Nicotine DependenceNCT00390923
Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence
A study testing Selegiline + nicotine replacement therapy in people with Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
This study will test a new medication strategy designed to help smokers quit. It will combine selegiline, a drug currently approved and available for the treatment of Parkinson's disease, with a nicotine skin patch. Forty nicotine-dependent smokers will enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Selegiline + nicotine replacement therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2007to Apr 2008
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet DSM-IV criteria for nicotine dependence with FTND score > 5.
- Smoke at least 15 cigarettes (3/4 pack) daily (averaged over 1 week, in the past 1 month).
- At the time of initial evaluation, are motivated to quit smoking in the next 30 days.
- Have made at least one unsuccessful attempt to quit smoking in the past year.
- At baseline, have expired breath CO level > 10.
- Are between ages 18-70 years old.
Show all 9Show fewer
- Weigh at least 100 lbs (45.5 kg, selegiline dose < 0.22 mg/kg).
- No previous use of nicotine replacement products in the one month prior to randomization.
- Have the capacity to give informed consent, and are English-speaking.
Who cannot join
- Have present or past diagnoses of schizophrenia, bipolar disorder, PTSD, BPD or major depressive illness.
- Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 6 months prior to randomization into the trial (based on clinical evaluation including self-report, and confirmed by positive urine).
- Demonstrate serious medical conditions (i.e. abnormal liver function [as evidenced by AST, ALT or bilirubin values 2x ULN], unstable cardiovascular disease, significant blood abnormalities).
- Exhibit or have history of clinical hypertension.
- Exhibit active peptic ulcer disease.
- Are pregnant, are trying to become pregnant, or are currently breastfeeding.
Show all 9Show fewer
- Are on current medication regimes that include antidepressants, or sympathomimetic agents, or meperidine and other meperidine-opioids which may have interactions with selegiline.
- Known hypersensitivity to selegiline or NRT.
- Are from the same household as another study participant.
Trial locations and contacts
1 site in 1 country.
About this study
This study will test a new medication strategy designed to help smokers quit. It will combine selegiline, a drug currently approved and available for the treatment of Parkinson's disease, with a nicotine skin patch. Forty nicotine-dependent smokers will enrolled in this study. Twenty will receive placebo (inactive pill) plus nicotine patch, and twenty will receive selegiline plus nicotine patch. Once enrolled in the study, subjects will visit the Nicotine Dependence Clinic at CAMH on a weekly basis for assessment of smoking behavior, a brief health check, collection of breath and urine samples (necessary to drug levels and nicotine levels), and receive brief individual counseling designed to help them stop smoking. The medication phase of this study lasts 9 weeks. A follow-up visit will be conducted six months after trial completion. At that point, health and behavioral measures will be re-assessed.
Read the detailed description
This pilot study utilizes a double-blind, two-armed design to evaluate the efficacy of combining oral selegiline with transdermal nicotine patch for smoking cessation in 40 nicotine-dependent smokers. After successful completion of 3 screening visits (to ensure medical and psychiatric eligibility criteria are met), subjects will be randomized into one of two experimental groups:
- selegiline (10 mg/day) + NRT (21 mg/24 hr)
- matching placebo + NRT (21 mg/24 hr)
Randomization will be performed through the use a random number list to generate 50% selegiline/50% placebo and also 50% male/50% female within each of those treatment groups.
Participants will begin selegiline (or placebo) once a day during Week 1, and dose will be graduated to full study dosage (10 mg/day) by adding an evening intake (a.m. and p.m. dosing) for Weeks 2-8. Day 15 of the trial represents target quit day and the transdermal nicotine patch (21 mg/24hr) will be applied at this time. Patches will be worn in conjunction with study medication for Weeks 3-8, after which the patch will be removed and study medication tapered throughout Week 9.
