Study of Nicotine Patch in Pregnancy (SNIPP)

NCT00507975 | Completed Phase 3

• 1 other identifier: P060604
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Smoking

Keywords

Smoking; pregnancy; newborn; birth weight; nicotine patch; birth

Outcome Measures

Primary Outcomes (1)

• Continuous and complete smoking abstinence of the pregnant women from the first administration of nicotine/placebo patch until delivery.

  from the first administration of nicotine/placebo patch until delivery

Secondary Outcomes (6)

• All adverse events occurring during pregnancy

  during pregnancy

• Point prevalence (7-days) smoking abstinence

  7-days smoking abstinence

• Vital signs of the mother and her body weight

  during pregnancy

• Echography results of the foetus

  during the pregnancy

• Birth characteristics of the newborn (Apgar, head circumference, height)

  at the delivery

Study Arms (2)

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.

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.

Drug: nicotine versus placebo

Interventions

nicotine versus placebo DRUG

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.

A; B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Groupe Hospitalier Pitié-Salpétrière, Unité de Recherche Clinique

Paris, 75013, France

Location

Hopital La Pitie Salpetriere

Paris, 75013, France

Location

Related Publications (4)

• 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.

  PMID: 11084187 RESULT

• Benowitz 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.

  PMID: 15203821 RESULT

• Berlin 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.

  PMID: 26160457 DERIVED

• Berlin 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.

  PMID: 24627552 DERIVED

MeSH Terms

Conditions

Smoking; Birth Weight

Condition Hierarchy (Ancestors)

Behavior; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ivan BERLIN, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 27, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 13, 2012

Record last verified: 2007-07

Locations

FR (2)