Study of Nicotine Patch in Pregnancy (SNIPP)

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)