Tobacco Intervention in Primary Care Treatment Opportunities for Providers

Not Applicable

Completed

• Conditions: Smoking Cessation; Smoking
• Interventions: Behavioral: Ask, Advise, Refer (physician brief advice); Other: Nicotine Replacement Therapy (NRT) Sampling

• Registration Number: NCT02096029
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Study Start: 2014-07
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-15
• Results First Submitted: 2019-06-13
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-12
• Last Update Submitted: 2019-07-12
• Results First Posted: 2019-08-07
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1278

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ask, Advise, Refer (physician brief advice)	Ask, Advise, Refer (physician brief advice)	Ask, Advise, Refer (physician brief advice)
Nicotine Replacement Therapy (NRT)	Nicotine Replacement Therapy (NRT) Sampling	2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence	From study enrollment through end of six-month follow up

Secondary Outcome Measures

Name	Time	Method
Any Self-defined Attempt to Stop Smoking Cigarettes	From study enrollment through end of six-month follow up
Use of Any Smoking Cessation Medication	From study enrollment through end of six-month follow up

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States