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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02191033
Other study ID # 1404013813
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date August 2016

Study information

Verified date March 2020
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Smoking counseling

Text messaging

Drug:
Nicotine patch


Locations

Country Name City State
United States Southern Connecticut State University New Haven Connecticut

Sponsors (3)

Lead Sponsor Collaborator
Yale University Southern Connecticut State University, University of New Haven

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Study Enrollment- Number of Participants Who Join the Study We will report the number of persons who join the study. baseline
Primary 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 Smoking Abstinence biochemically confirmed point prevalence of self reported past 7-day abstinence 6- and 12- weeks
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