SmokingNCT01123668
Neuroimaging of Smokers With and Without Attention Deficit Hyperactivity Disorder (ADHD)
An observational study of Smoking and ADHD, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how nicotine, withdrawal from nicotine, and methylphenidate (a drug used for the treatment of ADHD) affect the brain of smokers with and without ADHD while doing tasks in an functional Magnetic Resonance Imaging scanner. Study Hypotheses: 1. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 120 voluntary participants to yield 40 Adult Regular Smokers, including 20 diagnosed with ADHD and 20 comparison controls.
Who may be able to join
- generally healthy, between the ages of 18-50yrs,
- smoking at least 10 cigarettes/day of a brand delivering ≥0.5 mg nicotine according to the standard Federal Trade Commission (FTC) method,
- an expired Carbon Monoxide concentration of at least 10ppm (to confirm inhalation) or a positive urine cotinine test (Nicalert ™) of 3 or greater,
- no interest in quitting smoking as measured by self-report,
- right-handed as measured by a three item scale used in our laboratory.
Who cannot join
- unable to attend all required experimental sessions,
- have significant health problems (e.g., chronic hypertension, emphysema, seizure disorders, history of significant heart problems),
- use of psychoactive medications with the exception of ADHD pharmacotherapies among ADHD diagnosed participants (see washout procedures below)
- use of smokeless tobacco
- current or past year alcohol or drug abuse,
- use of illegal drugs as measured by urine drug screen or self report
Show all 9Show fewer
- current use of nicotine replacement therapy or other smoking cessation treatment,
- presence of conditions that would make MRI unsafe (e.g., pacemaker, metal objects in the body, IUD),
- if they are female and pregnant or plan on becoming pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Child and Family Study Center//Duke Health Behavior Neuroscience Research Program
Durham, North Carolina, 27705
About this study
Official title: Neuropharmacology of Response Inhibition in Comorbid ADHD and Nicotine Dependence
The purpose of this study is to evaluate how nicotine, withdrawal from nicotine, and methylphenidate (a drug used for the treatment of ADHD) affect the brain of smokers with and without ADHD while doing tasks in an functional Magnetic Resonance Imaging scanner.
Study Hypotheses:
- compared to non-ADHD smokers, smokers with ADHD will exhibit greater abstinence-induced decrements in response inhibition performance and reward and greater concomitant disruptions of brain activity
- administration of MPH to abstinent smokers will ameliorate response inhibition performance and reward deficits and task-related brain activation and this effect will be greater among ADHD smokers
- genetic markers of dopamine neurotransmission will moderate abstinence- and MPH - induced changes in task-related brain activation across tasks.
Read the detailed description
Individuals diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) smoke more than the general population, initiate use at a younger age, and report more difficulty trying to quit. The overarching goal of the present application is to use neuroimaging, neuropharmacological and molecular genetic techniques to study the neurobiological basis of abstinence-induced deficits in response inhibition in ADHD and non-ADHD smokers. Twenty smokers with ADHD and 20 smokers without ADHD will undergo imaging during a Go/No-Go task under the following conditions: 1) smoking as usual, 2) 24 hr smoking abstinence, and 3) 24 hr smoking abstinence + methylphenidate (MPH). We hypothesize that compared to smoking as usual, 24 hr smoking abstinence will result in decrements in response inhibition and disruption of task-related brain activation. These effects will be greater in ADHD as compared to non-ADHD smokers. We further hypothesize that MPH administration during abstinence will restore performance and brain indices of response inhibition and that the magnitude of the effect of MPH will be greater among smokers with ADHD. In addition to the above aims, we will preliminarily evaluate the moderating effects of the dopamine receptor D4 7-repeat allele on task-related brain activation following smoking abstinence and MPH administration.
During the study, 101 subjects signed consents and 38 subjects completed the study.
- Keywords
- Smoking, ADHD, Nicotine, Methylphenidate, function Magnetic Resonance Imaging, Neurobiological basis of abstinence-induced deficits in response inhibition
- Medical subject headings
- Smoking, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ADHD and non-ADHD Smokers | Those that are defined as regular smokers (10 cigarettes/day or Carbon Monoxide reading of 10 ppm). The group will then be split into those diagnosed with ADHD/ADD and controls for comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of smoking abstinence on response inhibition brain function in smokers with and without ADHD.
Smokers will undergo three functional Magnetic Resonance Image scanning sessions while performing a task that measures response inhibition (Go/Go/No-Go task) Scanning will take place in the following conditions: smoking as usual + placebo pill, 24 hr smoking abstinence + placebo pill and 24 hr abstinence + methylphenidate (MPH). Methylphenidate is a dopamine reuptake inhibitor and its administration will allow us to evaluate the role of dopamine neurotransmission on response inhibition in the context of smoking abstinence.
