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Smoking Cessation Intervention (SPOTLIGHT)

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ClinicalTrials.gov Identifier: NCT03072511
Recruitment Status : Suspended (PI is relocating to another institution.)
First Posted : March 7, 2017
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE March 1, 2017
First Posted Date  ICMJE March 7, 2017
Last Update Posted Date January 17, 2019
Actual Study Start Date  ICMJE December 13, 2016
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • 7-day smoking point prevalence [ Time Frame: 13 weeks ]
    Timeline Follow-Back: assesses smoking patterns through daily logs of smoking tendencies, use of nicotine patches, and attempts to quit.
  • Delay Discounting [ Time Frame: 13 weeks ]
    Delay Discounting Task: a binary choice procedure where two hypothetical money rewards will be presented at specified delays.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03072511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smoking Cessation Intervention
Official Title  ICMJE Pilot Trial of a Smoking Cessation Intervention Informed by Construal Level Theory
Brief Summary Cigarette smoking is the leading cause of preventable mortality in the United States, yet less than 10% of smokers making a serious quit attempt remain abstinent from cigarettes 1 year later, and outcomes from gold-standard behavioral interventions leave much room for improvement. As such, in the context of a Stage-I randomized controlled trial (RCT), this study will examine (1) treatment characteristics and delivery, treatment integrity, dropout, and acceptability, (2) smoking outcomes such as lapse, relapse, and abstinence measures, and (3) changes decision-making that result from a novel intervention informed by behavioral analysis and social cognition.
Detailed Description Cigarette smoking is the leading cause of preventable mortality in the United States, implicated in countless health consequences, and significant economic and societal costs. Less than 10% of smokers making a serious quit attempt remain abstinent from cigarettes 1 year later, and outcomes from gold-standard behavioral interventions leave much room for improvement. Thus the development of new interventions and improvements to existing interventions is imperative. Behavioral interventions for smoking cessation have insufficiently integrated the findings from basic research on decision-making processes. Thus, there is extensive laboratory-based research indicating the potential for laboratory-based manipulations that affect decision making relevant for smoking, the examination of a coherent intervention that capitalizes on this knowledge is limited. The proposed research is the first step toward synthesizing insights from the research domains of addiction, behavioral analysis, and social cognition into a cohesive formulation with potential impact on smoking cessation. Specifically, the research targets impulsive decision making associated with cigarette smoking and relapse by incorporating the influential Construal Level Theory.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Behavioral: Spotlight on Smoke-Free Living: Mindsets and Decisions
    Intervention will consist of elements to help quit smoking. All intervention elements will be informed by Construal Level Theory.
    Other Name: SPOTLIGHT
  • Drug: Transdermal Nicotine Patch
    TNP serve as nicotine replacement for individuals who are attempting to stop smoking. They are safe for use and dosing will be determined for each participant based off of manufacturer's recommendations.
    Other Name: TNP
Study Arms  ICMJE
  • Experimental: Spotlight on Smoke-Free Living
    Treatment will include a 1.5-hour intervention session combined with daily text-messaging for up to 1 week pre-quit and 4 weeks post-quit. The intervention includes: mindful breathing, visualization, and identification and thinking about goals and priorities inconsistent with smoking. During the text-messaging phase, elements of the intervention discussed during the in-person session will be reinforced. Participants will be provided transdermal nicotine patches (TNP). TNP are a safe and effective approach to nicotine replacement when an individual attempts to stop smoking and are safe for use without prescription. Participants will begin the regimen on the scheduled quit date with an initial dose of 21 mg (4 weeks), followed by 14 mg (2 weeks), and 7 mg (2 weeks). Alterations to dosing will be allowed when appropriate and consistent with manufacturer's recommendations. While TNP will be offered to all participants, they can decline or discontinue use of TNP at any time.
    Interventions:
    • Behavioral: Spotlight on Smoke-Free Living: Mindsets and Decisions
    • Drug: Transdermal Nicotine Patch
  • Active Comparator: Standard Informational Treatment
    Standard informational treatment is based on conventional, information-based smoking cessation approaches commonly found in public health settings. This will include the following information: prevalence/incidence of cigarette smoking and negative health outcomes associated with cigarette smoking (e.g., cancer, respiratory disease, complications), other health consequences resulting from diseases associated with cigarette smoking, personal/financial/social consequences of cigarette smoking. During the text-messaging phase, information about the consequences of smoking discussed during the in-person session will be reiterated. As with the experimental condition, participants will be provided with 8-weeks TNP.
    Intervention: Drug: Transdermal Nicotine Patch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Actual Enrollment  ICMJE
 (submitted: August 10, 2018)
23
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2017)
180
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Current cigarette smoker (verified with an expired carbon monoxide level of at least 4 ppm of expired air),
  • At least 18 years of age,
  • With a desire to quit smoking in the next month (at least 5 on a 10-point scale).

Exclusion Criteria:

  • Pregnancy,
  • Having uncontrolled serious psychiatric or medical illnesses,
  • Having recent suicide attempts or ideation,
  • Meeting contraindications for use of nicotine replacement products,
  • Taking pharmocotherapy for smoking cessation treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03072511
Other Study ID Numbers  ICMJE IRB201601307 - N
K02DA034767 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Richard Yi, Ph.D. University of Florida
PRS Account University of Florida
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP