Nicotine DependenceNCT02348385
Imaging Extrastriatal Dopamine Release in Tobacco Smokers and Nonsmokers
An observational study of Nicotine Dependence, run by Yale University at 1 site in United States.
Trial summary
The goal is to examine sex differences in amphetamine-induced dopamine release in tobacco smokers and nonsmokers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Amphetamine
- Type of treatment
- Pill or oral medicine
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2017
- Phase
- Observational
- 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
Study population: Healthy Smokers and non smokers
General inclusion criteria:
- men and women, aged 18-55 years
- who are able to read and write
- who are able to give voluntary written informed consent
- have no current uncontrolled medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology
- have no history of a neurological or psychiatric disorder, e.g., no DSM-IV Axis 1 diagnosis in 2 preceding years)
- drink less than 21 drinks/week for women and less than 35 drinks per week for men
- have not used marijuana in the past 30 days and have not met criteria for dependence in the past 2 years
- do not suffer from claustrophobia or any MRI contradictions
- to participate in imaging studies including 2 PET scans and 1 MRI scan
- nonsmokers (smoked < 100 cigarettes in lifetime with urinary cotinine levels 0-30 ng/mL both at intake evaluation and on scan day)
- smokers (smoked at least 10 cigarettes/day for at least one year with an Fagerstrom score (FTND)>3, urine cotinine >150 ng/mL and carbon monoxide (CO) >12 ppm at intake)
General exclusion criteria:
- psychosis
- presence of acute or unstable medical or neurological illness. Subjects will be excluded from the study if they present with any history of serious medical or neurological illness or if they show signs of a major medical or neurological illness on examination or lab testing including history of seizures, head injury, brain tumor, heart, liver or kidney disease, eating disorder, diabetes.
- regular use of any psychotropic drugs including anxiolytics and antidepressants and other over-the-counter medications and herbal products within the last six months
- pregnancy/Breast feeding (as documented by pregnancy testing at screening or at days of the imaging studies),
- suicidal ideation or behavior
- pacemaker or other ferromagnetic material in body.
- use of medications which affect dopamine transmission within 2 weeks of the PET study
- Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits for normal volunteers.
- Blood donation within 8 weeks of the start of the study.
- history of a bleeding disorder or are taking medication to thin their blood
Trial locations and contacts
1 site in 1 country.
About this study
The goal is to examine sex differences in amphetamine-induced dopamine release in tobacco smokers and nonsmokers.
Read the detailed description
Aim 1:
To determine sex differences in amphetamine-induced dopamine (DA) release in healthy tobacco smokers and nonsmokers.
FLB-457 has been used in several PET centers and has recently been approved for use at the Yale University PET Center. We would like to determine whether there are sex differences in amphetamine induced DA release in healthy tobacco smokers and nonsmokers. Specifically, 40 healthy tobacco smokers and 40 healthy nonsmokers will have an magnetic resonance imaging (MRI) scan followed on another day by two FLB scans (ideally, the two PET scans will be carried out in the same day). Starting at 3 hours before the second PET scan, amphetamine (0.4mg/kg, PO) will be administered.
Aim 2:
To determine sex differences in amphetamine-induced dopamine release in tobacco smokers from Aim 1 after treatment with guanfacine. Guanfacine will be given under a different protocol. We plan to determine whether guanfacine treatment differentially inhibits amphetamine-induced DA release in men and smokers from Aim 1. After their first scan, the same 40 healthy tobacco smokers from Aim 1 will take guanfacine for 3 weeks under and then will have another set of FLB scans (ideally, the two PET scans will be carried out in the same day). Starting at 3 hours before the second PET scan, amphetamine (0.4mg/kg, PO) will be administered, as before. The sets of scans will be separated by at least 21 days, but due to scheduling and technical difficulties the second set may be scheduled up to 6 weeks after the first set.