Subjects will present weekly to the Nicotine Dependence Clinic where they will provide breath, urine and blood samples as required, receive brief smoking cessation counseling and complete questionnaires regarding their smoking behavior and psychological state. A post-trial physical will be conducted upon completion of Week 9. Monthly follow-up phone interviews will be conducted for 5 months and subjects will be re-assessed in the NDC for a 6-month follow-up.
Trial Objectives
- To determine if combination of selegiline hydrochloride and NRT (full substitution to tobacco) is superior to NRT alone + placebo (partial substitution) for smoking cessation in nicotine dependent smokers.
- The primary hypothesis is that full substitution (selegiline + NRT) will be superior to placebo + NRT for achievement of 7-day point prevalence smoking abstinence rates at the end of trial abstinence rates (Day 49-56) assessment in nicotine-dependent cigarette smokers.
- Secondary hypothesis 1a is that full substitution (selegiline + NRT) will be superior to NRT for achievement of last four weeks of trial (Days 29-56) smoking abstinence rates in nicotine-dependent cigarette smokers.
- Secondary hypothesis 1b is that full substitution (selegiline + NRT) will be superior to NRT for achievement 6-month post target quit date smoking abstinence rates in nicotine-dependent cigarette smokers.
- To determine if treatment retention and study medication compliance will be higher in the full substitution (selegiline + NRT) group as compared to the NRT group during the 8-week smoking cessation trial. Hypothesis 2 is that treatment retention and study medication compliance will be higher in the full substitution (selegiline + NRT) group as compared to the NRT group during the 8-week smoking cessation trial.
- To determine if full substitution (selegiline + NRT) reduces nicotine craving and withdrawal symptoms as compared to NRT group during the 8-week smoking cessation trial. Hypothesis 3 is that full substitution treatment will lead to significant reductions in tobacco withdrawal and craving ratings compared to NRT group.
- To determine adverse events profile in nicotine-dependent smokers of the combination of selegiline and NRT as compared to NRT.
Hypothesis 4 is that selegiline in combination with NRT will be well-tolerated and that rates of adverse events will not be significantly different between subjects assigned to full substitution as compared to NRT group.
- Conditions
- Nicotine Dependence
- Being tested
- Selegiline + nicotine replacement therapy, placebo + nicotine replacement therapy
- Keywords
- smoking, nicotine dependence, double-blind, placebo-controlled, randomized, full substitution therapy, selegiline
- 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.
Selegiline + nicotine replacement therapyDrug
Participants will begin selegiline once a day during Week 1, and dose will be graduated to full study dosage (10 mg/day) by adding an evening intake (a.m. and p.m. dosing) for Weeks 2-8. Day 15 of the trial represents target quit day and the transdermal nicotine patch (21 mg/24hr) will be applied at this time. Patches will be worn in conjunction with study medication for Weeks 3-8, after which the patch will be removed and study medication tapered throughout Week 9.
placebo + nicotine replacement therapyDrug
Participants will begin placebo once a day during Week 1, and dose will be graduated to full study dosage (10 mg/day) by adding an evening intake (a.m. and p.m. dosing) for Weeks 2-8. Day 15 of the trial represents target quit day and the transdermal nicotine patch (21 mg/24hr) will be applied at this time. Patches will be worn in conjunction with study medication for Weeks 3-8, after which the patch will be removed and study medication tapered throughout Week 9.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Selegiline + nicotine replacement therapy |
| 2 | Placebo comparator | Not described Receives: Drug: placebo + nicotine replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm)
Measured: 9 weeks
Secondary outcomes (6)
Last four weeks of Trial Continuous smoking abstinence rates (verified by CO < 10 ppm)
Measured: 4 weeks
Seven-day point prevalence smoking abstinence
Measured: end of treatment, six-month follow-up
Treatment retention (based on survival analysis and number of weeks a subject completes in the trial)
Measured: upon completion
Time line follow back for cigarettes smoked, alcohol and caffeinated beverage use
Measured: Weeks 1-8; six-month follow-up
Tobacco craving as assessed by Tiffany scale for smoking urges
Measured: Weeks 1, 4 and 8; 6-month follow-up
DSM-IV nicotine withdrawal symptom checklist
Measured: Weeks 1, 4 and 8; 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startJul 2007
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: Preliminary results did not support the utility of combining selegeline + NRT.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 Centre for Addiction and Mental HealthThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Tobacco Control Research Initiative
- Responsible party
- Principal investigator, Bernard Le Foll, Centre for Addiction and Mental Health
- Investigators
- Bernard Le Foll, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390923
- Sponsor's protocol ID
- 170/2006
- Status last verified
- Aug 2013
- First submitted
- 19 Oct 2006
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Henningfield JE, Goldberg SR. Nicotine as a reinforcer in human subjects and laboratory animals. Pharmacol Biochem Behav. 1983 Dec;19(6):989-92. doi: 10.1016/0091-3057(83)90405-7.
