Tobacco Use CessationPhase 2NCT00129311
Usefulness of Selegiline as an Aid to Quit Smoking - 1
A Phase 2 study testing Selegiline in people with Tobacco Use Cessation, run by Yale University at 1 site in United States.
Trial summary
Despite the widespread use of nicotine replacement therapies for the treatment of nicotine dependence, many smokers are still unable to quit smoking. The purpose of this study is to determine the safety and effectiveness of selegiline as an aid to help smokers quit smoking. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Selegiline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Dec 2012
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets DSM-IV criteria for nicotine dependence with a Fagerstrom Test of Nicotine Dependence (FTND) score greater than 5
- Smokes at least 15 cigarettes daily (averaged over 1 week, within the month prior to enrollment)
- Motivated to quit smoking within 30 days at time of initial evaluation
- At least one unsuccessful attempt to quit smoking in the past year
- An expired breath CO level greater than 10 ppm and baseline plasma cotinine level greater than 150 ng/ml at initial evaluation
- Body weight of at least 100 lb
- Avoidance of nicotine replacement product use one month prior to enrollment
- Speaks English
Who cannot join
- Currently taking over-the-counter or prescription sympathomimetic agents (e.g., pseudoephedrine, methylphenidate), antidepressant agents (e.g., tricyclic antidepressants, serotonin reuptake inhibitors, bupropion, other monoamine oxidase inhibitors), or meperidine (Demerol)
- Serious medical disorders such as unstable angina or liver failure
- Abnormalities in baseline bloodwork (e.g., threefold elevation of liver function tests, electrolyte abnormalities)
- Physiologically dependent on and/or abusing alcohol or other drugs of abuse (e.g., cocaine, opiates, benzodiazepines, etc.) during the 6 months prior to enrollment (based on a clinical evaluation, which includes a self-report, and is confirmed by a positive urine toxicology screen)
- Meets DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder, or post-traumatic stress disorder
- Current or past history of bipolar disorder or schizophrenia
Show all 11Show fewer
- Past history of major depression associated with historical evidence of suicidal or homicidal behavior, or psychotic symptoms
- Currently residing with another study participant
- Presence of suicidal or homicidal ideation
- Significant impairment of social or occupational functioning, either at time of initial evaluation or during the trial
- Known hypersensitivity to selegiline hydrochloride
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of Selegiline for Smoking Cessation
Despite the widespread use of nicotine replacement therapies for the treatment of nicotine dependence, many smokers are still unable to quit smoking. The purpose of this study is to determine the safety and effectiveness of selegiline as an aid to help smokers quit smoking.
Read the detailed description
Despite the availability of nicotine replacement therapies and sustained-relapse bupropion for the treatment of nicotine dependence, there is still a significant proportion of cigarette smokers who are unable to quit smoking. Therefore, new and effective pharmacotherapies for smoking cessation are needed. The primary aim of this study is to determine the safety and efficacy of selegiline as an aid to smoking cessation.
In this study, 200 nicotine-dependent cigarette smokers will participate in an 8-week, double-blind, placebo-controlled trial and then will be followed over 4 years. Participants will be randomly assigned to receive either selegiline or placebo. Selegiline doses of 5 mg will be taken once a day during the first week. This will be increased to 5 mg twice daily for the remaining 7 weeks. The target smoking "quit date" will be Day 15. All smokers will receive brief weekly manualized smoking cessation counseling from the Mayo Clinic's "Smoke Free and Livin' It" program. The primary smoking cessation outcome measure will be 7-day point prevalence smoking abstinence at the 6-month follow-up. Secondary cessation outcome measures will include continuous smoking abstinence during the last four weeks of the trial (Days 29-56) and 7-day point prevalence abstinence at the end of the 8-week trial (Days 49-56).
- Conditions
- Tobacco Use Cessation
- Being tested
- Selegiline, Placebo
- Keywords
- Tobacco
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelegilineDrug
Also called L-deprenyl; Eldepryl®
5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Selegiline Receives: Drug: Selegiline |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
7 Day Point Prevalence of Cigarette Abstinence
Measured: 6-month follow up
7 Day Point Prevalence of Cigarette Abstinence
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2005 (estimated)
- Study startJul 2004
- Primary completionDec 2012
- Study completionDec 2012
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 CessationStudies of the same condition, open and under way.
