Tobacco Intervention in Primary Care Treatment Opportunities for Providers

Smoking Cessation Clinical Trial

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Official title:

Brief, Novel Smoking Cessation in Primary Care: A Comparative Effectiveness Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096029
• Other study ID #: Pro00019201
• Secondary ID: 2R01DA021619
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: June 15, 2018

Study information

• Verified date: July 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1278
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

Other:
• Nicotine Replacement Therapy (NRT) Sampling
2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch

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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence		From study enrollment through end of six-month follow up
Secondary	Any Self-defined Attempt to Stop Smoking Cigarettes		From study enrollment through end of six-month follow up
Secondary	Use of Any Smoking Cessation Medication		From study enrollment through end of six-month follow up