Smoking Cessation Intervention

Smoking Cessation Clinical Trial

— SPOTLIGHT  

Official title:

Pilot Trial of a Smoking Cessation Intervention Informed by Construal Level Theory

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03072511
• Other study ID #: IRB201601307 - N
• Secondary ID: K02DA034767
• Status: Terminated
• Phase: Phase 4
• Start date: December 13, 2016
• Est. completion date: August 1, 2018

Study information

• Verified date: January 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day smoking point prevalence	Timeline Follow-Back: assesses smoking patterns through daily logs of smoking tendencies, use of nicotine patches, and attempts to quit.	13 weeks
Primary	Delay Discounting	Delay Discounting Task: a binary choice procedure where two hypothetical money rewards will be presented at specified delays.	13 weeks