Acute and Chronic Nicotine Modulation of Reinforcement Learning (NicLearning)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01830842
First received: April 10, 2013
Last updated: July 2, 2014
Last verified: July 2014
  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 Blind (Subject, 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 ] [ Designated as safety issue: No ]
    The acute and chronic effects of nicotine on the blood oxygen level dependent signal will be measured using functional magnetic resonance imaging.


Estimated Enrollment: 48
Study Start Date: February 2014
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01830842

Contacts
Contact: Merideth A Addicott, PhD 919-684-5237 merideth.addicott@duke.edu
Contact: Rachel Kozink, BS 919-668-2963 rachel.kozink@dm.duke.edu

Locations
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Merideth Addicott, PhD    919-684-5237    merideth.addicott@duke.edu   
Principal Investigator: Merideth A Addicott, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Merideth A Addicott, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01830842     History of Changes
Other Study ID Numbers: Pro00043890
Study First Received: April 10, 2013
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014