Nicotine DependencePhase 1NCT00108173
Brain Reaction to Treatment of Nicotine Dependence
A Phase 1 study testing Zyban in people with Nicotine Dependence, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of the study was to determine how the treatments for cigarette craving work. Hypothesis: During exposure to cigarette-related cues, heavy smokers will have greater reductions in regional brain activation from before to after both forms of active treatments than from before to after placebo. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Zyban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Jun 2011
- Phase
- Phase 1
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Heavy smoker, more than one pack per day
- Free of medical conditions or medications that affect brain activity
- Not pregnant
Who cannot join
- Drug or alcohol dependence Mental Illness Pregnancy Medications that affect brain function Unstable medical conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073
About this study
Official title: Neural Substrates of Treatment for Nicotine Dependence
The purpose of the study was to determine how the treatments for cigarette craving work.
Hypothesis: During exposure to cigarette-related cues, heavy smokers will have greater reductions in regional brain activation from before to after both forms of active treatments than from before to after placebo.
Read the detailed description
PET and fMRI scanning were used to examine brain activity and activation in cigarette smokers in response to cigarette-related cues.
- Conditions
- Nicotine Dependence
- Being tested
- Zyban
- Keywords
- Position Emission Tomography (PET), Nicotine dependence, functional magnetic resonance imaging, cigarette cues
- 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.
ZybanDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Drug: Zyban |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-FA PET scan results
Brain activity and activation in response to cigarette-related cues
Measured: Within the first few weeks of study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2005 (estimated)
- Study startOct 2002
- Primary completionApr 2007
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Arthur L. Brody, MD, Principal investigator, VA Greater Los Angeles Healthcare System, West LA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108173
- Sponsor's protocol ID
- ADRD-018-02S
- Status last verified
- Apr 2013
- First submitted
- 14 Apr 2005
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Substrates of Treatment for Nicotine Dependence
- ClinicalTrials.gov ID
- NCT00108173
- Acronym / sponsor ID
- ADRD-018-02S
- Conditions
- Nicotine Dependence
- Keywords
- Position Emission Tomography (PET), Nicotine dependence, functional magnetic resonance imaging, cigarette cues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Apr 2005 (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 the study was to determine how the treatments for cigarette craving work.
Hypothesis: During exposure to cigarette-related cues, heavy smokers will have greater reductions in regional brain activation from before to after both forms of active treatments than from before to after placebo.
Detailed description
PET and fMRI scanning were used to examine brain activity and activation in cigarette smokers in response to cigarette-related cues.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Drug: Zyban |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Heavy smoker, more than one pack per day
- Free of medical conditions or medications that affect brain activity
- Not pregnant
Key exclusion criteria (1 listed)
- Drug or alcohol dependence Mental Illness Pregnancy Medications that affect brain function Unstable medical conditions
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 |
|---|---|---|
| Zyban | Drug | Arm 1 |
Primary outcome
2-FA PET scan results
Time frame: Within the first few weeks of study initiation
Brain activity and activation in response to cigarette-related cues
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 9 Apr 2013.
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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.
Arthur L. Brody, MD principal investigator
VA Greater Los Angeles Healthcare System, West LA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zyban in people with Nicotine Dependence, run by US Department of Veterans Affairs 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 3 inclusion and 1 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 9 Apr 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
2-FA PET scan results (time frame: Within the first few weeks of study initiation). 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 9 Apr 2013.