SmokingPhase 1NCT00018187
Combinations of Pharmacologic Smoking Cessation Treatments
A Phase 1 study testing Bupropion, Mecamylamine and Nicotine Patch in people with Smoking, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of a combination of the drugs bupropion and mecamylamine along with a nicotine patch as a therapy for smoking cessation. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Smoking
- What is being tested?
- Bupropion, Mecamylamine and Nicotine Patch
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 1998to Jun 2001
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Subjects must be a smoker between 20 and 40 years old, have smoked at least 20 cigarettes per day for at least 2 years, wish to stop smoking and be in good general health
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
About this study
The purpose of this study is to test the effectiveness of a combination of the drugs bupropion and mecamylamine along with a nicotine patch as a therapy for smoking cessation.
- Conditions
- Smoking
- Being tested
- Bupropion, Mecamylamine, Nicotine Patch
- Keywords
- smoking cessation, bupropion, mecamylamine, nicotine
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
MecamylamineDrug
Nicotine PatchDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2001 (estimated)
- Study startNov 1998
- Study completionJun 2001
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.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Neil Hartman, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018187
- Sponsor's protocol ID
- ADRD-011-98S
- Status last verified
- May 2007
- First submitted
- 3 Jul 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combinations of Pharmacologic Smoking Cessation Treatments
- ClinicalTrials.gov ID
- NCT00018187
- Acronym / sponsor ID
- ADRD-011-98S
- Conditions
- Smoking
- Keywords
- smoking cessation, bupropion, mecamylamine, nicotine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 1998
- Study completion
- Jun 2001
- First posted
- 5 Jul 2001 (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 test the effectiveness of a combination of the drugs bupropion and mecamylamine along with a nicotine patch as a therapy for smoking cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 | Drug | – |
| Mecamylamine | Drug | – |
| Nicotine Patch | Drug | – |
Primary outcome
Not reported in the source record.
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 21 Jan 2009.
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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.
Neil Hartman, M.D.
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 Bupropion, Mecamylamine and Nicotine Patch in people with Smoking, 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?
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 21 Jan 2009. 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.
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 21 Jan 2009.