Unconventional Financial Incentives for Smoking Cessation

NCT03608852 | Unknown DMC

• 1 other identifier: 1160736-1
• Study Type: observational
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Household income

  1 year

• Smoking habits

  1 year

• Nicotine dependence

  1 year

• Nicotine withdrawal symptoms

  1 year

• Anxiety / Depression

  1 year

Study Arms (2)

Banked-money group

This 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.

Reward group

This group will directly receive $50 for every clinic visit where their tests reveal abstinence from smoking.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The goal of this study is to enroll 36 active smokers

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Miami VA Healthcare System: lead

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Central Study Contacts

Isabel A Vital, MD

CONTACT

305-575-7000; isabel.vital@va.gov

Gisel Urdaneta, MD

CONTACT

305-575-7000; gisel.urdanetacestari@va.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 1, 2018
• Study Start: August 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share