Measured: July 2009 through December 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startJul 2009
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Francis J McClernon, Ph.D., Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123668
- Sponsor's protocol ID
- Pro00009085
- Other IDs
- 1R01DA024838-01A1
- Status last verified
- Aug 2014
- First submitted
- 12 May 2010
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropharmacology of Response Inhibition in Comorbid ADHD and Nicotine Dependence
- ClinicalTrials.gov ID
- NCT01123668
- Acronym / sponsor ID
- Pro00009085
- Keywords
- Smoking, ADHD, Nicotine, Methylphenidate, function Magnetic Resonance Imaging, Neurobiological basis of abstinence-induced deficits in response inhibition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2009
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Not posted in the source record
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 evaluate how nicotine, withdrawal from nicotine, and methylphenidate (a drug used for the treatment of ADHD) affect the brain of smokers with and without ADHD while doing tasks in an functional Magnetic Resonance Imaging scanner.
Study Hypotheses:
- compared to non-ADHD smokers, smokers with ADHD will exhibit greater abstinence-induced decrements in response inhibition performance and reward and greater concomitant disruptions of brain activity
- administration of MPH to abstinent smokers will ameliorate response inhibition performance and reward deficits and task-related brain activation and this effect will be greater among ADHD smokers
- genetic markers of dopamine neurotransmission will moderate abstinence- and MPH - induced changes in task-related brain activation across tasks.
Detailed description
Individuals diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) smoke more than the general population, initiate use at a younger age, and report more difficulty trying to quit. The overarching goal of the present application is to use neuroimaging, neuropharmacological and molecular genetic techniques to study the neurobiological basis of abstinence-induced deficits in response inhibition in ADHD and non-ADHD smokers. Twenty smokers with ADHD and 20 smokers without ADHD will undergo imaging during a Go/No-Go task under the following conditions: 1) smoking as usual, 2) 24 hr smoking abstinence, and 3) 24 hr smoking abstinence + methylphenidate (MPH). We hypothesize that compared to smoking as usual, 24 hr smoking abstinence will result in decrements in response inhibition and disruption of task-related brain activation. These effects will be greater in ADHD as compared to non-ADHD smokers. We further hypothesize that MPH administration during abstinence will restore performance and brain indices of response inhibition and that the magnitude of the effect of MPH will be greater among smokers with ADHD. In addition to the above aims, we will preliminarily evaluate the moderating effects of the dopamine receptor D4 7-repeat allele on task-related brain activation following smoking abstinence and MPH administration.
During the study, 101 subjects signed consents and 38 subjects completed the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHD and non-ADHD Smokers | – | –Those that are defined as regular smokers (10 cigarettes/day or Carbon Monoxide reading of 10 ppm). The group will then be split into those diagnosed with ADHD/ADD and controls for comparison. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 120 voluntary participants to yield 40 Adult Regular Smokers, including 20 diagnosed with ADHD and 20 comparison controls.
Key inclusion criteria (5 listed)
- generally healthy, between the ages of 18-50yrs,
- smoking at least 10 cigarettes/day of a brand delivering ≥0.5 mg nicotine according to the standard Federal Trade Commission (FTC) method,
- an expired Carbon Monoxide concentration of at least 10ppm (to confirm inhalation) or a positive urine cotinine test (Nicalert ™) of 3 or greater,
- no interest in quitting smoking as measured by self-report,
- right-handed as measured by a three item scale used in our laboratory.
Key exclusion criteria (9 listed)
- unable to attend all required experimental sessions,
- have significant health problems (e.g., chronic hypertension, emphysema, seizure disorders, history of significant heart problems),
- use of psychoactive medications with the exception of ADHD pharmacotherapies among ADHD diagnosed participants (see washout procedures below)
- use of smokeless tobacco
- current or past year alcohol or drug abuse,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the effects of smoking abstinence on response inhibition brain function in smokers with and without ADHD.
Time frame: July 2009 through December 2013
Smokers will undergo three functional Magnetic Resonance Image scanning sessions while performing a task that measures response inhibition (Go/Go/No-Go task) Scanning will take place in the following conditions: smoking as usual + placebo pill, 24 hr smoking abstinence + placebo pill and 24 hr abstinence + methylphenidate (MPH). Methylphenidate is a dopamine reuptake inhibitor and its administration will allow us to evaluate the role of dopamine neurotransmission on response inhibition in the context of smoking abstinence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
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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.
Francis J McClernon, Ph.D. principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and ADHD, 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 5 inclusion and 9 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 8 Nov 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the effects of smoking abstinence on response inhibition brain function in smokers with and without ADHD. (time frame: July 2009 through December 2013). 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 8 Nov 2018.