PubMed 6657732Stolerman IP, Shoaib M. The neurobiology of tobacco addiction. Trends Pharmacol Sci. 1991 Dec;12(12):467-73. doi: 10.1016/0165-6147(91)90638-9.
PubMed 1792691Caggiula AR, Donny EC, White AR, Chaudhri N, Booth S, Gharib MA, Hoffman A, Perkins KA, Sved AF. Cue dependency of nicotine self-administration and smoking. Pharmacol Biochem Behav. 2001 Dec;70(4):515-30. doi: 10.1016/s0091-3057(01)00676-1.
PubMed 11796151Fowler JS, Volkow ND, Wang GJ, Pappas N, Logan J, Shea C, Alexoff D, MacGregor RR, Schlyer DJ, Zezulkova I, Wolf AP. Brain monoamine oxidase A inhibition in cigarette smokers. Proc Natl Acad Sci U S A. 1996 Nov 26;93(24):14065-9. doi: 10.1073/pnas.93.24.14065.
PubMed 8943061Robinson TE, Berridge KC. The neural basis of drug craving: an incentive-sensitization theory of addiction. Brain Res Brain Res Rev. 1993 Sep-Dec;18(3):247-91. doi: 10.1016/0165-0173(93)90013-p.
PubMed 8401595Robinson TE, Berridge KC. Incentive-sensitization and addiction. Addiction. 2001 Jan;96(1):103-14. doi: 10.1046/j.1360-0443.2001.9611038.x.
PubMed 11177523Hajizadeh 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 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence
- ClinicalTrials.gov ID
- NCT00390923
- Acronym / sponsor ID
- 170/2006
- Conditions
- Nicotine Dependence
- Keywords
- smoking, nicotine dependence, double-blind, placebo-controlled, randomized, full substitution therapy, selegiline
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary results did not support the utility of combining selegeline + NRT.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Tobacco Control Research Initiative
- Study start
- Jul 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 23 Oct 2006 (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.
This study will test a new medication strategy designed to help smokers quit. It will combine selegiline, a drug currently approved and available for the treatment of Parkinson's disease, with a nicotine skin patch. Forty nicotine-dependent smokers will enrolled in this study. Twenty will receive placebo (inactive pill) plus nicotine patch, and twenty will receive selegiline plus nicotine patch. Once enrolled in the study, subjects will visit the Nicotine Dependence Clinic at CAMH on a weekly basis for assessment of smoking behavior, a brief health check, collection of breath and urine samples (necessary to drug levels and nicotine levels), and receive brief individual counseling designed to help them stop smoking. The medication phase of this study lasts 9 weeks. A follow-up visit will be conducted six months after trial completion. At that point, health and behavioral measures will be re-assessed.
Detailed description
This pilot study utilizes a double-blind, two-armed design to evaluate the efficacy of combining oral selegiline with transdermal nicotine patch for smoking cessation in 40 nicotine-dependent smokers. After successful completion of 3 screening visits (to ensure medical and psychiatric eligibility criteria are met), subjects will be randomized into one of two experimental groups:
- selegiline (10 mg/day) + NRT (21 mg/24 hr)
- matching placebo + NRT (21 mg/24 hr)
Randomization will be performed through the use a random number list to generate 50% selegiline/50% placebo and also 50% male/50% female within each of those treatment groups.
