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Smoking Cessation Intervention

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03072511
Acronym
SPOTLIGHT
Enrollment
23
Registered
2017-03-07
Start date
2016-12-13
Completion date
2018-08-01
Last updated
2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

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.

Interventions

BEHAVIORALSpotlight 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.

DRUGTransdermal 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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
7-day smoking point prevalence13 weeksTimeline Follow-Back: assesses smoking patterns through daily logs of smoking tendencies, use of nicotine patches, and attempts to quit.
Delay Discounting13 weeksDelay Discounting Task: a binary choice procedure where two hypothetical money rewards will be presented at specified delays.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026