NCT02511704

Brief Summary

The purposes of this study are 1) to determine the pharmacokinetics of nicotine after multiple dose administration by electronic cigarette and 2) to compare the acute effects of multiple dose of nicotine administrated by electronic cigarette compared with those obteined by cigarette.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
Last Updated

July 30, 2015

Status Verified

December 1, 2014

Enrollment Period

1 month

First QC Date

July 28, 2015

Last Update Submit

July 28, 2015

Conditions

Nicotine Use Disorder

Keywords

NicotineElectronic cigaretteCigarette

Outcome Measures

Primary Outcomes (1)

  • Area Under the Concentration-Time Curve (AUC 0-24h)

    Calculation of AUC of the concentrations of nicotine and its metabolites in blood

    From baseline (pre-dose, 0h) to 5, 15, 30, 45, 55, 65, 75, 90, 105, 120 and 24h post-dose

Secondary Outcomes (11)

  • Area Under the Concentration-Time Curve (AUC 0-24h)

    From baseline (pre-dose, 0h) to 55, 120 min, 6, 12 and 24h

  • Area Under the Concentration-Time Curve (AUC 0-24h)

    From baseline (pre-dose, 0h) to 15, 30, 45, 55, 65, 75, 90, 105, 120 min, 6, 12 and 24h

  • Number of Participants with Serious and Non-Serious Adverse Events

    2 days after each substance administration

  • Elimination half-life

    From baseline to 24h post-dose

  • Changes in blood pressure

    From pre-dose (baseline) to 120 min post-dose

  • +6 more secondary outcomes

Study Arms (2)

Electronic cigarette

EXPERIMENTAL

Multiple dose Nicotine 0.8 mg, administrated by electronic cigarette (10 puffs) + Nicotine 0.8 mg, administrated by electronic cigarette (10 puffs) separated by 60 minutes

Drug: Nicotine

Cigarette

ACTIVE COMPARATOR

Multiple dose Nicotine 0.8 mg, administrated by cigarette (10 puffs) + Nicotine 0.8 mg, administrated by cigarette (10 puffs) separated by 60 minutes

Drug: Nicotine

Interventions

NicotineDRUG

Multiple dose nicotine

Also known as: Nhoss®
Electronic cigarette

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Understanding and accepting the study procedures and signing the informed consent.
  • Male adults volunteers (18-45 years old).
  • Clinical history and physical examination demonstrating no organic or psychiatric disorders.
  • The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
  • Present use of nicotine without serious adverse reactions.
  • Smokers ≥ 3 cigarettes/day.

You may not qualify if:

  • Having suffered any cardiovascular and/or respiratory disease in the three months prior to the study start.
  • History of drug dependence (except for nicotine dependence).
  • Daily consumption \>4 standard units of ethanol.
  • Having suffered any organic disease or major surgery in the three months prior to the study start.
  • Blood donation 12 weeks before or participation in other clinical trials with drugs in the previous 12 weeks.
  • History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
  • Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
  • Use of any drug or substance inhibitor of cytochrome P-450-1A6 (CYP1A6) (p.e. raloxifene, coumarins, etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar.

Barcelona, Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Tobacco Use DisorderVaping

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSmokingBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Magi Farre, MD, PhD

    Parc de Salut Mar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2015

First Posted

July 30, 2015

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

July 30, 2015

Record last verified: 2014-12

Locations

ES(1)