Tobacco Intervention in Primary Care Treatment Opportunities for Providers (TipTop)

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Smoking; Smoking Cessation

Treatments: Behavioral: Ask, Advise, Refer (physician brief advice); Other: Nicotine Replacement Therapy (NRT) Sampling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02096029

Pro00019201

2R01DA021619 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,278 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,278 participants in 2 patient groups

Nicotine Replacement Therapy (NRT)

Experimental group

Description:

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

Treatment:

Other: Nicotine Replacement Therapy (NRT) Sampling

Ask, Advise, Refer (physician brief advice)

Active Comparator group

Description:

Ask, Advise, Refer (physician brief advice)

Treatment:

Behavioral: Ask, Advise, Refer (physician brief advice)