- Conditions
- Nicotine Dependence
- Being tested
- Amphetamine
- Keywords
- amphetamine, cigarette smokers
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmphetamineDrug
Also called dextroamphetamine
Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Tobacco Smokers | There is only one arm to the study. All subjects will receive amphetamine Receives: Drug: Amphetamine | |
| Healthy Nonsmokers | There is only one arm to the study. All subjects will receive amphetamine Receives: Drug: Amphetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Binding Potential of Dopamine Release During PET Scan Post Amphetamine Administration
Percent change in binding potential of dopamine release during PET scan post amphetamine administration.Binding potential (BP) is the PET neuroimaging outcome measure that is computed as a proxy for availability of dopamine D2/3 receptors in a given region-of-interest.
Measured: After 2 PET Scans (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startDec 2012
- Primary completionDec 2017
- Study completionDec 2017
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 DependenceStudies of the same condition, open and under way.
- More trials run by Yale 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kelly Cosgrove, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348385
- Sponsor's protocol ID
- 1106008678
- Other IDs
- 1K02DA031750-01A1
- Status last verified
- Feb 2023
- First submitted
- 21 Jan 2015
- Last updated
- 2 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Extrastriatal Dopamine Release in Tobacco Smokers and Nonsmokers
- ClinicalTrials.gov ID
- NCT02348385
- Acronym / sponsor ID
- 1106008678
- Conditions
- Nicotine Dependence
- Keywords
- amphetamine, cigarette smokers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Posted 18 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to examine sex differences in amphetamine-induced dopamine release in tobacco smokers and nonsmokers.
Detailed description
Aim 1:
To determine sex differences in amphetamine-induced dopamine (DA) release in healthy tobacco smokers and nonsmokers.
FLB-457 has been used in several PET centers and has recently been approved for use at the Yale University PET Center. We would like to determine whether there are sex differences in amphetamine induced DA release in healthy tobacco smokers and nonsmokers. Specifically, 40 healthy tobacco smokers and 40 healthy nonsmokers will have an magnetic resonance imaging (MRI) scan followed on another day by two FLB scans (ideally, the two PET scans will be carried out in the same day). Starting at 3 hours before the second PET scan, amphetamine (0.4mg/kg, PO) will be administered.
Aim 2:
To determine sex differences in amphetamine-induced dopamine release in tobacco smokers from Aim 1 after treatment with guanfacine. Guanfacine will be given under a different protocol. We plan to determine whether guanfacine treatment differentially inhibits amphetamine-induced DA release in men and smokers from Aim 1. After their first scan, the same 40 healthy tobacco smokers from Aim 1 will take guanfacine for 3 weeks under and then will have another set of FLB scans (ideally, the two PET scans will be carried out in the same day). Starting at 3 hours before the second PET scan, amphetamine (0.4mg/kg, PO) will be administered, as before. The sets of scans will be separated by at least 21 days, but due to scheduling and technical difficulties the second set may be scheduled up to 6 weeks after the first set.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Tobacco Smokers | – | Drug: AmphetamineThere is only one arm to the study. All subjects will receive amphetamine |
| Healthy Nonsmokers | – | Drug: AmphetamineThere is only one arm to the study. All subjects will receive amphetamine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Smokers and non smokers
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 |
|---|---|---|
| AmphetamineAlso: dextroamphetamineSubjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered. | Drug | Healthy Nonsmokers, Healthy Tobacco Smokers |
Primary outcome
Percent Change in Binding Potential of Dopamine Release During PET Scan Post Amphetamine Administration
Time frame: After 2 PET Scans (1 day)
Percent change in binding potential of dopamine release during PET scan post amphetamine administration.Binding potential (BP) is the PET neuroimaging outcome measure that is computed as a proxy for availability of dopamine D2/3 receptors in a given region-of-interest.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kelly Cosgrove, PhD principal investigator
Yale University
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 Nicotine Dependence, run by Yale 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?
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 2 Mar 2023. 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?
Yes. Results are posted in the registry (first posted 18 Mar 2020). 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?
Percent Change in Binding Potential of Dopamine Release During PET Scan Post Amphetamine Administration (time frame: After 2 PET Scans (1 day)). 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 2 Mar 2023.