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Unconventional Financial Incentives for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT03608852
Recruitment Status : Not yet recruiting
First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Gregory Holt, Miami VA Healthcare System

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.

Condition or disease
Smoking Cessation

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Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Bad is Stronger Than Good: Unconventional Financial Incentives for Smoking Cessation
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Smoking cessation rate [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Household income [ Time Frame: 1 year ]
    We will determine whether household income affect quit rates.

  2. Smoking habits [ Time Frame: 1 year ]
    We will determine whether smoking habits affect quit rates.

  3. Nicotine dependence [ Time Frame: 1 year ]
    We will determine whether nicotine dependence affect quit rates.

  4. Nicotine withdrawal symptoms [ Time Frame: 1 year ]
    We will determine whether nicotine withdrawal symptoms affect quit rates.

  5. Anxiety / Depression [ Time Frame: 1 year ]
    We will determine whether anxiety and / or depression affect quit rates.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The goal of this study is to enroll 36 active smokers
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608852


Contacts
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Contact: Isabel A Vital, MD 305-575-7000 ext 4816 isabel.vital@va.gov
Contact: Gisel Urdaneta, MD 305-575-7000 ext 4816 gisel.urdanetacestari@va.gov

Sponsors and Collaborators
Miami VA Healthcare System

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Responsible Party: Gregory Holt, Internal Medicine, Miami VA Healthcare System
ClinicalTrials.gov Identifier: NCT03608852     History of Changes
Other Study ID Numbers: 1160736-1
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No