Unconventional Financial Incentives for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Bad is Stronger Than Good: Unconventional Financial Incentives for Smoking Cessation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03608852
• Other study ID #: 1160736-1
• Status: Not yet recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Smoking Cessation

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