Tobacco Intervention in Primary Care Treatment Opportunities for Providers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-06-15

Brief Summary

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The purpose of this study is to evaluate the use of "sampling" of smoking cessation medications (nicotine patches and lozenges) among smokers seen in primary care settings. Half of study participants will be provided with samples of medication, to use however they wish; the other half will not be provided with these samples. All smokers will be advised to quit through routine contact with their physician. After the primary care contact, all participants will be contacted by phone for three brief follow-up interviews, which will involve answering questionnaires about their smoking habits.

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Detailed Description

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Conditions

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Smoking Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Nicotine Replacement Therapy (NRT)

2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch

Group Type EXPERIMENTAL

Nicotine Replacement Therapy (NRT) Sampling

Intervention Type OTHER

2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch

Ask, Advise, Refer (physician brief advice)

Group Type ACTIVE_COMPARATOR

Ask, Advise, Refer (physician brief advice)

Intervention Type BEHAVIORAL

Interventions

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Nicotine Replacement Therapy (NRT) Sampling

2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch

Intervention Type OTHER

Ask, Advise, Refer (physician brief advice)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age \>=18
* daily (25+ days within past 30) cigarette smoker of \>5 cigs/day
* English speaking
* recruited through primary care sites aligned with study

Exclusion Criteria

\- no FDA contraindications for use of NRT:

1. not pregnant, breastfeeding, or planning to become pregnant
2. no recent (past 3 months) cardiovascular trauma: MI, stroke

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No