NCT02096029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 7, 2019

Completed
Last Updated

August 7, 2019

Status Verified

July 1, 2019

Enrollment Period

4 years

First QC Date

March 21, 2014

Results QC Date

June 13, 2019

Last Update Submit

July 12, 2019

Conditions

SmokingSmoking Cessation

Keywords

smokingsmoking cessationnicotine replacement therapyprimary carecomparative effectiveness

Outcome Measures

Primary Outcomes (1)

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

    From study enrollment through end of six-month follow up

Secondary Outcomes (2)

  • 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

Study Arms (2)

Nicotine Replacement Therapy (NRT)

EXPERIMENTAL

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

Other: Nicotine Replacement Therapy (NRT) Sampling

Ask, Advise, Refer (physician brief advice)

ACTIVE COMPARATOR

Ask, Advise, Refer (physician brief advice)

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

Interventions

Nicotine Replacement Therapy (NRT) SamplingOTHER

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

Nicotine Replacement Therapy (NRT)
Ask, Advise, Refer (physician brief advice)BEHAVIORAL
Ask, Advise, Refer (physician brief advice)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>=18
  • daily (25+ days within past 30) cigarette smoker of \>5 cigs/day
  • English speaking
  • recruited through primary care sites aligned with study

You may not qualify if:

  • \- no FDA contraindications for use of NRT:
  • not pregnant, breastfeeding, or planning to become pregnant
  • no recent (past 3 months) cardiovascular trauma: MI, stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

  • Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

    PMID: 39868569DERIVED

  • Silvestri NJ, Dahne J, Wahlquist AE, Toll B, Carpenter MJ. Does Medication Sampling Improve Compliance with Brief Advice? Results from a Pragmatic Randomized Clinical Trial. J Smok Cessat. 2021;2021:6638872. doi: 10.1155/2021/6638872. Epub 2021 Mar 16.

    PMID: 33828613DERIVED

MeSH Terms

Conditions

SmokingSmoking Cessation

Interventions

Nicotine Replacement Therapycorticosteroid hormone-induced factorReferral and Consultation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsProfessional PracticeOrganization and AdministrationHealth Services Administration

Results Point of Contact

Title
Amy Boatright, Program Coordinator
Organization
Medical University of South Carolina
boatrigh@musc.edu
843-876-2440

Study Officials

  • Matthew J Carpenter, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 26, 2014

Study Start

July 1, 2014

Primary Completion

June 15, 2018

Study Completion

June 15, 2018

Last Updated

August 7, 2019

Results First Posted

August 7, 2019

Record last verified: 2019-07

Locations

US(1)