NCT02168855

Brief Summary

The purpose of this study is to examine the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent, smokers, and to study the process of relapse in ITS, using Ecological Momentary Assessment (EMA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
505

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

June 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 6, 2020

Completed
Last Updated

May 6, 2020

Status Verified

April 1, 2020

Enrollment Period

3.6 years

First QC Date

June 18, 2014

Results QC Date

January 27, 2020

Last Update Submit

April 24, 2020

Conditions

Smoking

Keywords

Smoking cessationNon-daily smokersEcological Momentary Assessmentnicotine replacement therapy

Outcome Measures

Primary Outcomes (1)

  • Smoking Cessation, Continuous 6-month Abstinence

    Long term abstinence assessed and biochemically validated. The results reported are the number of participants self-reporting continuous abstinence throughout the 6-month, post-quit follow-up period. To be considered abstinent, a participant must have self-reported having not smoked during this period, demonstrated carbon monoxide levels less than or equal to 3 at each study visit, and cotinine values assessed via urinalysis at levels less than or equal to 25 ng/ml.

    up to week 24

Secondary Outcomes (4)

  • Characteristics of Quit and Relapse Process - Craving

    Six-week post-quit period

  • Characteristics of Quit and Relapse Process - Negative Affect

    Six-week post-quit period

  • Characteristics of Quit and Relapse Process - Saw No Smoking Cues

    Six-week post-quit period

  • Characteristics of Quit and Relapse Process - No Others Smoking Nearby

    Six-week post-quit period

Study Arms (2)

Active nicotine gum

ACTIVE COMPARATOR
Drug: active nicotine gumBehavioral: Standard behavioral therapy

Inactive gum

PLACEBO COMPARATOR
Behavioral: Standard behavioral therapy

Interventions

active nicotine gumDRUG

2 mg, standard over-the-counter nicotine replacement therapy gum

Active nicotine gum
Standard behavioral therapyBEHAVIORAL

Standard behavioral therapy for smoking cessation

Active nicotine gumInactive gum

Eligibility Criteria

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

You may qualify if:

  • years old or older
  • Smoking for at least 3 years
  • Smoking non-daily for at least one year (\< or = 27 days/month)
  • Smoke at least weekly
  • Intention to quit smoking within the next month and a desire to receive behavioral and medication treatment
  • Willing and able to come to the laboratory for 8 visits over a 14-week period, as well as a ninth and final visit 6 months after their quit date
  • Willing to monitor behavior via an electronic diary for 8 weeks
  • Able to read and write English (in order to understand questionnaires and study instructions)

You may not qualify if:

  • Regular use of any form of tobacco other than cigarettes
  • Recent or severe mental illness (uncontrolled severe depression or mood symptoms, active hallucinations, and or hospitalization in the past month for a psychiatric condition)
  • Night and/or 'swing' shift work (which complicates EMA schedules)
  • Known plans to relocate or move from the Pittsburgh area within the coming 6 months
  • Received cessation treatment within past year
  • Use of bupropion or varenicline in past 2 months
  • Past use of nicotine gum (to avoid un-blinding)
  • Contraindication to NRT
  • (for women) Current pregnancy or breastfeeding or plan to become pregnant during the next 2 months
  • Member of the same household already participating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Smoking Research Group, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Results Point of Contact

Title
Dr. Brian Primack
Organization
University of Arkansas
bprimack@uark.edu
479-575-3208

Study Officials

  • Brian A Primack, MD, PhD

    University of Pittsburgh, Division of General Internal Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 20, 2014

Study Start

June 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

May 6, 2020

Results First Posted

May 6, 2020

Record last verified: 2020-04

Locations

US(1)