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Randomized Clinical Trial to Reduce Harm From Tobacco

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ClinicalTrials.gov Identifier: NCT02328794
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Vitality Institute
Information provided by (Responsible Party):
Scott Halpern, University of Pennsylvania

Brief Summary:
Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to determine the effectiveness of 4 different interventions aimed at smoking cessation, two of which are incentive structures that are each grounded in behavioral economic principles. The other interventions will determine the effectiveness of various cessation aids, including electronic cigarettes and text messaging, on smoking cessation. This study will be conducted as an opt-out procedure where participants are automatically enrolled in the program but have the choice to unenroll if they so chose. This pragmatic approach will allow us to investigate the effects of such programs in an employee based population that can be easily mimicked in other employee based populations.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: E-cigarette free access Behavioral: E-cigarette/NRT/Zyban/Chantix Choice Behavioral: Outcome Incentive arm Behavioral: Loss framing incentive arm Behavioral: Control Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6006 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial to Reduce Harm From Tobacco
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : November 5, 2016
Actual Study Completion Date : April 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking

Arm Intervention/treatment
Active Comparator: Control
Participants randomized to this arm will receive a standardized Vitality program aimed at promoting tobacco cessation. This program includes existing employee benefits for quitting and the use of text/email messages to encourage tobacco cessation. No incentives will be given to participants randomized to this arm. Free cessation aids will not be available to participants in this arm. They will receive compensation for completing study related activities (sample submissions).
Behavioral: Control
Participants will have access to information and advice on quitting smoking. This is a control and no actual intervention will be applied.

Experimental: E-cigarette free access
Participants randomized to this experimental arm will receive the standardized program including text/email messaging and will have access to free e-cigarettes only. These products can be ordered directly, free of charge, through the web-based interface. No incentives will be given to participants randomized to this arm. They will receive compensation for completing study related activities (sample submissions).
Behavioral: E-cigarette free access
Participants in this arn will be given free access to e-cigarettes to help quit smoking

Experimental: E-cigarette/NRT/Zyban/Chantix Choice
Participants randomized to this experimental arm will receive the standardized program including text/email messaging and will have access to free e-cigarettes, conventional Nicotine Replacement Therapy (NRT), Zyban, or Chantix. Each of these can be ordered directly, free of charge, through the web-based interface. No incentives will be given to participants randomized to this arm. They will receive compensation for completing study related activities (sample submissions).
Behavioral: E-cigarette/NRT/Zyban/Chantix Choice
Participants in this arn will be given free access to cessation aids to help quit smoking

Experimental: Outcome Incentive arm
Participants randomized to this experimental arm will receive the standardized program and access to free e-cigarettes, NRT, Zyban, or Chantix. In addition, they will also be able to earn incentives across six months for testing negative for tobacco use (see Incentive payout, below). They will also receive compensation for completing study related activities (sample submissions).
Behavioral: Outcome Incentive arm
Participants in this arm will be earn incentives across 6 months for verified abstinence.

Experimental: Loss framing incentive arm
Participants randomized to this experimental arm will receive the standardized program and access to free e-cigarettes, NRT, Zyban, or Chantix. In addition they will also be able to earnincentives across six months through a pre-funded deposit or precommitment account. They will be notified that money has been placed into an account for them. At each time point they will lose a portion (see below) of this initial funding if they do not provide biochemical evidence of abstinence. They will also receive compensation for completing study related activities (sample submissions).
Behavioral: Loss framing incentive arm
Participants in this arm will be told they have a pre-funded account with money that is theirs if they quit smoking.




Primary Outcome Measures :
  1. verified abstinence 6 months [ Time Frame: 6 months ]
    Biometric testing (metabolites of nicotine) at 6 months following the quit date


Secondary Outcome Measures :
  1. verified abstinence 1 months [ Time Frame: 12 months ]
    Biometric testing (metabolites of nicotine) at 1 month, 3 months, and 12 months following the quit date.

  2. verified abstinence 3 months [ Time Frame: 12 months ]
    Biometric testing (metabolites of nicotine) at 1 month, 3 months, and 12 months following the quit date.

  3. verified abstinence 12 months [ Time Frame: 12 months ]
    Biometric testing (metabolites of nicotine) at 1 month, 3 months, and 12 months following the quit date.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Vitality beneficiary
  • 18 years or older
  • reported and/or tested positive for being a smoker
  • all participants will be able to opt-out of this program.

Exclusion Criteria:

  • Participants who express wanting to opt-out of this program will be un-enrolled and excluded

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): NCT02328794


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Vitality Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scott Halpern, Assistant Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02328794     History of Changes
Other Study ID Numbers: 820451
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017

Keywords provided by Scott Halpern, University of Pennsylvania:
smoking cessation
behavioral economics
e-cigarettes
NRT

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs