Preloading Trial

Phase 1

• Conditions: The IMP will assist smoking cessation in smokers wishing to stop.; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2011-005134-19-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-05
• Study Completion: 2016-05-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1792

Inclusion Criteria

• Smokers aged = 18 years of age (assessed on telephone screening) • Smokers who, in the judgement of the clinician, would be suitable for preloading (assessed on telephone screening and in clinic). • Those seeking NHS support to stop smoking (assessed on telephone screening) and willing to quit in 4 weeks • Those able and willing to comply with study procedures (assessed on telephone screening).
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 1429
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 357

Exclusion Criteria

• Those who are pregnant or breastfeeding (assessed on telephone screening) • Those with extensive dermatitis/other skin disorder that precludes patch use (assessed on telephone and clinic screening) • Those with acute coronary syndrome or stroke within the past three weeks (assessed on telephone screening) • Those with active phaeocromocytoma and uncontrolled hyperthyroidism (assessed on telephone screening)

Study & Design

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