SmokingPhase 3SNIPPNCT00507975
Study of Nicotine Patch in Pregnancy (SNIPP)
A Phase 3 study of Smoking, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
There are no established evidences as to the effectiveness in smoking pregnant women of nicotine patches in increasing birth weight, smoking abstinence during pregnancy and concerning the safety their for the fetus/newborn. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Smoking
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2007to Nov 2012
- Phase
- Phase 3
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- smoking pregnant woman unable to quit smoking during the first 3 months of pregnancy
- smoking ≥ 5 cigaret/day despite standard medical advice and cognitive-behavioral counselling
- aged ≥ 18 years
- health insured
- motivated to stop smoking; motivation score ≥ 5 on a scale ranging from 0 to 10
- amenorrhea of 9 to 20 weeks
- having signed the written informed consent
Who cannot join
- non-pregnant women
- men
- Pregnant woman:
- who does not agree to use a nicotine or placebo patch
- with presence of chronic psychiatric comorbidity treated continuously by antidepressant, neuroleptic or anxiolytic
- with skin disorder contraindicating the use of a transdermal patch
Show all 9Show fewer
- with known hypersensitivity to transdermal patch or to one of its constituents
- using other nicotine containing pharmaceutical products (gum, lozenge, inhaler, sublingual tablets)
- using other forms of tobacco than cigaret (cigaret, pipe or any form of smokeless tobacco)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Groupe Hospitalier Pitié-Salpétrière, Unité de Recherche Clinique
Paris, 75013
Hopital La Pitie Salpetriere
Paris, 75013
About this study
Official title: Assessment of the Effectiveness of Nicotine Replacement Therapies (Nicotine Patches Delivering Nicotine 16 h/24 h) in 400 Pregnant Smokers. Randomized, Placebo-controlled, Multicenter, National Study. The SNIPP.
There are no established evidences as to the effectiveness in smoking pregnant women of nicotine patches in increasing birth weight, smoking abstinence during pregnancy and concerning the safety their for the fetus/newborn. Moreover, recent studies have shown that the metabolism of nicotine is speeded up in pregnant women suggesting that dose adaptation may be necessary in this population. The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.
Read the detailed description
Smoking during pregnancy is one of the main causes of low birth weight and several disorders during pregnancy involving the mother, the fetus/newborn or both. Only one previous study assessed the efficacy of 16 hours nicotine patch proposed for 3 months in pregnant women for smoking cessation. This study seemed to be underpowered and the compliance was very poor. However, some benefit on birth weight was observed.
The aim of the present study is to demonstrate whether nicotine replacement therapy with 16 h nicotine patch every day increases or not birth weight and abstinence during pregnancy in smoking women. Secondarily, it is aimed to provide descriptive information about the safety of nicotine patches in pregnant women.
This is a double blind, randomized, placebo controlled study. With 200 pregnant women in each arm it will have sufficient power to conclude about differences in birth weight and maternal abstinence between nicotine and placebo.
Women are recruited by health care professionals and directed to the obstetrical departments having previously been agreed to participate in the study.
After a grace period of one month without pharmacological treatment, the pregnant women are randomized into the placebo (N=200) or the nicotine group (N=200). Treatment duration is from randomization till delivery meaning a maximum length of drug/placebo exposure of 6 month during pregnancy. No treatment is started earlier than 3 months' pregnancy. Women may optionally continue their treatment for at least up to 2 months after birth.
At the inclusion visit when the women are smoking, saliva cotinine is collected and determined. The first dose of nicotine is adapted according to the saliva cotinine when smoking to obtain approximately 100 % substitution. A second saliva cotinine determination is realized 2 weeks later and at the next visit nicotine's daily dose is determined according to this second saliva cotinine results for the whole duration of pregnancy. This dose-adaptation is necessary to avoid as far as possible under- and overdosing of nicotine.
The women undergo monthly visits as it is usual and recommended in France. They are followed as well as their newborn up to 2 months after birth.
During the visits standard obstetrical information along with smoking related information and the routinely realized echography data are recorded and birth characteristics collected.
In a subgroup of pregnant women having given their written informed consent and undergoing an amniocentesis for medical reasons, nicotine and cotinine in amniotic fluid will be determined.
In a subgroup of pregnant women having given their written informed consent and breast feeding their baby during the 2 months period after birth, nicotine and cotinine in maternal milk are determined.
There are 2 main outcome comparisons between the nicotine patch and the placebo patch groups: birth weight and maternal continuous, complete abstinence during pregnancy
- Conditions
- Smoking
- Being tested
- nicotine versus placebo
- Keywords
- Smoking, pregnancy, newborn, birth weight, nicotine patch, birth
- Medical subject headings
- Smoking, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotine versus placeboDrug
The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother. Receives: Drug: nicotine versus placebo |
| B | Experimental | The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother. Receives: Drug: nicotine versus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous and complete smoking abstinence of the pregnant women from the first administration of nicotine/placebo patch until delivery.
Measured: from the first administration of nicotine/placebo patch until delivery
Secondary outcomes (6)
All adverse events occurring during pregnancy
Measured: during pregnancy
Point prevalence (7-days) smoking abstinence
Measured: 7-days smoking abstinence
Vital signs of the mother and her body weight
Measured: during pregnancy
Echography results of the foetus
Measured: during the pregnancy
Birth characteristics of the newborn (Apgar, head circumference, height)
Measured: at the delivery
Compliance with treatment
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan BERLIN, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507975
- Sponsor's protocol ID
- P060604
- Acronym
- SNIPP
- Status last verified
- Jul 2007
- First submitted
- 25 Jul 2007
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Wisborg K, Henriksen TB, Jespersen LB, Secher NJ. Nicotine patches for pregnant smokers: a randomized controlled study. Obstet Gynecol. 2000 Dec;96(6):967-71. doi: 10.1016/s0029-7844(00)01071-1.
PubMed 11084187Benowitz N, Dempsey D. Pharmacotherapy for smoking cessation during pregnancy. Nicotine Tob Res. 2004 Apr;6 Suppl 2:S189-202. doi: 10.1080/14622200410001669169. No abstract available.
PubMed 15203821Berlin I, Singleton EG, Heishman SJ. Cross validation of the prognostic and diagnostic utility of tobacco craving in a general and a pregnant sample of treatment-seeking smokers. Drug Alcohol Depend. 2015 Sep 1;154:174-83. doi: 10.1016/j.drugalcdep.2015.06.034. Epub 2015 Jun 29.
PubMed 26160457Berlin I, Grange G, Jacob N, Tanguy ML. Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy. BMJ. 2014 Mar 11;348:g1622. doi: 10.1136/bmj.g1622.
PubMed 24627552
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Nicotine Replacement Therapies (Nicotine Patches Delivering Nicotine 16 h/24 h) in 400 Pregnant Smokers. Randomized, Placebo-controlled, Multicenter, National Study. The SNIPP.
- ClinicalTrials.gov ID
- NCT00507975
- Acronym / sponsor ID
- SNIPP / P060604
- Conditions
- Smoking
- Keywords
- Smoking, pregnancy, newborn, birth weight, nicotine patch, birth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 27 Jul 2007 (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.
There are no established evidences as to the effectiveness in smoking pregnant women of nicotine patches in increasing birth weight, smoking abstinence during pregnancy and concerning the safety their for the fetus/newborn. Moreover, recent studies have shown that the metabolism of nicotine is speeded up in pregnant women suggesting that dose adaptation may be necessary in this population. The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.
Detailed description
Smoking during pregnancy is one of the main causes of low birth weight and several disorders during pregnancy involving the mother, the fetus/newborn or both. Only one previous study assessed the efficacy of 16 hours nicotine patch proposed for 3 months in pregnant women for smoking cessation. This study seemed to be underpowered and the compliance was very poor. However, some benefit on birth weight was observed.
The aim of the present study is to demonstrate whether nicotine replacement therapy with 16 h nicotine patch every day increases or not birth weight and abstinence during pregnancy in smoking women. Secondarily, it is aimed to provide descriptive information about the safety of nicotine patches in pregnant women.
This is a double blind, randomized, placebo controlled study. With 200 pregnant women in each arm it will have sufficient power to conclude about differences in birth weight and maternal abstinence between nicotine and placebo.
Women are recruited by health care professionals and directed to the obstetrical departments having previously been agreed to participate in the study.
