Nicotine AddictionNicLearningNCT01830842
Acute and Chronic Nicotine Modulation of Reinforcement Learning
A study testing Nicotine polacrilex, satiety and abstinence in people with Nicotine Addiction, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Addiction
- What is being tested?
- Nicotine polacrilex, satiety and abstinence
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 31 Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Nicotine polacrilex, Placebo, satiety, abstinence
- Keywords
- Nicotine, Smoking, Cigarettes, Reinforcement Learning, fMRI
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine polacrilexDrug
Also called nicotine condition
nonsmokers will be measured following nicotine administration
PlaceboDrug
Also called placebo condition
nonsmokers will be measured following placebo administration
satietyOther
Also called smoking satiated condition
smokers will be measured in a smoking satiated condition
abstinenceOther
Also called smoking abstinence condition
smokers will be measured following 24-hours of smoking abstinence
| Study group | Role | What they receive |
|---|---|---|
| Nicotine, placebo | Placebo comparator | Nonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion. Receives: 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 Receives: Other: satiety; Other: abstinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Nonsmokers: post nicotine and post placebo. Smokers: 24 hours smoking abstinence or smoking satiety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startFeb 2014
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine AddictionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merideth A Addicott, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830842
- Sponsor's protocol ID
- Pro00043890
- Acronym
- NicLearning
- Status last verified
- Nov 2017
- First submitted
- 10 Apr 2013
- Last updated
- 19 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Nicotine Modulation of Reinforcement Learning
- ClinicalTrials.gov ID
- NCT01830842
- Acronym / sponsor ID
- NicLearning / Pro00043890
- Conditions
- Nicotine Addiction
- Keywords
- Nicotine, Smoking, Cigarettes, Reinforcement Learning, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 12 Apr 2013 (estimated)
- Results
- Posted 19 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine, placebo | Placebo comparator | Drug: Nicotine polacrilex, Drug: PlaceboNonsmokers will be measured following a nicotine polacrilex lozenge (2mg) on one occasion and placebo on another occasion. |
| Nicotine withdrawal or satiety | Other | Other: satiety, Other: abstinenceSmokers will be measured in a normal satiated condition and following 24-hours of smoking abstinence |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine polacrilexAlso: nicotine conditionnonsmokers will be measured following nicotine administration | Drug | Nicotine, placebo |
| PlaceboAlso: placebo conditionnonsmokers will be measured following placebo administration | Drug | Nicotine, placebo |
| satietyAlso: smoking satiated conditionsmokers will be measured in a smoking satiated condition | Other | Nicotine withdrawal or satiety |
| abstinenceAlso: smoking abstinence conditionsmokers will be measured following 24-hours of smoking abstinence | Other | Nicotine withdrawal or satiety |
Primary outcome
Change in Blood Oxygen Level Dependent (BOLD) Signal in Dorsomedial Prefrontal Cortex
Time frame: Nonsmokers: post nicotine and post placebo. Smokers: 24 hours smoking abstinence or smoking satiety
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merideth A Addicott, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine polacrilex, satiety and abstinence in people with Nicotine Addiction, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Oxygen Level Dependent (BOLD) Signal in Dorsomedial Prefrontal Cortex (time frame: Nonsmokers: post nicotine and post placebo. Smokers: 24 hours smoking abstinence or smoking satiety). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.