Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03608852
Other study ID # 1160736-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date August 1, 2019

Study information

Verified date July 2018
Source Miami VA Healthcare System
Contact Isabel A Vital, MD
Phone 305-575-7000
Email isabel.vital@va.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The proposed study is a randomized study of actively smoking veterans cared for at the Miami VA Medical Center. Subjects are randomized into 2 groups and will all receive a regimen of nicotine replacement therapy (NRT) standardized to their smoking habit. Subjects are followed biweekly for smoking cessation by using biochemical tests (exCO and COHb) to determine smoking abstinence. The first group called the Banked-Money Group will have $50 placed in a 'bank account' for every clinic visit where their tests reveal abstinence from smoking. As a modified commitment contract, the Banked-Money Group can only withdraw the accrued money at the end of the trial if they complete the trial by quitting smoking for the entire 6 months. The second group called the Reward Group will directly receive $50 for every clinic visit where their tests reveal abstinence from smoking.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date August 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Enrollment criteria include subjects 18 years of age or older, currently smoking at least a half a pack of cigarettes a day, who have at least a ten-pack year smoking history, are interested in quitting smoking, agree to submit to exhaled breath and ABG analysis and have reliable means of visiting the clinic every two weeks. Subjects must be able to tolerate NRT including patches and lozenges and meet with the VA smoking cessation counselor.

Exclusion Criteria:

Subjects will not be enrolled if they are currently taking varenicline as the VA disallows concurrent use of varenicline and NRT.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Miami VA Healthcare System

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking cessation rate The primary outcome for this study is to compare smoking cessation rates between smokers who received one of two financial incentive strategies in addition to standard of care NRT and counseling. 1 year
Secondary Household income We will determine whether household income affect quit rates. 1 year
Secondary Smoking habits We will determine whether smoking habits affect quit rates. 1 year
Secondary Nicotine dependence We will determine whether nicotine dependence affect quit rates. 1 year
Secondary Nicotine withdrawal symptoms We will determine whether nicotine withdrawal symptoms affect quit rates. 1 year
Secondary Anxiety / Depression We will determine whether anxiety and / or depression affect quit rates. 1 year
See also
  Status Clinical Trial Phase
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT04617444 - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function N/A
Completed NCT02796391 - Facilitating Smoking Cessation With Reduced Nicotine Cigarettes Phase 2
Completed NCT03397511 - Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City N/A
Not yet recruiting NCT05188287 - A Culturally Tailored Smartphone Application for African American Smokers N/A
Recruiting NCT05264428 - The Effect of Honey on Lessening the Withdrawal Symptoms N/A
Recruiting NCT05846841 - Personalized Tobacco Treatment in Primary Care (MOTIVATE) N/A
Completed NCT04133064 - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study N/A
Completed NCT03187730 - Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants Phase 4
Completed NCT03474783 - To Explore the Factors Affecting the Effectiveness of Smoking Cessation N/A
Completed NCT04635358 - Feasibility Study of Smoking Cessation for the Staff of a Hospital Center N/A
Terminated NCT03670264 - BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation N/A
Not yet recruiting NCT06307496 - VIDeOS for Smoking Cessation N/A
Completed NCT02905656 - Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit N/A
Completed NCT02997657 - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT02239770 - Pharmacokinetics of Nicotine Film in Smokers N/A
Completed NCT02562521 - A Smoking Cessation Intervention for Yale Dining Employees Phase 4
Recruiting NCT02422914 - Benefits of Tobacco Free Cigarette N/A