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Completed

NCT Number: NCT01830842

Acute and Chronic Nicotine Modulation of Reinforcement Learning

The purpose of this study is to use functional magnetic resonance imaging (fMRI) to investigate the acute and chronic effects of nicotine on motivational behavior and prediction error-related neural activation. Nonsmokers (n = 24) and smokers (n = 24) will undergo fMRI scans on two separate occasions while performing a decision-making task that will elicit prediction error signals in the mesocorticolimbic pathway of the brain. Nonsmokers will be scanned once following an acute dose of nicotine and once following placebo administration. Smokers will be scanned once following smoking as usual and once following 24-hours of smoking abstinence, in order to measure the effects of nicotine withdrawal. The study team hypothesizes that acute nicotine will increase the prediction error signal in nonsmokers compared to placebo, and that nicotine withdrawal will decrease the prediction error signal in smokers compared to the normal satiated condition. Furthermore, nonsmokers (during the placebo condition) will have greater prediction error activation than smokers (during the satiated condition). The results of this study will inform whether the initiation and maintenance of smoking behavior could be facilitated by the effects of nicotine on reinforcement learning.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for all subjects:

  • generally healthy
  • between the ages of 18-55
  • right-handed

Inclusion criteria

for nonsmokers:

  • smoked < 50 cigarettes of a brand delivering ≥ 0.5 mg nicotine (FTC method)
  • have not smoked in ≥ 6 months
  • afternoon expired CO concentration ≤ 5 ppm and/or morning urinary NicAlert < 100 ng/ml

Inclusion criteria

for smokers

  • smoke ≥ 10 cigarettes/day of a brand delivering ≥ 0.5 mg nicotine (FTC method)
  • smoked ≥ 2 years
  • afternoon expired CO concentrations ≥ 10 ppm and/or morning urinary NicAlert > 100 ng/ml

Exclusion criteria

  • inability to attend all required experimental sessions
  • significant health problems (e.g., current and uncontrolled liver, lung, or heart problems, current or past seizure disorder, serious head trauma)
  • lifetime diagnosis of Axis I psychiatric disorders (e.g., depression, anxiety disorder, schizophrenia)
  • meet DSM-V criteria for past or current substance dependence other than nicotine
  • use of psychoactive medications as indicated by self-report
  • use of smokeless tobacco, nicotine replacement therapy, or desire to change smoking behavior while in the study
  • positive urine drug screen for illicit drugs or positive breath alcohol concentration
  • presence of conditions that would make MRI unsafe
  • having vision that cannot be corrected to 20/40
  • among women, nursing or a positive pregnancy test
  • inability to achieve learning criteria in training session

Treatment and study plan

Nicotine polacrilex

Drug

nonsmokers will be measured following nicotine administration

Other names: nicotine condition

Placebo

Drug

nonsmokers will be measured following placebo administration

Other names: placebo condition

Satiety

Other

smokers will be measured in a smoking satiated condition

Other names: smoking satiated condition

abstinence

Other

smokers will be measured following 24-hours of smoking abstinence

Other names: smoking abstinence condition

Primary outcomes

  1. Change in Blood Oxygen Level Dependent (BOLD) Signal in Dorsomedial Prefrontal Cortex

    Time frame: Nonsmokers: post nicotine and post placebo. Smokers: 24 hours smoking abstinence or smoking satiety

    The acute and chronic effects of nicotine on the blood oxygen level dependent signal will be measured using functional magnetic resonance imaging. Reward-cue related BOLD signal on an outcome expectation task.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: NicLearning

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 12, 2013
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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