NCT02355665

Brief Summary

The purpose of this study is to assess the efficacy and safety of a novel nicotine product for continuous abstinence from smoking. Efficacy of product will be evaluated by assessments of self-reported abstinence, verified by exhaled carbon monoxide (CO) levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,198

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

8 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

First Submitted

Initial submission to the registry

January 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

January 31, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2016

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

January 8, 2019

Completed
Last Updated

January 8, 2019

Status Verified

December 1, 2018

Enrollment Period

8 months

First QC Date

January 30, 2015

Results QC Date

November 13, 2018

Last Update Submit

December 18, 2018

Conditions

Tobacco Dependence

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6

    Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking

    Week 2 to Week 6

Secondary Outcomes (213)

  • Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12

    Week 2 to Week 12

  • Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26

    Week 2 to Week 26

  • Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4

    Week 2 to Week 4

  • Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8

    Week 2 to Week 8

  • Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16

    Week 2 to Week 16

  • +208 more secondary outcomes

Study Arms (2)

Nicotine

EXPERIMENTAL

Nicotine Spray

Drug: Nicotine Spray

Placebo

PLACEBO COMPARATOR

Placebo to match Nicotine spray

Drug: Placebo

Interventions

Nicotine SprayDRUG

Nicotine Spray

Nicotine
PlaceboDRUG

Placebo to match nicotine spray

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking

You may not qualify if:

  • History of cardiovascular disease, stomach ulcer or diabetes unless physician's written approval is obtained.
  • Use of other forms of tobacco/nicotine containing products other than cigarettes within 30 days before baseline visit.
  • Use of nicotine replacement therapies or other smoking cessation medicines/non-drug therapies within 30 days before the baseline visit.
  • Pregnancy or intending to become pregnant.
  • Hypersensitivity to the product, history of alcohol or substance abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Los Angeles Clinical Trials

Burbank, California, 91505, United States

Location

Radiant Research, Inc

Chicago, Illinois, 60654, United States

Location

University of Maryland

College Park, Maryland, 20742, United States

Location

Radiant Research, Inc.

Akron, Ohio, 44311, United States

Location

Radiant Research

Cincinnati, Ohio, 45249, United States

Location

Radiant Research, Inc

Dallas, Texas, 75231, United States

Location

Radiant Research, Inc

Salt Lake City, Utah, 84123, United States

Location

Related Publications (1)

  • Nides M, Danielsson T, Saunders F, Perfekt R, Kapikian R, Solla J, Leischow SJ, Myers A. Efficacy and Safety of a Nicotine Mouth Spray for Smoking Cessation: A Randomized, Multicenter, Controlled Study in a Naturalistic Setting. Nicotine Tob Res. 2020 Mar 16;22(3):339-345. doi: 10.1093/ntr/nty246.

    PMID: 30452732DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Andrew Myers, MD, Director, Clinical Research
Organization
JNJWorldwide
AMyers3@its.jnj.com
(215) 273-8421 USA EST

Study Officials

  • Andrew Myers, MD

    McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 4, 2015

Study Start

January 31, 2015

Primary Completion

September 30, 2015

Study Completion

February 10, 2016

Last Updated

January 8, 2019

Results First Posted

January 8, 2019

Record last verified: 2018-12

Locations

US(8)