NCT01368016

Brief Summary

A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
346

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

April 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

3 months

First QC Date

June 6, 2011

Last Update Submit

July 6, 2012

Conditions

Tobacco Dependence

Keywords

Smoking CessationNicotine Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Area Under the Curve (AUC): Urges to Smoke-vs-Time

    Area under urges to smoke-vs.-time curve

    During 5 hours post-dose

Secondary Outcomes (1)

  • Amount of Nicotine Released

    30 minutes

Study Arms (2)

Experimental NRT

EXPERIMENTAL

A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits.

Drug: Nicotine

Nicotine GUM

ACTIVE COMPARATOR

A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits.

Drug: Nicotine

Interventions

NicotineDRUG

A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits

Also known as: Not yet marketed
Experimental NRT

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index (BMI) between 17.5 and 32.0 kg/m2 and a total body weight of at least 55.0 kg.
  • Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
  • A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

You may not qualify if:

  • Pregnancy, lactation or intended pregnancy.
  • Treatment with an investigational product within one month preceding the first dose of study medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Pharmacology, McNeil AB

Lund, SE-222 20, Sweden

Location

Karolinska Trial Alliance (KTA), University Hospital Huddinge

Stockholm, SE-141 86, Sweden

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmoking Cessation

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Elisabeth Kruse, PhD

    McNeil AB

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2011

First Posted

June 7, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

SE(2)