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

July 12, 2019 updated by: Matthew Carpenter, Medical University of South Carolina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicotine Replacement Therapy (NRT)
2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch
Other: Nicotine Replacement Therapy (NRT) Sampling
2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch
Active Comparator: Ask, Advise, Refer (physician brief advice)
Behavioral: Ask, Advise, Refer (physician brief advice)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence
Time Frame: From study enrollment through end of six-month follow up
From study enrollment through end of six-month follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Any Self-defined Attempt to Stop Smoking Cigarettes
Time Frame: From study enrollment through end of six-month follow up
From study enrollment through end of six-month follow up
Use of Any Smoking Cessation Medication
Time Frame: From study enrollment through end of six-month follow up
From study enrollment through end of six-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Matthew J Carpenter, PhD, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

June 15, 2018

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 21, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

July 12, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00019201
  • 2R01DA021619 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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