Smoking Cessation Intervention

NCT03072511 | Terminated Phase 4

• 2 other identifiers: IRB201601307 - NK02DA034767
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• 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

• Delay Discounting

  Delay Discounting Task: a binary choice procedure where two hypothetical money rewards will be presented at specified delays.

  13 weeks

Study Arms (2)

Spotlight on Smoke-Free Living

EXPERIMENTAL

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.

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

Standard Informational Treatment

ACTIVE COMPARATOR

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.

Drug: Transdermal Nicotine Patch

Interventions

Spotlight on Smoke-Free Living: Mindsets and Decisions BEHAVIORAL

Intervention will consist of elements to help quit smoking. All intervention elements will be informed by Construal Level Theory.

Also known as: SPOTLIGHT

Spotlight on Smoke-Free Living

Transdermal Nicotine Patch DRUG

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.

Also known as: TNP

Spotlight on Smoke-Free Living; Standard Informational Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Richard Yi, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 7, 2017
• Study Start: December 13, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

US (1)