Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge

NCT01075659 | Completed Phase 2

• 1 other identifier: NICTDP2011
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking Cessation

Keywords

Smoking Cessation; VAS; Urges to smoke

Outcome Measures

Primary Outcomes (1)

• Areas under the linearly interpolated urges to smoke vs. time curve evaluated in a hierarchical order starting with the 5 minutes' evaluation (AUC5min, AUC3min, AUC1min)

  from time zero following 5 hours of smoking abstinence (baseline), until 5 minutes, until 3 minutes, and until 1 minute, respectively

Secondary Outcomes (4)

• Areas under the linearly interpolated urges to smoke vs. time curve (AUC10min)

  from time zero following 5 hours of smoking abstinence (baseline), until 10 minutes thereafter

• Time to a 25%, 50%, 75%, and 90% reduction from baseline intensity of urges to smoke score

  from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter

• Proportion of subjects reaching 25%, 50%, 75% and 90% reduction of urges to smoke

  from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter

• Study treatment acceptability, evaluated using pair-wise treatment comparisons of ordered categorical-scale assessments

  At the end of three separate visits, at least 36 hours apart

Study Arms (3)

LHN1548

EXPERIMENTAL

Two single doses of an experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.

Drug: Nicotine

2019706

ACTIVE COMPARATOR

Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.

Drug: Nicotine

2020005

ACTIVE COMPARATOR

Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.

Drug: Nicotine

Interventions

Nicotine DRUG

Two single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period

Also known as: Not yet marketed

LHN1548

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Use of NRT, bupropion, or varenicline, or history of a quit attempt later than 3 months before screening visit.
• Treatment with an investigational product, other than those described in the protocol, between 1 month preceding the first treatment visit and the last treatment visit of the study.
• Prior regular use of any of the investigational products.

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (1)

Clinical Pharmacology

Lund, 222 20, Sweden

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Elisabeth Kruse, PhD

  McNeil AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

SE (1)