Participants will begin selegiline (or placebo) once a day during Week 1, and dose will be graduated to full study dosage (10 mg/day) by adding an evening intake (a.m. and p.m. dosing) for Weeks 2-8. Day 15 of the trial represents target quit day and the transdermal nicotine patch (21 mg/24hr) will be applied at this time. Patches will be worn in conjunction with study medication for Weeks 3-8, after which the patch will be removed and study medication tapered throughout Week 9.
Subjects will present weekly to the Nicotine Dependence Clinic where they will provide breath, urine and blood samples as required, receive brief smoking cessation counseling and complete questionnaires regarding their smoking behavior and psychological state. A post-trial physical will be conducted upon completion of Week 9. Monthly follow-up phone interviews will be conducted for 5 months and subjects will be re-assessed in the NDC for a 6-month follow-up.
Trial Objectives
- To determine if combination of selegiline hydrochloride and NRT (full substitution to tobacco) is superior to NRT alone + placebo (partial substitution) for smoking cessation in nicotine dependent smokers.
- The primary hypothesis is that full substitution (selegiline + NRT) will be superior to placebo + NRT for achievement of 7-day point prevalence smoking abstinence rates at the end of trial abstinence rates (Day 49-56) assessment in nicotine-dependent cigarette smokers.
- Secondary hypothesis 1a is that full substitution (selegiline + NRT) will be superior to NRT for achievement of last four weeks of trial (Days 29-56) smoking abstinence rates in nicotine-dependent cigarette smokers.
- Secondary hypothesis 1b is that full substitution (selegiline + NRT) will be superior to NRT for achievement 6-month post target quit date smoking abstinence rates in nicotine-dependent cigarette smokers.
- To determine if treatment retention and study medication compliance will be higher in the full substitution (selegiline + NRT) group as compared to the NRT group during the 8-week smoking cessation trial. Hypothesis 2 is that treatment retention and study medication compliance will be higher in the full substitution (selegiline + NRT) group as compared to the NRT group during the 8-week smoking cessation trial.
- To determine if full substitution (selegiline + NRT) reduces nicotine craving and withdrawal symptoms as compared to NRT group during the 8-week smoking cessation trial. Hypothesis 3 is that full substitution treatment will lead to significant reductions in tobacco withdrawal and craving ratings compared to NRT group.
- To determine adverse events profile in nicotine-dependent smokers of the combination of selegiline and NRT as compared to NRT.
Hypothesis 4 is that selegiline in combination with NRT will be well-tolerated and that rates of adverse events will not be significantly different between subjects assigned to full substitution as compared to NRT group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Selegiline + nicotine replacement therapy |
| 2 | Placebo comparator | Drug: placebo + nicotine replacement therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Meet DSM-IV criteria for nicotine dependence with FTND score > 5.
- Smoke at least 15 cigarettes (3/4 pack) daily (averaged over 1 week, in the past 1 month).
- At the time of initial evaluation, are motivated to quit smoking in the next 30 days.
- Have made at least one unsuccessful attempt to quit smoking in the past year.
- At baseline, have expired breath CO level > 10.
Key exclusion criteria (9 listed)
- Have present or past diagnoses of schizophrenia, bipolar disorder, PTSD, BPD or major depressive illness.
- Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 6 months prior to randomization into the trial (based on clinical evaluation including self-report, and confirmed by positive urine).
- Demonstrate serious medical conditions (i.e. abnormal liver function [as evidenced by AST, ALT or bilirubin values 2x ULN], unstable cardiovascular disease, significant blood abnormalities).
- Exhibit or have history of clinical hypertension.
- Exhibit active peptic ulcer disease.
