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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01096108
Other study ID # 2008NTLS155
Secondary ID 0901S57761R01 HL
Status Completed
Phase N/A
First received March 29, 2010
Last updated August 21, 2014
Start date April 2010
Est. completion date March 2013

Study information

Verified date August 2014
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Standard Quit and Win contests, in which smokers typically quit for one month in return for the opportunity to win prizes, are simple and easy to implement and may be cost-effective in encouraging smokers to quit. By extending contest length and enhancing counseling content, Quit and Win contests may be more effective at encouraging smoking abstinence.

This study aims to evaluate the efficacy of extended and content-enhanced Quit and Win contests to enhance smoking abstinence at college campuses.


Description:

Participants will be randomized to 1 of 4 treatment groups with varying counseling treatments and contest lengths. All participants receive a 2 week supply of nicotine replacement therapy (NRT) and weekly support emails. Follow-up assessment surveys occur at 1, 3, 4 and 6 months post enrollment.

Participants who have completed the follow-up assessment surveys and self-reported that they are tobacco-free will be asked to provide a urine sample in order to verify abstinence.


Recruitment information / eligibility

Status Completed
Enrollment 1318
Est. completion date March 2013
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Enrolled full or part-time at one of the participating campuses

- Smoke at least 10 days per month

- Intending to be in school for the entire academic year (i.e., next 2 semesters)

- Willing to provide a baseline urine sample to verify smoking status

- Able to read English

- Access to working telephone for phone-based counseling and surveys

- Access to a computer with internet access

- Provide written informed consent

Exclusion Criteria:

- Prior to concurrent enrollment in this study through a different college campus or in a different academic year

- those who have used a cessation aid within the last 7 days

- pregnant or planning to become pregnant in next 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Standard contest (1 month)
Smoking abstinence, 1 prize award (month 1)
Motivational and Problem-Solving
Counseling phone calls
Extended Contests
Smoking abstinence, 3 contest prize awards (contests 1, 2 and 3)

Locations

Country Name City State
United States Masonic Cancer Center, University of Minnesota Minneapolis Minnesota

Sponsors (2)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of extended versus standard quit and win contests The aim is to evaluate the separate and combined efficacy of increased dose of treatment and adding counseling to enhance smoking abstinence among college students 6 Months No
Secondary Efficacy of motivational and problem solving counseling versus no counseling The aim is to 1) determine relative cost-effectiveness of extended incentives and motivational and problem-solving (MAPS) counseling. 2) Examine potential mediators and moderators of intervention effects. 6 Months No
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