After a grace period of one month without pharmacological treatment, the pregnant women are randomized into the placebo (N=200) or the nicotine group (N=200). Treatment duration is from randomization till delivery meaning a maximum length of drug/placebo exposure of 6 month during pregnancy. No treatment is started earlier than 3 months' pregnancy. Women may optionally continue their treatment for at least up to 2 months after birth.
At the inclusion visit when the women are smoking, saliva cotinine is collected and determined. The first dose of nicotine is adapted according to the saliva cotinine when smoking to obtain approximately 100 % substitution. A second saliva cotinine determination is realized 2 weeks later and at the next visit nicotine's daily dose is determined according to this second saliva cotinine results for the whole duration of pregnancy. This dose-adaptation is necessary to avoid as far as possible under- and overdosing of nicotine.
The women undergo monthly visits as it is usual and recommended in France. They are followed as well as their newborn up to 2 months after birth.
During the visits standard obstetrical information along with smoking related information and the routinely realized echography data are recorded and birth characteristics collected.
In a subgroup of pregnant women having given their written informed consent and undergoing an amniocentesis for medical reasons, nicotine and cotinine in amniotic fluid will be determined.
In a subgroup of pregnant women having given their written informed consent and breast feeding their baby during the 2 months period after birth, nicotine and cotinine in maternal milk are determined.
There are 2 main outcome comparisons between the nicotine patch and the placebo patch groups: birth weight and maternal continuous, complete abstinence during pregnancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: nicotine versus placeboThe main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother. |
| B | Experimental | Drug: nicotine versus placeboThe main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- smoking pregnant woman unable to quit smoking during the first 3 months of pregnancy
- smoking ≥ 5 cigaret/day despite standard medical advice and cognitive-behavioral counselling
- aged ≥ 18 years
- health insured
- motivated to stop smoking; motivation score ≥ 5 on a scale ranging from 0 to 10
Key exclusion criteria (9 listed)
- non-pregnant women
- men
- who does not agree to use a nicotine or placebo patch
- with presence of chronic psychiatric comorbidity treated continuously by antidepressant, neuroleptic or anxiolytic
- with skin disorder contraindicating the use of a transdermal patch
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 |
|---|---|---|
| nicotine versus placeboThe main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother. | Drug | A, B |
Primary outcome
Continuous and complete smoking abstinence of the pregnant women from the first administration of nicotine/placebo patch until delivery.
Time frame: from the first administration of nicotine/placebo patch until delivery
6 secondary outcomes
All adverse events occurring during pregnancy
Time frame: during pregnancy
Point prevalence (7-days) smoking abstinence
Time frame: 7-days smoking abstinence
Vital signs of the mother and her body weight
Time frame: during pregnancy
Echography results of the foetus
Time frame: during the pregnancy
Birth characteristics of the newborn (Apgar, head circumference, height)
Time frame: at the delivery
Compliance with treatment
Time frame: during the study
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 13 Dec 2012.
- Results publication: PubMed 11084187Wisborg K, Henriksen TB, Jespersen LB, Secher NJ. Nicotine patches for pregnant smokers: a randomized controlled study. Obstet Gynecol. 2000 Dec;96(6):967-71. doi: 10.1016/s0029-7844(00)01071-1.
- Results publication: PubMed 15203821Benowitz N, Dempsey D. Pharmacotherapy for smoking cessation during pregnancy. Nicotine Tob Res. 2004 Apr;6 Suppl 2:S189-202. doi: 10.1080/14622200410001669169. No abstract available.
- Derived from this study: PubMed 26160457Berlin I, Singleton EG, Heishman SJ. Cross validation of the prognostic and diagnostic utility of tobacco craving in a general and a pregnant sample of treatment-seeking smokers. Drug Alcohol Depend. 2015 Sep 1;154:174-83. doi: 10.1016/j.drugalcdep.2015.06.034. Epub 2015 Jun 29.
- Derived from this study: PubMed 24627552Berlin I, Grange G, Jacob N, Tanguy ML. Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy. BMJ. 2014 Mar 11;348:g1622. doi: 10.1136/bmj.g1622.
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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.
Ivan BERLIN, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Smoking, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 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: finished, as of the sponsor's last update on 13 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Continuous and complete smoking abstinence of the pregnant women from the first administration of nicotine/placebo patch until delivery. (time frame: from the first administration of nicotine/placebo patch until delivery). 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 NCT00507975, which also lists 4 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 13 Dec 2012.