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 + nicotine replacement therapyParticipants will begin selegiline once a day during Week 1, and dose will be graduated to full study dosage (10 mg/day) by adding an evening intake (a.m. and p.m. dosing) for Weeks 2-8. Day 15 of the trial represents target quit day and the transdermal nicotine patch (21 mg/24hr) will be applied at this time. Patches will be worn in conjunction with study medication for Weeks 3-8, after which the patch will be removed and study medication tapered throughout Week 9. | Drug | 1 |
| placebo + nicotine replacement therapyParticipants will begin placebo once a day during Week 1, and dose will be graduated to full study dosage (10 mg/day) by adding an evening intake (a.m. and p.m. dosing) for Weeks 2-8. Day 15 of the trial represents target quit day and the transdermal nicotine patch (21 mg/24hr) will be applied at this time. Patches will be worn in conjunction with study medication for Weeks 3-8, after which the patch will be removed and study medication tapered throughout Week 9. | Drug | 2 |
Primary outcome
Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm)
Time frame: 9 weeks
6 secondary outcomes
Last four weeks of Trial Continuous smoking abstinence rates (verified by CO < 10 ppm)
Time frame: 4 weeks
Seven-day point prevalence smoking abstinence
Time frame: end of treatment, six-month follow-up
Treatment retention (based on survival analysis and number of weeks a subject completes in the trial)
Time frame: upon completion
Time line follow back for cigarettes smoked, alcohol and caffeinated beverage use
Time frame: Weeks 1-8; six-month follow-up
Tobacco craving as assessed by Tiffany scale for smoking urges
Time frame: Weeks 1, 4 and 8; 6-month follow-up
DSM-IV nicotine withdrawal symptom checklist
Time frame: Weeks 1, 4 and 8; 6-month follow-up
Results and safety
The study was stopped early (reason given: Preliminary results did not support the utility of combining selegeline + NRT.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
- Background: PubMed 6657732Henningfield JE, Goldberg SR. Nicotine as a reinforcer in human subjects and laboratory animals. Pharmacol Biochem Behav. 1983 Dec;19(6):989-92. doi: 10.1016/0091-3057(83)90405-7.
- Background: PubMed 1792691Stolerman IP, Shoaib M. The neurobiology of tobacco addiction. Trends Pharmacol Sci. 1991 Dec;12(12):467-73. doi: 10.1016/0165-6147(91)90638-9.
- Background: PubMed 11796151Caggiula AR, Donny EC, White AR, Chaudhri N, Booth S, Gharib MA, Hoffman A, Perkins KA, Sved AF. Cue dependency of nicotine self-administration and smoking. Pharmacol Biochem Behav. 2001 Dec;70(4):515-30. doi: 10.1016/s0091-3057(01)00676-1.
- Background: PubMed 8943061Fowler JS, Volkow ND, Wang GJ, Pappas N, Logan J, Shea C, Alexoff D, MacGregor RR, Schlyer DJ, Zezulkova I, Wolf AP. Brain monoamine oxidase A inhibition in cigarette smokers. Proc Natl Acad Sci U S A. 1996 Nov 26;93(24):14065-9. doi: 10.1073/pnas.93.24.14065.
- Background: PubMed 8401595Robinson TE, Berridge KC. The neural basis of drug craving: an incentive-sensitization theory of addiction. Brain Res Brain Res Rev. 1993 Sep-Dec;18(3):247-91. doi: 10.1016/0165-0173(93)90013-p.
- Background: PubMed 11177523Robinson TE, Berridge KC. Incentive-sensitization and addiction. Addiction. 2001 Jan;96(1):103-14. doi: 10.1046/j.1360-0443.2001.9611038.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.
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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.
Bernard Le Foll, MD, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selegiline + nicotine replacement therapy in people with Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 29 Aug 2013. 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 Canada. 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.
Are results available for this study?
The study was stopped early (reason given: Preliminary results did not support the utility of combining selegeline + NRT.). Results are not available in the source record.
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?
Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) (time frame: 9 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 NCT00390923, which also lists 7 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 29 Aug 2013.