Smoking Cessation Aid for Young Smokers

June 30, 2017 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

X-Pack: A Smoking Cessation Aid for Young Smokers

This study, sponsored jointly by the George Washington University School of Public Health and the NICHD, will compare the effectiveness of two self-help quit-smoking programs for young people.

Smokers between 18 and 22 years of age who are interested in quitting smoking may be eligible for this 6-month study. Candidates must be enrolled in school at least part time.

Participants are randomly assigned to one of two treatment groups. Both groups receive a brief counseling session and self-help guide, and one group also receives email counseling related to quitting smoking. All participants have three interviews-one in person at the beginning of the program, one over the phone after 2 months in the program, and one in person after 6 months, at the end of the program. The surveys cover the participant's intentions and behaviors related to smoking cessation and their opinions about the self-help materials. In addition, participants may be asked to provide saliva samples at the beginning and end of the program for verifying smoking status.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

While young smokers have a demonstrated interest in quitting and make frequent quit attempts, they often fail in their quit attempts. This group may benefit from aids which promote higher rates of success in their quit attempts. The lack of promising approaches for adolescent and young adult smoking cessation is a recognized problem.

The goal of this study is to build on previous work in developing a smoking cessation kit for youth, which is based on the principles of social marketing and social cognitive theory. This study aims to test the acceptability and efficacy of the X-Pack intervention. It is our belief that with minimal assistance--in the form of the X-Pack product and supporting e-mails--the quit attempts that young people make can result in long-term abstinence.

The design of this study is a two-arm randomized trial where participants are randomized to the X-Pack condition or to the control condition. Study participants consist of current smokers between the ages of 18-22 who are interested in quitting in the next 6 months. The first 292 participants who meet eligibility criteria will be enrolled in the study and randomized to one of two conditions. Participants in the intervention condition will receive the X-Pack, an in-person counseling session, and supporting e-mails. Participants in the control condition will receive the control materials, Clearing the Air, and an in-person counseling session. Participants will be measured at baseline, 2 and 6 months.

Study Type

Interventional

Enrollment

291

Phase

  • Phase 1

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
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20037
        • GW University Medical Center GW Hospital Center

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 to 22 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA

To be eligible for inclusion, individuals must 1) have smoked at least one cigarette/day in each of the past 7 days, 2) be 18 to 22 years old, 3) be interested in quitting smoking in the next 6 months, 4) be willing to try quitting smoking in the next month, and 5) be enrolled in school at least part-time.

EXCLUSION CRITERIA

None listed.

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: Treatment

Collaborators and Investigators

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

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

May 25, 2004

Study Completion

December 14, 2006

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 19, 2006

First Posted (Estimate)

June 21, 2006

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

December 14, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 999904206
  • 04-CH-N206

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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