Smoking Cessation Intervention (SPOTLIGHT)

University of Florida

Status and phase: Terminated; Phase 4

Conditions: Smoking Cessation

Treatments: Drug: Transdermal Nicotine Patch; Behavioral: Spotlight on Smoke-Free Living: Mindsets and Decisions

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03072511

IRB201601307 - N

K02DA034767 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups

Spotlight on Smoke-Free Living

Experimental group

Description:

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.

Treatment:

Behavioral: Spotlight on Smoke-Free Living: Mindsets and Decisions

Drug: Transdermal Nicotine Patch

Standard Informational Treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Transdermal Nicotine Patch