Acute and Chronic Nicotine Modulation of Reinforcement Learning

NCT ID: NCT01830842

Last Updated: 2017-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-08-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Nicotine, placebo

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

Group Type: PLACEBO_COMPARATOR

Nicotine polacrilex

Intervention Type: DRUG

nonsmokers will be measured following nicotine administration

Placebo

Intervention Type: DRUG

nonsmokers will be measured following placebo administration

Nicotine withdrawal or satiety

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

Group Type: OTHER

satiety

Intervention Type: OTHER

smokers will be measured in a smoking satiated condition

abstinence

Intervention Type: OTHER

smokers will be measured following 24-hours of smoking abstinence

Interventions

Nicotine polacrilex

nonsmokers will be measured following nicotine administration

Intervention Type: DRUG

Placebo

nonsmokers will be measured following placebo administration

Intervention Type: DRUG

satiety

smokers will be measured in a smoking satiated condition

Intervention Type: OTHER

abstinence

smokers will be measured following 24-hours of smoking abstinence

Intervention Type: OTHER

Other Intervention Names

nicotine condition; placebo condition; smoking satiated condition; smoking abstinence condition

Eligibility Criteria

Inclusion Criteria

1. generally healthy

2. between the ages of 18-55

3. right-handed

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Merideth A Addicott, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00043890

Identifier Type: -

Identifier Source: org_study_id