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Acute and Chronic Nicotine Modulation of Reinforcement Learning (NicLearning)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01830842
First Posted: April 12, 2013
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  Purpose
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.

Condition Intervention
Nicotine Addiction Drug: Nicotine polacrilex Drug: Placebo Other: satiety Other: abstinence

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Acute and Chronic Nicotine Modulation of Reinforcement Learning

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • change in blood oxygen level dependent signal [ Time Frame: baseline, 3 hours post nicotine, 3 hours post placebo, change from nicotine to placebo, 24 hours post smoking cessation, smoking satiety, change from satiety to abstinence ]
    The acute and chronic effects of nicotine on the blood oxygen level dependent signal will be measured using functional magnetic resonance imaging.


Enrollment: 48
Study Start Date: February 2014
Study Completion Date: August 31, 2016
Primary Completion Date: August 31, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Nicotine, placebo
Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion.
Drug: Nicotine polacrilex
nonsmokers will be measured following nicotine administration
Other Name: nicotine condition
Drug: Placebo
nonsmokers will be measured following placebo administration
Other Name: placebo condition
Nicotine withdrawal or satiety
Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence
Other: satiety
smokers will be measured in a smoking satiated condition
Other Name: smoking satiated condition
Other: abstinence
smokers will be measured following 24-hours of smoking abstinence
Other Name: smoking abstinence condition

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria for all subjects:

  1. generally healthy
  2. between the ages of 18-55
  3. right-handed

Inclusion criteria for nonsmokers:

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

Inclusion criteria for smokers

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

Exclusion Criteria:

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830842


Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Merideth A Addicott, PhD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01830842     History of Changes
Other Study ID Numbers: Pro00043890
First Submitted: April 10, 2013
First Posted: April 12, 2013
Last Update Posted: October 17, 2017
Last Verified: September 2016

Keywords provided by Duke University:
Nicotine
Smoking
Cigarettes
Reinforcement Learning
fMRI

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action