Smoking CessationPhase 4NCT01474265
Sympathovagal Balance in Smoking Cessation
A Phase 4 study testing Varenicline and Nicorette TX in people with Smoking Cessation, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 1 site in Germany.
Trial summary
This study has the following primary aim: the main objective of this study is to investigate the effects of smoking cessation during quit attempts on sympathovagal balance. These effects will be observed in smokers quitting smoking with pharmacological support or without. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Varenicline and Nicorette TX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Apr 2013
- Phase
- Phase 4
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and Women at the age of 25 to 60 years.
- Group A-D: Smokers willing to quit smoking and a FTNA-result >5.
- Group E: Never-smokers.
- Signed consent after information.
Who cannot join
- formerly known hypersensitivity against one of the used pharmacological interventions or structurally similar drugs or against one of the ingredients.
- participation in another study during this study or within 4 weeks prior to this study.
- Addiction or other circumstances that prevent the patient from estimating the study and the consequences.
- Pregnancy and breast-feeding
- women with childbearing potential, except women that fulfill the following criteria:
- post menopause
Show all 22Show fewer
- postoperative (6 weeks after both-sides ovariectomy with or without hysterectomy)
- regular and correct use of prevention methods (error-rate <1% a year), e.g. implants, depot injections, oral contraceptives, IUP)
- sexual abstinence
- signs that predict a possible non-compliance of the patient
- psoriasis, dermatitis, urticaria
- creatinine-clearance < 30ml/min
- epilepsy
- psychiatric diseases (schizophrenia, bipolar disorders, depression).
- Diseases that increase the sympathetic level (Heart insufficiency, high blood pressure (arteria /pulmonary), obstructive sleeping apnoea, COPD)
- cardiac rhythm disturbances
- myocardial infarction within the last 8 weeks
- polyneuropathy
- diseases that come along with damages of peripheral nerves
- severe or life-threatening diseases (e.g. cancer with life-expectancy < 5 years, terminal kidney-insufficiency)
- treatment with antihypertensive drugs or sympathomimetic substances (e.g.theophyllin) or smoking cessation medication (NRT, Varenicline)
- Other reasons, that make a patient not suitable for the study (estimation of primary investigator)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alterations in the Autonomic Nervous System During Smoking Quit Attempts- Possible Effects of Pharmacological Interventions
This study has the following primary aim:
- the main objective of this study is to investigate the effects of smoking cessation during quit attempts on sympathovagal balance. These effects will be observed in smokers quitting smoking with pharmacological support or without.
Read more
Secondary aims of this study are also:
- the definition of MSNA in smokers and non-smokers
- the investigation of other parameters concerning the autonomic nervous system, like baroreflex-sensitivity, heart rate-variability before and during the quit attempt.
- the definition of withdrawal symptoms and craving before, during and after the quit attempt.
- the investigation of effects of smoking cues on craving and sympathovagal balance
- the investigation of relapse rates after smoking cessation in correlation with the parameters mentioned above.
- Conditions
- Smoking Cessation
- Being tested
- Varenicline, Placebo, Nicorette TX
- Keywords
- smoking cessation, varenicline, sympathovagal balance, quit attempts, MSNA
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
0.5-2 mg per day, oral use
PlaceboDrug
1-2 tablets per day, oral use
Nicorette TXDrug
10-15 mg per day, transdermal use (patches)
| Study group | Role | What they receive |
|---|---|---|
| varenicline placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| varenicline | Active comparator | Not described Receives: Drug: Varenicline |
| Nicorette TX | Active comparator | Not described Receives: Drug: Nicorette TX |
| Nicorette TX optional | Active comparator | Not described Receives: Drug: Nicorette TX |
| control group smokers | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of muscular sympathic nervous activity (MSNA) in bursts / 100 heart beats before and while smoking cessation.
Patients present 7 weeks before their personal smoking-stop-day and participate in the study until week 26 after their personal smoking-stop-day. During that time, MSNA is recorded.
Measured: 33 weeks
Secondary outcomes (4)
Assessment of the basal sympathetic nerve activity in smokers compared to never-smokers
first MSNA is carried out 4 weeks before smoking-stop-day (respectively 6 weeks for group D). second and last MSNA is carried out two days after smoking-stop-day (respectively 2 weeks before smoking-stop-day for group D)
Measured: 33 weeks
Assessment of craving and withdrawal symptoms during smoking cessation
withdrawal symptoms data is collected by phone calls 3,2,1 days before smoking-stop-day, the day itself and 1 day and 11 (12 for group C and D) weeks after smoking-stop-day.
