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OpenTrials
Completed

NCT Number: NCT02096029

Tobacco Intervention in Primary Care Treatment Opportunities for Providers

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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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine Replacement Therapy (NRT) Sampling

Other

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

Ask, Advise, Refer (physician brief advice)

Behavioral

Primary outcomes

  1. Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence

    Time frame: From study enrollment through end of six-month follow up

Secondary outcomes

  1. Any Self-defined Attempt to Stop Smoking Cigarettes

    Time frame: From study enrollment through end of six-month follow up

  2. Use of Any Smoking Cessation Medication

    Time frame: From study enrollment through end of six-month follow up

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: TipTop

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 26, 2014
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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