Helping Pregnant smokers to quit: A multi-centre study of electronic cigarettes and nicotine patches.

Phase 1

• Conditions: Tobacco dependence/smoking cessation; MedDRA version: 20.0 Level: PT Classification code 10057852 Term: Nicotine dependence System Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 20.0 Level: LLT Classification code 10008374 Term: Cessation of smoking System Organ Class: 100000004869; Therapeutic area: Health Care [N] - Environment and Public Health [N06]

• Registration Number: EUCTR2017-001237-65-GB
• Lead Sponsor: Queen Mary University of London, Joint Research Management Office

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-31
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1140

Inclusion Criteria

Daily smokers
12 to 24 weeks pregnant
Wants help with stopping smoking
Willing to be randomised to use either NRT or EC (to avoid selective drop-out and contamination)
Wiling to receive 6 weekly support calls over the phone plus two follow-up calls
Speaks and reads English to a level that permits data collection via the telephone.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1140
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Known allergic reaction to nicotine skin patches (a contraindication for patch use)
Current daily use of NRT or EC
Taking part in another interventional trial (as per Good Clinical Practice)
Serious medical problem or high-risk pregnancy at time of initial consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified