NCT02191033

Brief Summary

This study is a randomized-controlled clinical trial which evaluates the efficacy of physician brief advice, nicotine replacement therapy and a 6-week course of text messaging in promoting cigarette smoking in smokers enrolled in college. The primary hypothesis is that smokers receiving physician brief advice, nicotine replacement therapy, and text messaging will have higher quit rates that smokers receiving physician brief advice and nicotine replacement therapy alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

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

July 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 1, 2017

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

1.3 years

First QC Date

July 8, 2014

Results QC Date

April 27, 2017

Last Update Submit

March 30, 2020

Conditions

Keywords

cigarette smokingtobacco use cessation products

Outcome Measures

Primary Outcomes (2)

  • Study Enrollment- Number of Participants Who Join the Study

    We will report the number of persons who join the study.

    baseline

  • Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits.

    We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit.

    6- and 12- weeks

Secondary Outcomes (1)

  • Smoking Abstinence

    6- and 12- weeks

Study Arms (2)

Text messaging

EXPERIMENTAL

Smoking counseling, nicotine patch, text messaging

Behavioral: Smoking counselingBehavioral: Text messagingDrug: Nicotine patch

Standard of care

ACTIVE COMPARATOR

Smoking counseling, nicotine patch

Behavioral: Smoking counselingDrug: Nicotine patch

Interventions

Standard of careText messaging
Text messagingBEHAVIORAL
Text messaging
Standard of careText messaging

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 through 24 years
  • Enrolled as a full/part time college student
  • A current smoker (Have smoked more than 100 cigarettes in their lifetime and now smoke every day or some days)
  • English-speaking
  • Interested in quitting
  • Have a cell phone for personal use with an unlimited text messaging plan.

You may not qualify if:

  • History of hypersensitivity/allergy to nicotine patch;
  • Serious arrhythmias - History of heart disease (myocardial infarction, severe chest pain, or coronary artery disease)
  • Current pregnancy/breastfeeding/plan for pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Connecticut State University

New Haven, Connecticut, 06515, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

This is a pilot and feasibility study.

Results Point of Contact

Title
Deepa Camenga, MD
Organization
Yale University

Study Officials

  • Deepa R Camenga, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2014

First Posted

July 15, 2014

Study Start

January 1, 2015

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

April 1, 2020

Results First Posted

June 1, 2017

Record last verified: 2020-03

Locations