Nicotine DependenceNCT00267813
The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers
A study testing Bupropion (Zyban) in people with Nicotine Dependence, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban). Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Bupropion (Zyban)
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2004to Oct 2007
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cigarette smokers (over 1 pack a day)
- Age 20-65, male-females
Who cannot join
- Dependence on other substances
- Psychiatric diagnosis
- Neurological disorder
- Obesity
- Young persons
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers.
Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban). We compare cue-induced reactivity to smoking videos in smokers who were successfully treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic activity in response to smoking and neutral cues in Positron Emission Tomography using FDG.
Read the detailed description
Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban)for 2 months. We compare cue-induced reactivity to smoking videos in smokers who were successfully treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic activity after exposure to videotapes showing smoking and neutral scenes in Positron Emission Tomography using FDG. There were 2 scanning sessions, one with a smoking videotape and one with a neutral video separated by a week. So far we have compared the brain's metabolic activity in 6 abstinent smokers and 6 still smokers.
- Conditions
- Nicotine Dependence
- Being tested
- Bupropion (Zyban)
- Keywords
- craving, nicotine, imaging, FDG, PET, smoking, Bupropion
- 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.
Bupropion (Zyban)Drug
1 tablet a day increasing to 2 tablets a day after a week
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain metabolic activity (FDG) in response to craving and neutral cues.
Measured: 30-40 minutes
Secondary outcomes (1)
Subjective ratings of craving
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startJul 2004
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Einat Even-Sapir, M.D, Ph.D, Principal investigator, Tel-Aviv Sourasky Medical CenterAviv M Weinstein, Ph.D, Principal investigator, Tel-Aviv Sourasky Medical CenterHedva Lerman, M.D, Study director, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267813
- Sponsor's protocol ID
- TASMC-O5-EE-065-CTIL
- Status last verified
- May 2008
- First submitted
- 20 Dec 2005
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Weinstein A, Greif J, Yemini Z, Lerman H, Weizman A, Even-Sapir E. Attenuation of cue-induced smoking urges and brain reward activity in smokers treated successfully with bupropion. J Psychopharmacol. 2010 Jun;24(6):829-38. doi: 10.1177/0269881109105456. Epub 2009 Jul 31.
PubMed 19648219
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers.
- ClinicalTrials.gov ID
- NCT00267813
- Acronym / sponsor ID
- TASMC-O5-EE-065-CTIL
- Conditions
- Nicotine Dependence
- Keywords
- craving, nicotine, imaging, FDG, PET, smoking, Bupropion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 21 Dec 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.
Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban). We compare cue-induced reactivity to smoking videos in smokers who were successfully treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic activity in response to smoking and neutral cues in Positron Emission Tomography using FDG.
Detailed description
Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban)for 2 months. We compare cue-induced reactivity to smoking videos in smokers who were successfully treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic activity after exposure to videotapes showing smoking and neutral scenes in Positron Emission Tomography using FDG. There were 2 scanning sessions, one with a smoking videotape and one with a neutral video separated by a week. So far we have compared the brain's metabolic activity in 6 abstinent smokers and 6 still smokers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cigarette smokers (over 1 pack a day)
- Age 20-65, male-females
Key exclusion criteria (6 listed)
- Dependence on other substances
- Psychiatric diagnosis
- Neurological disorder
- Obesity
- Young persons
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 |
|---|---|---|
| Bupropion (Zyban)1 tablet a day increasing to 2 tablets a day after a week | Drug | – |
Primary outcome
Brain metabolic activity (FDG) in response to craving and neutral cues.
Time frame: 30-40 minutes
1 secondary outcome
Subjective ratings of craving
Time frame: 10 minutes
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 7 May 2008.
- Derived from this study: PubMed 19648219Weinstein A, Greif J, Yemini Z, Lerman H, Weizman A, Even-Sapir E. Attenuation of cue-induced smoking urges and brain reward activity in smokers treated successfully with bupropion. J Psychopharmacol. 2010 Jun;24(6):829-38. doi: 10.1177/0269881109105456. Epub 2009 Jul 31.
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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.
Einat Even-Sapir, M.D, Ph.D principal investigator
Tel-Aviv Sourasky Medical Center
Aviv M Weinstein, Ph.D principal investigator
Tel-Aviv Sourasky Medical Center
Hedva Lerman, M.D study director
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupropion (Zyban) in people with Nicotine Dependence, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 2 inclusion and 6 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 7 May 2008. 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 Israel. 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?
Brain metabolic activity (FDG) in response to craving and neutral cues. (time frame: 30-40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00267813, which also lists 1 linked publication.
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 7 May 2008.