Nicotine DependencePhase 2NCT00439413
Selegiline for Smoking Cessation - 1
A Phase 2 study testing Selegiline Transdermal Patch and Smoking Cessation Counseling in people with Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 4 sites in United States.
Trial summary
The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Selegiline Transdermal Patch and Smoking Cessation Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2007to Jan 2009
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be at least 18 years of age
- Be in good general health
- Must meet Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for nicotine dependence
- Be currently smoking > 15 cigarettes/day, and have smoked cigarettes for the past 5 years
- Subjects must be motivated to quite smoking
- If female and of child bearing potential, agrees to use birth control and subject
- Subject must be able to understand and provide written informed consent.
Who cannot join
- Criteria:
- Please contact site for more information
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Tri-State Tobacco and Alcohol Research Center
Cincinnati, Ohio, 45237
Department of Public & Community Health
College Park, Maryland, 20745
Center For Tobacco Research and Intervention
Milwaukee, Wisconsin, 53233
Robert Wood Johnson Med School-Tobacco Dep Program
New Brunswick, New Jersey, 08901
About this study
Official title: Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.
The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.
- Conditions
- Nicotine Dependence
- Being tested
- Selegiline Transdermal Patch, Placebo, Smoking Cessation Counseling
- 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.
Selegiline Transdermal PatchDrug
Also called STS Patch
Selegiline cm(2) via transdermal system
PlaceboDrug
Also called Placebo Patch
Matching placebo via transdermal system
Smoking Cessation CounselingBehavioural
Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| Selegiline Transdermal Patch | Active comparator | Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase.
During treatment, subjects received Selegiline Transdermal System, 6mg -20cm(2) patch, one time per day for 9 weeks
Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks Receives: Drug: Selegiline Transdermal Patch; Behavioral: Smoking Cessation Counseling |
| Placebo | Placebo comparator | Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase.
During treatment, subjects received matched placebo 20cm(2) patch transdermal patch one time per day for 9 weeks
Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks Receives: Drug: Placebo; Behavioral: Smoking Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit Rate
The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9).
Measured: Study weeks 6 through 9
Secondary outcomes (1)
Abstinence
The proportion is determined by dividing the number who achieved abstinence at the end of treatment as defined for the primary outcome measure and are still abstinent by self report and separately by self report with confirmation by exhaled CO by the total number randomized to the treatment group.
Measured: week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2008
- Study completionJan 2009
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- VA Office of Research and Development
- Responsible party
- Sponsor
- Investigators
- Elbert D Glover, Ph.D., Principal investigator, VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439413
- Sponsor's protocol ID
- NIDA-CSP-1022-1
- Status last verified
- Dec 2016
- First submitted
- 22 Feb 2007
- Last updated
- 2 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kahn R, Gorgon L, Jones K, McSherry F, Glover ED, Anthenelli RM, Jackson T, Williams J, Murtaugh C, Montoya I, Yu E, Elkashef A. Selegiline transdermal system (STS) as an aid for smoking cessation. Nicotine Tob Res. 2012 Mar;14(3):377-82. doi: 10.1093/ntr/ntr143. Epub 2011 Aug 16.
PubMed 21846661Hajizadeh 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 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.
- ClinicalTrials.gov ID
- NCT00439413
- Acronym / sponsor ID
- NIDA-CSP-1022-1
- Conditions
- Nicotine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- VA Office of Research and Development
- Study start
- Jun 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 23 Feb 2007 (estimated)
- Results
- Posted 13 Oct 2016
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 designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selegiline Transdermal Patch | Active comparator | Drug: Selegiline Transdermal Patch, Behavioral: Smoking Cessation CounselingSubjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase. During treatment, subjects received Selegiline Transdermal System, 6mg -20cm(2) patch, one time per day for 9 weeks Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: Smoking Cessation CounselingSubjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase. During treatment, subjects received matched placebo 20cm(2) patch transdermal patch one time per day for 9 weeks Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must be at least 18 years of age
- Be in good general health
- Must meet Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for nicotine dependence
- Be currently smoking > 15 cigarettes/day, and have smoked cigarettes for the past 5 years
- Subjects must be motivated to quite smoking
Key exclusion criteria (2 listed)
- Please contact site for more information
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 |
|---|---|---|
| Selegiline Transdermal PatchAlso: STS PatchSelegiline cm(2) via transdermal system | Drug | Selegiline Transdermal Patch |
| PlaceboAlso: Placebo PatchMatching placebo via transdermal system | Drug | Placebo |
| Smoking Cessation CounselingSubjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks | Behavioural | Placebo, Selegiline Transdermal Patch |
Primary outcome
Quit Rate
Time frame: Study weeks 6 through 9
The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9).
1 secondary outcome
Abstinence
Time frame: week 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21846661Kahn R, Gorgon L, Jones K, McSherry F, Glover ED, Anthenelli RM, Jackson T, Williams J, Murtaugh C, Montoya I, Yu E, Elkashef A. Selegiline transdermal system (STS) as an aid for smoking cessation. Nicotine Tob Res. 2012 Mar;14(3):377-82. doi: 10.1093/ntr/ntr143. Epub 2011 Aug 16.
- 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.
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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.
Elbert D Glover, Ph.D. principal investigator
VA Medical Center
4 sites 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 Transdermal Patch and Smoking Cessation Counseling in people with Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 4 sites 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 7 inclusion and 2 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 13 Oct 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?
Quit Rate (time frame: Study weeks 6 through 9). 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 NCT00439413, 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 2 Feb 2017.