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Small Financial Incentives to Promote Smoking Cessation (Prevail II)

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ClinicalTrials.gov Identifier: NCT02737566
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : August 6, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The University of Texas Health Science Center, Houston
William Marsh Rice University
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
The primary objectives of this study are 1) to evaluate the longer-term impact of an adjunctive, low-cost financial incentives intervention (relative to standard care) on smoking abstinence rates among socioeconomically disadvantaged individuals participating in a clinic-based smoking cessation program and 2) to identify treatment mechanisms and contextual factors associated with cessation outcomes among intervention participants using both traditional and ecological momentary assessment approaches. Those randomized to the financial incentives intervention will have the opportunity to earn small gift cards for biochemically-verified abstinence through 12 weeks post-quit. We hypothesize that individuals who are randomly assigned to the adjunctive CM intervention will have significantly higher rates of biochemically-verified abstinence at the 26-week post-quit follow-up than those assigned to Usual Care. In addition, we hypothesize that several factors related to socioeconomic disadvantage will be directly associated with non-abstinence, especially greater stress/adversity, limited psychosocial resources, greater negative affect, greater nicotine dependence, and poorer treatment adherence. The primary study endpoints will include self-reported tobacco use/abstinence, expired carbon monoxide (CO) levels (i.e., the amount of carbon monoxide present in an individual's breath when they breathe out), and saliva cotinine levels at 26 weeks post-quit attempt, though smoking status will be assessed at all visits. Traditional questionnaire measurement and ecological momentary assessment (EMA) will be utilized to measure potential treatment mechanisms including motivation, self-efficacy, and treatment adherence. Other variables including stress/adversity, psychosocial resources, negative affect, nicotine dependence, and treatment adherence will also be assessed.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Standard Care + Financial Incentives Other: Standard Care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Small Financial Incentives to Promote Smoking Cessation in Safety Net Hospital Patients
Actual Study Start Date : January 30, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard Care + Financial Incentives
Participants randomized to Standard Care + Financial Incentives for Abstinence will be offered smoking cessation counseling and pharmacotherapy (standard care) and they will have the opportunity to earn small gift cards for biochemically-verified abstinence through 12 weeks post-quit. The amount of the gift cards will escalate each week from the quit date through 4 weeks post-quit with continuous abstinence. Participants who are non-abstinent at any visit may earn incentives for abstinence at the next visit, but the amount will reset to the starting level. Participants may additionally earn an additional gift card for abstinence at the 8 and 12 weeks post-quit visits.
Behavioral: Standard Care + Financial Incentives
Tobacco cessation counseling plus pharmacotherapy and financial incentives for quitting.

Active Comparator: Standard Care
Participants randomized to Standard Care will be offered weekly smoking cessation counseling and pharmacotherapy.
Other: Standard Care
Tobacco cessation counseling plus pharmacotherapy.




Primary Outcome Measures :
  1. Biochemically-verified smoking cessation [ Time Frame: 26 weeks post-quit ]
    The primary outcome measure is biochemically-verified 7-day point prevalence abstinence at 26 weeks post-quit.


Secondary Outcome Measures :
  1. Biochemically-verified smoking cessation [ Time Frame: 12 weeks post-quit ]
    The secondary outcome measure is biochemically-verified 7-day point prevalence abstinence at 12 weeks post-quit.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. are currently uninsured or receiving Medicaid benefits
  2. earn a score ≥ 4 on the REALM indicating > 6th grade English literacy level
  3. are willing to quit smoking 7 days from their first visit
  4. are ≥ 18 years of age
  5. have an expired CO level ≥ 8 ppm suggestive of current smoking
  6. are currently smoking ≥ 5 cigarettes per day
  7. are willing and able to attend 9 study visits.

Exclusion Criteria:

  1. are unwilling to quit smoking 7 days from their first visit
  2. have already quit smoking
  3. earn a score <4 on the REALM indicating < 7th grade literacy level
  4. produce an expired CO level < 8 ppm
  5. are currently smoking < 5 cigarettes per day
  6. are unwilling or unable to attend study visits
  7. are < 18 years of age
  8. are not uninsured or receiving Medicaid benefits

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): NCT02737566


Contacts
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Contact: Joseph Waring (405) 271-8001 ext 31153 joseph-waring@ouhsc.edu
Contact: Darla E. Kendzor, Ph.D. (405) 271-8001 ext 50478 Darla-Kendzor@ouhsc.edu

Locations
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United States, Oklahoma
Oklahoma Tobacco Research Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Joseph Waring    405-271-8001 ext 31153    joseph-waring@ouhsc.edu   
Contact: Darla Kendzor, Ph.D.    (405) 271-8001 ext 50478    Darla-Kendzor@ouhsc.edu   
Principal Investigator: Darla Kendzor, Ph.D.         
Sub-Investigator: Michael Businelle, Ph.D.         
Sponsors and Collaborators
University of Oklahoma
National Cancer Institute (NCI)
The University of Texas Health Science Center, Houston
William Marsh Rice University
Investigators
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Principal Investigator: Darla E. Kendzor, Ph.D. University of Oklahoma

Publications:
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT02737566     History of Changes
Other Study ID Numbers: 6260
7R01CA197314-02 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
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
Keywords provided by University of Oklahoma:
Smoking Cessation
Financial Incentives
Contingency Management
Vulnerable Populations
Medically Uninsured
Medicaid