A Comparative Effectiveness RCT of Optimized Cessation Treatments

Completed · Phase 4

Conditions studied: Smoking Cessation

In brief

This study is a 2-arm randomized clinical trial (RCT). Participants motivated to quit smoking will be randomized to one of two treatments: 1) a Modern Usual Care (M-UC) vs. 2) Abstinence-Optimized Cessation Treatment (AOCT). The components for the optimized treatment have strong theoretical and empirical support from the investigators previous screening studies.

Key facts

Study ID

NCT02301403

Run by

University of Wisconsin, Madison

People needed

623

Starts

2015-01-01

Expected to finish

2018-02-01

Last updated by the study team

2020-05-13

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)
• not currently attempting to quit smoking
• not intending to quit smoking (defined as no plans to quit in the next month)
• and planning to remain in the intervention catchment area for at least 12 months.

You may not qualify if…

• currently taking bupropion or 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 30 days
• 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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