Clinical trial NCT03072511: Smoking Cessation Intervention
Official title: Pilot Trial of a Smoking Cessation Intervention Informed by Construal Level Theory
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Smoking Cessation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-03-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 7-day smoking point prevalence
timeFrame: 13 weeks
measure: Delay Discounting
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Richard Yi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: