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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022835-13-IT

Enrollment

Registered

2010-10-29

Start date

2010-10-18

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy current smokers MedDRA version: 9.1 Level: LLT Classification code 10009180

Interventions

Trade Name: NIQUITIN CQ*7CER TRANSD21MG/24 Pharmaceutical Form: Transdermal patch INN or Proposed INN: Nicotine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 21-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: study if nicotine withdrawal may increase panic-like response to the challenge;Secondary Objective: clarify if a patogenetic correlation exists between cigarette smoking and anxiety;Primary end point(s): verify if nicotine under withdrawal conditions may produce a panic-like response to the challange more severe than placebo	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026