
Estimated PCD
2024-08-31
Trial end
2024-10-31
Status
Recruiting
Phase
Early phase I
Treatment
Nicotine
Nicotine delivered through a vape
Arms:
Nicotine
Placebo
Placebo nicotine-free vaping liquid delivered through a vape
Arms:
Placebo
Size
40
Primary endpoint
Levels of Pavlovian Bias measured through a version of the Go/No-Go task
0 hours after using the vaping device (right after)
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.\n\nAfter 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.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Vapes will be color coded and data recorded by color. Correspondence between color and condition will be unblinded at completion.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-11-09

1 organization

1 product

2 indications

Product
Nicotine
Indication
Nicotine Vaping