Back to results

Acute and Chronic Nicotine Modulation of Reinforcement Learning (NicLearning)

Primary Purpose

Nicotine Addiction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nicotine polacrilex

Placebo

satiety

abstinence

About this trial

This is an interventional basic science trial for Nicotine Addiction focused on measuring Nicotine, Smoking, Cigarettes, Reinforcement Learning, fMRI

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Other

Arm Label

Nicotine, placebo

Nicotine withdrawal or satiety

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01830842

First Posted

April 10, 2013

Last Updated

November 17, 2017

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT01830842

Brief Title

Acute and Chronic Nicotine Modulation of Reinforcement Learning

Acronym

NicLearning

Official Title

Acute and Chronic Nicotine Modulation of Reinforcement Learning

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

August 31, 2016 (Actual)

Study Completion Date

August 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Addiction

Keywords

Nicotine, Smoking, Cigarettes, Reinforcement Learning, fMRI

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Non-Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nicotine, placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Nicotine withdrawal or satiety

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nicotine polacrilex

Other Intervention Name(s)

nicotine condition

Intervention Description

nonsmokers will be measured following nicotine administration

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

placebo condition

Intervention Description

nonsmokers will be measured following placebo administration

Intervention Type

Other

Intervention Name(s)

satiety

Other Intervention Name(s)

smoking satiated condition

Intervention Description

smokers will be measured in a smoking satiated condition

Intervention Type

Other

Intervention Name(s)

abstinence

Other Intervention Name(s)

smoking abstinence condition

Intervention Description

smokers will be measured following 24-hours of smoking abstinence

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Merideth A Addicott, PhD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Acute and Chronic Nicotine Modulation of Reinforcement Learning

We'll reach out to this number within 24 hrs