The Long-Term Quitting (Smoking Cessation) Study

Completed · Phase 4

Conditions studied: Smoking Cessation

In brief

Relapse after a serious quit attempt occurs in 70-90% of smokers who try to quit smoking. This study utilizes a sequential, multiple assignment, randomized trial (SMART) design - - an innovative multi-phase approach - - to test post-relapse treatments designed to assist smokers to make a new, successful quit attempt. This study will test Relapse Recovery (RR) treatments that are applied at two stages following relapse: 1) RR Preparation Phase treatments for smokers who relapse after an initial quit attempt, and 2) RR Cessation Phase treatments for relapsed smokers who decide to make a new quit attempt. Smokers motivated to quit smoking will make an initial quit attempt in the Quit Phase (cessation medication + counseling). Participants who relapse will be randomized to one of three RR Preparation Phase treatments (Behavioral \[Smoking\] Reduction Counseling + the Nicotine Mini-Lozenge; Recycling Counseling that encourages participants to quit again as soon as possible; and Preparation Phase Control). RR Preparation Phase participants (other than controls) who elect to try a new quit attempt will be randomized to one of four RR Cessation Phase treatments based on a 2X2 fully-crossed factorial design testing two factors: Supportive Counseling (vs. Brief Information) and Skill Training (vs. Brief Information). All RR Cessation Phase participants will receive 8 weeks of combination nicotine replacement therapy (nicotine patch + nicotine mini-lozenge). The investigators hypothesize that RR Preparation Phase Reduction treatment will significantly increase long-term abstinence rates relative to the Preparation Phase Control condition.

Key facts

Study ID

NCT02564315

Run by

University of Wisconsin, Madison

People needed

1154

Starts

2015-10-30

Expected to finish

2019-11-05

Last updated by the study team

2020-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age >=18 years,
• smoking >4 cigarettes/day for the previous 6 months,
• able to read, write, and speak English,
• have reliable phone access and agree to respond to Interactive Voice Response (IVR) phone prompts, and
• if currently using NRT, agreeing to use only study medication for the duration of the study, we will not exclude participants based on their prior use of cessation medication or if they use multiple tobacco products in order to enhance real-world generalization (these will be statistically controlled in analyses),
• motivation to quit smoking, and
• planning to remain in the intervention catchment area for at least 2 years and 2 months, .

You may not qualify if…

• Currently taking bupropion or varenicline,
• unwillingness to cease other forms of nicotine replacement or Chantix (also called Varenicline),
• medical contraindications to using NRT including hospitalized (for at least one night) for a stroke, heart attack, congestive heart failure or diabetes in the last 4 weeks, history of a serious skin or allergic reaction to using the Nicotine patch,
• diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years and,
• if the participant is a woman of childbearing potential, being pregnant or intending to becoming pregnant or unwillingness to use an approved method of birth control during treatment.

Where it is running

• University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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