The Effects of Nicotine withdrawal on Panic-like Response to Breath Holding: A Placebo-Controlled, Double-Blind, Cross-Over Patch Study - Nicotine and BH

• Conditions: healthy current smokers; MedDRA version: 9.1Level: LLTClassification code 10009180

• Registration Number: EUCTR2010-022835-13-IT
• Lead Sponsor: IVERSITA` DEGLI STUDI DI FIRENZE - DIPARTIMENTO DI PSICOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-29
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

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

Inclusion Criteria

- being regular smokers, as defined by smoking at least 10 cigarettes per day for at least one year by self report. - age between 18 and 55 years. - either females and males
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- past history of psychiatric disorders or a current history of Axis I psychiatric disorders, excluding nicotine dependence, based upon their responses to the Mini International Neuropsychiatric Interview (MINI) (Sheenan et al 1994); - at least one first degree relative with panic disorder will be excluded. Indeed, we know that they may have a higher CO2 vulnerability (van Beek et al. 2000); - unstable medical condition; - a history of respiratory disease; - cognitive-behavior psychotherapy during the study; - use of any regular psycho-active drugs (i.e., antidepressant, regular benzodiazepine or non benzodiazepine anxiolytic medication for 4 weeks, or fluoxetine for 5 weeks before the test); - skin diseases or nicotine skin hypersensitivity; - self-reported pregnancy or lactating; - current suicidality; - limited mental competency; - inability to give written informed consent; - current attempts at smoking cessation or reduction.

Study & Design

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