Also the withdrawal symptoms date is collected during each personal examination (means - Pre-Examination, Baseline, Follow I to III).
The data will be collected by reliable questionnaires
Measured: 33 weeks
Assessment of smoking cues on craving and sympathovagal balance
smoking cues will be presented on the first follow-up-measurement to members of group A-D.
Measured: 33 weeks
Assessment of smoking relapse rate
All relapses will be registered to correlate them with the obtained parameters (baroreflex-sensitivity, heartrate-variabilty, MSNA, questionnaires)
Measured: 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Goettingen
- Responsible party
- Sponsor
- Investigators
- Tobias Raupach, MD, Principal investigator, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474265
- Sponsor's protocol ID
- 201102-TR
- Status last verified
- Oct 2017
- First submitted
- 3 Nov 2011
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in the Autonomic Nervous System During Smoking Quit Attempts- Possible Effects of Pharmacological Interventions
- ClinicalTrials.gov ID
- NCT01474265
- Acronym / sponsor ID
- 201102-TR
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, varenicline, sympathovagal balance, quit attempts, MSNA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbHUniversity, hospital or other
- Collaborators
- University Medical Center Goettingen
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Nov 2011 (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 has the following primary aim:
- the main objective of this study is to investigate the effects of smoking cessation during quit attempts on sympathovagal balance. These effects will be observed in smokers quitting smoking with pharmacological support or without.
Secondary aims of this study are also:
- the definition of MSNA in smokers and non-smokers
- the investigation of other parameters concerning the autonomic nervous system, like baroreflex-sensitivity, heart rate-variability before and during the quit attempt.
- the definition of withdrawal symptoms and craving before, during and after the quit attempt.
- the investigation of effects of smoking cues on craving and sympathovagal balance
- the investigation of relapse rates after smoking cessation in correlation with the parameters mentioned above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| varenicline placebo | Placebo comparator | Drug: Placebo |
| varenicline | Active comparator | Drug: Varenicline |
| Nicorette TX | Active comparator | Drug: Nicorette TX |
| Nicorette TX optional | Active comparator | Drug: Nicorette TX |
| control group smokers | No intervention | – |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and Women at the age of 25 to 60 years.
- Group A-D: Smokers willing to quit smoking and a FTNA-result >5.
- Group E: Never-smokers.
- Signed consent after information.
Key exclusion criteria (22 listed)
- formerly known hypersensitivity against one of the used pharmacological interventions or structurally similar drugs or against one of the ingredients.
- participation in another study during this study or within 4 weeks prior to this study.
- Addiction or other circumstances that prevent the patient from estimating the study and the consequences.
- Pregnancy and breast-feeding
- women with childbearing potential, except women that fulfill the following criteria:
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 |
|---|---|---|
| Varenicline0.5-2 mg per day, oral use | Drug | varenicline |
| Placebo1-2 tablets per day, oral use | Drug | varenicline placebo |
| Nicorette TX10-15 mg per day, transdermal use (patches) | Drug | Nicorette TX, Nicorette TX optional |
Primary outcome
Assessment of muscular sympathic nervous activity (MSNA) in bursts / 100 heart beats before and while smoking cessation.
Time frame: 33 weeks
Patients present 7 weeks before their personal smoking-stop-day and participate in the study until week 26 after their personal smoking-stop-day. During that time, MSNA is recorded.
4 secondary outcomes
Assessment of the basal sympathetic nerve activity in smokers compared to never-smokers
Time frame: 33 weeks
Assessment of craving and withdrawal symptoms during smoking cessation
Time frame: 33 weeks
Assessment of smoking cues on craving and sympathovagal balance
Time frame: 33 weeks
Assessment of smoking relapse rate
Time frame: 33 weeks
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 25 Oct 2017.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
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.
Tobias Raupach, MD principal investigator
University Medical Center Goettingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline and Nicorette TX in people with Smoking Cessation, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 1 site in Germany.
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 4 inclusion and 22 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 25 Oct 2017. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Assessment of muscular sympathic nervous activity (MSNA) in bursts / 100 heart beats before and while smoking cessation. (time frame: 33 weeks). It is what the study was designed to measure, not a finding.
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 25 Oct 2017.