Tobacco Use DisorderPhase 2NCT01330030
Selegiline Patch for Treatment of Nicotine Dependence
A Phase 2 study testing Selegiline in people with Tobacco Use Disorder, run by Stanford University at 1 site in United States.
Trial summary
Relapse to smoking is a common problem affecting smokers who seek treatment. The purpose of this study is examine whether selegiline, given in the form of a skin patch, is effective in stopping smoking. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Selegiline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jul 2011
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smokes greater than 20 cigarettes per day
Who cannot join
- History of Parkinson's disease, high blood pressure, or severe liver or kidney disease
- Current substance abuse
- Mental illness
- Skin conditions that could interfere with patch use
- Using antidepressant medications (e.g., levodopa/carbidopa, methyldopa, or any MAO inhibitor)
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Relapse to smoking is a common problem affecting smokers who seek treatment. The purpose of this study is examine whether selegiline, given in the form of a skin patch, is effective in stopping smoking.
Read the detailed description
Most smokers relapse following smoking cessation treatment. More effective smoking cessation therapies are needed to prevent the high rates of relapse. Selegiline is a selective inhibitor of monoamine oxidase B (MAO B) and has been used clinically in combination with levodopa to treat Parkinson's disease. Selegiline permits the stabilization of dopamine (DA) levels in the brain by preventing the rapid degradation of DA by means of MAO B and is used as an adjunct to levodopa therapy causing a dose-sparing effect and enhancing dopaminergic transmission. Selegiline's effect on MAO B and the resulting effect on brain DA has interesting implications for the treatment of nicotine dependence because brain DA systems may play a key role in the mediation of reward learning behavior. Previous research suggests that the brains of living smokers show a 40% decrease in the level of MAO B relative to nonsmokers or former smokers. The purpose of this study is examine whether selegiline, administered in the form of a skin patch, is effective for smoking cessation.
Participants will be randomly assigned to one of two treatments: 1) transdermal selegiline patch (STS) or 2) placebo. Treatment with STS or placebo will be given for a period of 8 weeks. Participants will be stratified by gender to evaluate the role that gender plays in moderating smoking cessation treatment. Study visits will take place once each week for 30 to 45 minutes, and will include adverse events monitoring, biochemical verification of smoking status, and a physical exam. Follow-up visits will occur at Weeks 24 and 52 to determine response to treatment.
- Conditions
- Tobacco Use Disorder
- Being tested
- Selegiline, matching placebo
- 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.
SelegilineDrug
Also called EMSAM
6mg/24 hrs for 8 weeks
matching placeboOther
Also called Placebo
placebo/24hrs for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Drug Selegiline | Experimental | 6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks Receives: Drug: Selegiline |
| Matching placebo | Placebo comparator | matching placebo worn 24 hours for 8 weeks Receives: Other: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expired-air Carbon Monoxide Confirmed Smoking Abstinence
expired-air carbon monoxide confirmed smoking abstinence at 52 weeks
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startJul 2005
- Primary completionAug 2008
- Study completionJul 2011
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Joel D Killen, Stanford University
- Investigators
- Joel D Killen, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330030
- Sponsor's protocol ID
- SU-07232007-459
- Other IDs
- R01DA017457
- Status last verified
- May 2016
- First submitted
- 8 Nov 2010
- Last updated
- 10 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Killen JD, Fortmann SP, Murphy GM Jr, Hayward C, Fong D, Lowenthal K, Bryson SW, Killen DT, Schatzberg AF. Failure to improve cigarette smoking abstinence with transdermal selegiline + cognitive behavior therapy. Addiction. 2010 Sep;105(9):1660-8. doi: 10.1111/j.1360-0443.2010.03020.x.
PubMed 20707784Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PubMed 37230961
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selegiline Patch for Treatment of Nicotine Dependence
- ClinicalTrials.gov ID
- NCT01330030
- Acronym / sponsor ID
- SU-07232007-459
- Conditions
- Tobacco Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Posted 4 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Relapse to smoking is a common problem affecting smokers who seek treatment. The purpose of this study is examine whether selegiline, given in the form of a skin patch, is effective in stopping smoking.
Detailed description
Most smokers relapse following smoking cessation treatment. More effective smoking cessation therapies are needed to prevent the high rates of relapse. Selegiline is a selective inhibitor of monoamine oxidase B (MAO B) and has been used clinically in combination with levodopa to treat Parkinson's disease. Selegiline permits the stabilization of dopamine (DA) levels in the brain by preventing the rapid degradation of DA by means of MAO B and is used as an adjunct to levodopa therapy causing a dose-sparing effect and enhancing dopaminergic transmission. Selegiline's effect on MAO B and the resulting effect on brain DA has interesting implications for the treatment of nicotine dependence because brain DA systems may play a key role in the mediation of reward learning behavior. Previous research suggests that the brains of living smokers show a 40% decrease in the level of MAO B relative to nonsmokers or former smokers. The purpose of this study is examine whether selegiline, administered in the form of a skin patch, is effective for smoking cessation.
Participants will be randomly assigned to one of two treatments: 1) transdermal selegiline patch (STS) or 2) placebo. Treatment with STS or placebo will be given for a period of 8 weeks. Participants will be stratified by gender to evaluate the role that gender plays in moderating smoking cessation treatment. Study visits will take place once each week for 30 to 45 minutes, and will include adverse events monitoring, biochemical verification of smoking status, and a physical exam. Follow-up visits will occur at Weeks 24 and 52 to determine response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Selegiline | Experimental | Drug: Selegiline6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks |
| Matching placebo | Placebo comparator | Other: matching placebomatching placebo worn 24 hours for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Smokes greater than 20 cigarettes per day
Key exclusion criteria (6 listed)
- History of Parkinson's disease, high blood pressure, or severe liver or kidney disease
- Current substance abuse
- Mental illness
- Skin conditions that could interfere with patch use
- Using antidepressant medications (e.g., levodopa/carbidopa, methyldopa, or any MAO inhibitor)
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 |
|---|---|---|
| SelegilineAlso: EMSAM6mg/24 hrs for 8 weeks | Drug | Drug Selegiline |
| matching placeboAlso: Placeboplacebo/24hrs for 8 weeks | Other | Matching placebo |
Primary outcome
Expired-air Carbon Monoxide Confirmed Smoking Abstinence
Time frame: 52 weeks
expired-air carbon monoxide confirmed smoking abstinence at 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20707784Killen JD, Fortmann SP, Murphy GM Jr, Hayward C, Fong D, Lowenthal K, Bryson SW, Killen DT, Schatzberg AF. Failure to improve cigarette smoking abstinence with transdermal selegiline + cognitive behavior therapy. Addiction. 2010 Sep;105(9):1660-8. doi: 10.1111/j.1360-0443.2010.03020.x.
- Derived from this study: PubMed 37230961Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use Disorder
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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.
Joel D Killen principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selegiline in people with Tobacco Use Disorder, run by Stanford 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 1 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 10 Aug 2016. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2016). 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?
Expired-air Carbon Monoxide Confirmed Smoking Abstinence (time frame: 52 weeks). 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 NCT01330030, which also lists 2 linked publications.
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 10 Aug 2016.