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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine, placebo | Placebo Comparator | Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion. |
|
| Nicotine withdrawal or satiety | Other | Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine polacrilex | Drug | nonsmokers will be measured following nicotine administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Inclusion criteria for all subjects:
Inclusion criteria for nonsmokers:
Inclusion criteria for smokers
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merideth A Addicott, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine, Placebo | Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion. Nicotine polacrilex: nonsmokers will be measured following nicotine administration Placebo: nonsmokers will be measured following placebo administration |
| FG001 | Nicotine Withdrawal or Satiety | Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence satiety: smokers will be measured in a smoking satiated condition abstinence: smokers will be measured following 24-hours of smoking abstinence |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine, Placebo | Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion. Nicotine polacrilex: nonsmokers will be measured following nicotine administration Placebo: nonsmokers will be measured following placebo administration |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects who did not follow MRI task instructions, or those with > 3 mm of movement, were excluded from the analyses. | Posted | Mean | Standard Deviation | percentage of BOLD signal | Nonsmokers: post nicotine and post placebo. Smokers: 24 hours smoking abstinence or smoking satiety |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nicotine, Placebo | Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion. Nicotine polacrilex: nonsmokers will be measured following nicotine administration Placebo: nonsmokers will be measured following placebo administration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merideth Addicott | University of Arkansas for Medical Sciences | 501-526-8436 | 501 | MAddicott@uams.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D012252 | Natural Family Planning Methods |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003267 | Contraception |
| D012099 | Reproductive Techniques |
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| Placebo | Drug | nonsmokers will be measured following placebo administration |
|
|
| satiety | Other | smokers will be measured in a smoking satiated condition |
|
|
| abstinence | Other | smokers will be measured following 24-hours of smoking abstinence |
|
|
| Nicotine Withdrawal or Satiety |
Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence satiety: smokers will be measured in a smoking satiated condition abstinence: smokers will be measured following 24-hours of smoking abstinence |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Smokers | Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence satiety: smokers will be measured in a smoking satiated condition abstinence: smokers will be measured following 24-hours of smoking abstinence |
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Nicotine Withdrawal or Satiety | Smokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence satiety: smokers will be measured in a smoking satiated condition abstinence: smokers will be measured following 24-hours of smoking abstinence | 0 | 24 | 0 | 24 |
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