Study of Nicotine Replacement Therapy in Pregnancy

NCT00744913 | Withdrawn Phase 3 DMC

• 1 other identifier: 1000010740
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall objective of this study is to assess the effectiveness of NRT (Nicoderm patches) plus counselling treatment in women in the second and third trimester of pregnancy.

Conditions

Smoking Cessation

Keywords

Pregnancy; Women; Nicotine replacement therapy; Smoking cessation

Outcome Measures

Primary Outcomes (1)

• To assess the effectiveness of NRT (Nicoderm patches) at doses of 14 mg/day or 21 mg/day plus counselling treatment

  6 months

Secondary Outcomes (1)

• To compare the effectiveness of counseling and NRT at doses of 14 mg/day or 21 mg/day with counselling alone.

  6 months

Study Arms (2)

1

EXPERIMENTAL

Drug: Nicoderm patches

2

ACTIVE COMPARATOR

Other: Counselling

Interventions

Nicoderm patches DRUG

Women in this group will receive standard counselling and NRT (Nicoderm patches) starting with a dose of 14 mg/day that can be increased to 21 mg/day based on response (smoking cessation) and potential side effects

1

Counselling OTHER

Women in this arm of the study will receive standard counseling only.

2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women who smoke
• Pregnant women after 12 weeks gestation, confirmed by ultrasound
• On the day of the recruitment, women will be at least 18 years old and no older than 40 years old
• Agree to sign consent form and participate in all aspects of the follow-up

You may not qualify if:

• Women who refuse to participate in the study/sign a written consent
• Women with insufficient English language skills to understand the questionnaires and assessment material
• Women with multiple pregnancy
• Women with confirmed cardiac pathology
• Women who receive concurrent treatment with Bupropion
• Congenital malformations visualized by ultrasound
• Objection from the physician caring for the woman to her participation

Sponsors & Collaborators

• The Hospital for Sick Children: lead

MeSH Terms

Conditions

Smoking Cessation

Interventions

Counseling

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Gideon Koren, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of MotherRisk Program, Clinical Pharmacology and Toxicology

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: August 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 15, 2013

Record last verified: 2013-08