Acute and Chronic Nicotine Modulation of Reinforcement Learning

NCT01830842 | Completed Results DMC

• 1 other identifier: Pro00043890
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nicotine Addiction

Keywords

Nicotine; Smoking; Cigarettes; Reinforcement Learning; fMRI

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Study Arms (2)

Nicotine, placebo

PLACEBO COMPARATOR

Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion.

Drug: Nicotine polacrilex; Drug: Placebo

Nicotine withdrawal or satiety

OTHER

Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence

Other: satiety; Other: abstinence

Interventions

Nicotine polacrilex DRUG

nonsmokers will be measured following nicotine administration

Also known as: nicotine condition

Nicotine, placebo

Placebo DRUG

nonsmokers will be measured following placebo administration

Also known as: placebo condition

Nicotine, placebo

satiety OTHER

smokers will be measured in a smoking satiated condition

Also known as: smoking satiated condition

Nicotine withdrawal or satiety

abstinence OTHER

smokers will be measured following 24-hours of smoking abstinence

Also known as: smoking abstinence condition

Nicotine withdrawal or satiety

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Tobacco Use Cessation Devices; Natural Family Planning Methods

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Contraception; Reproductive Techniques

Results Point of Contact

• Title: Merideth Addicott
• Organization: University of Arkansas for Medical Sciences

MAddicott@uams.edu

501-526-8436

Study Officials

• Merideth A Addicott, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 12, 2013
• Study Start: February 1, 2014
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: December 19, 2017
• Results First Posted: December 19, 2017

Record last verified: 2017-11

Locations

US (1)