- More trials run by Yale 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Tony P George, M.D., Principal investigator, Yale UniversityMarc N Potenza, M.D., Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129311
- Sponsor's protocol ID
- NIDA-15757-1
- Other IDs
- R01DA015757, R01-15757-1, DPMC
- Status last verified
- Jul 2014
- First submitted
- 9 Aug 2005
- Last updated
- 31 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hajizadeh 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 37230961Weinberger AH, Reutenauer EL, Jatlow PI, O'Malley SS, Potenza MN, George TP. A double-blind, placebo-controlled, randomized clinical trial of oral selegiline hydrochloride for smoking cessation in nicotine-dependent cigarette smokers. Drug Alcohol Depend. 2010 Mar 1;107(2-3):188-95. doi: 10.1016/j.drugalcdep.2009.10.009. Epub 2009 Nov 24.
PubMed 19939587
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Selegiline for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00129311
- Acronym / sponsor ID
- NIDA-15757-1
- Conditions
- Tobacco Use Cessation
- Keywords
- Tobacco
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2004
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Aug 2005 (estimated)
- Results
- Posted 16 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the widespread use of nicotine replacement therapies for the treatment of nicotine dependence, many smokers are still unable to quit smoking. The purpose of this study is to determine the safety and effectiveness of selegiline as an aid to help smokers quit smoking.
Detailed description
Despite the availability of nicotine replacement therapies and sustained-relapse bupropion for the treatment of nicotine dependence, there is still a significant proportion of cigarette smokers who are unable to quit smoking. Therefore, new and effective pharmacotherapies for smoking cessation are needed. The primary aim of this study is to determine the safety and efficacy of selegiline as an aid to smoking cessation.
In this study, 200 nicotine-dependent cigarette smokers will participate in an 8-week, double-blind, placebo-controlled trial and then will be followed over 4 years. Participants will be randomly assigned to receive either selegiline or placebo. Selegiline doses of 5 mg will be taken once a day during the first week. This will be increased to 5 mg twice daily for the remaining 7 weeks. The target smoking "quit date" will be Day 15. All smokers will receive brief weekly manualized smoking cessation counseling from the Mayo Clinic's "Smoke Free and Livin' It" program. The primary smoking cessation outcome measure will be 7-day point prevalence smoking abstinence at the 6-month follow-up. Secondary cessation outcome measures will include continuous smoking abstinence during the last four weeks of the trial (Days 29-56) and 7-day point prevalence abstinence at the end of the 8-week trial (Days 49-56).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SelegilineSelegiline |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meets DSM-IV criteria for nicotine dependence with a Fagerstrom Test of Nicotine Dependence (FTND) score greater than 5
- Smokes at least 15 cigarettes daily (averaged over 1 week, within the month prior to enrollment)
- Motivated to quit smoking within 30 days at time of initial evaluation
- At least one unsuccessful attempt to quit smoking in the past year
- An expired breath CO level greater than 10 ppm and baseline plasma cotinine level greater than 150 ng/ml at initial evaluation
Key exclusion criteria (11 listed)
- Currently taking over-the-counter or prescription sympathomimetic agents (e.g., pseudoephedrine, methylphenidate), antidepressant agents (e.g., tricyclic antidepressants, serotonin reuptake inhibitors, bupropion, other monoamine oxidase inhibitors), or meperidine (Demerol)
- Serious medical disorders such as unstable angina or liver failure
- Abnormalities in baseline bloodwork (e.g., threefold elevation of liver function tests, electrolyte abnormalities)
- Physiologically dependent on and/or abusing alcohol or other drugs of abuse (e.g., cocaine, opiates, benzodiazepines, etc.) during the 6 months prior to enrollment (based on a clinical evaluation, which includes a self-report, and is confirmed by a positive urine toxicology screen)
- Meets DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder, or post-traumatic stress disorder
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: L-deprenyl; Eldepryl®5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks. | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
7 Day Point Prevalence of Cigarette Abstinence
Time frame: 6-month follow up
7 Day Point Prevalence of Cigarette Abstinence
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Derived from this study: PubMed 19939587Weinberger AH, Reutenauer EL, Jatlow PI, O'Malley SS, Potenza MN, George TP. A double-blind, placebo-controlled, randomized clinical trial of oral selegiline hydrochloride for smoking cessation in nicotine-dependent cigarette smokers. Drug Alcohol Depend. 2010 Mar 1;107(2-3):188-95. doi: 10.1016/j.drugalcdep.2009.10.009. Epub 2009 Nov 24.
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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.
Tony P George, M.D. principal investigator
Yale University
Marc N Potenza, M.D., Ph.D. principal investigator
Yale 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 Cessation, run by Yale 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 8 inclusion and 11 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 31 Mar 2015. 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 16 Jul 2014). 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?
7 Day Point Prevalence of Cigarette Abstinence (time frame: 6-month follow up). The study lists 2 primary outcomes in all. 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 NCT00129311, 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 31 Mar 2015.