Cessation in Non-Daily Smokers

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

505 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-01-31

Brief Summary

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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).

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Detailed Description

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Our aim is to study the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent, smokers (ITS), and to study the process of relapse in ITS, using Ecological Momentary Assessment (EMA). This is a double-blind, randomized, placebo-controlled trial of oral NRT for smoking cessation in ITS. 600 ITS who are interested in quitting will be recruited through multiple channels. Enrollees will be randomized 1:1 to active 2 mg nicotine gum or an inert control gum. Participants will attend 6 sessions with brief behavioral support, with a planned quit day at week 2. Short and long term abstinence will be assessed and biochemically validated. EMA data collection includes two weeks of baseline data on ad lib smoking patterns and 6 weeks of post-quit data. This will capture data on craving, withdrawal, and relapse among ITS, and relate relapse contexts to baseline smoking patterns.

Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active nicotine gum

Group Type ACTIVE_COMPARATOR

active nicotine gum

Intervention Type DRUG

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

Standard behavioral therapy

Intervention Type BEHAVIORAL

Standard behavioral therapy for smoking cessation

Inactive gum

Group Type PLACEBO_COMPARATOR

Standard behavioral therapy

Intervention Type BEHAVIORAL

Standard behavioral therapy for smoking cessation

Interventions

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active nicotine gum

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

Intervention Type DRUG

Standard behavioral therapy

Standard behavioral therapy for smoking cessation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 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)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No