Trial intelligence / Profile preview

Varenicline and ACT for Smoking Cessation in Serious Mental Illness

NCT04011280Phase 4

Key facts

Status
Completed
Start
Aug 2019
Primary completion
Mar 2022
Countries
1
Sponsor
University of California, San Diego
Modality
Small Molecules
Conditions
nicotine dependence
01

Overview

Phase 4, randomised, double-blind trial of varenicline in nicotine dependence (2 arms), sponsored by University of California, San Diego. Primary endpoint: Feasibility of Combining ACT With 2 Different Varenicline-assisted Quitting Strategies at 24 weeks. Started Aug 2019; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Low Dose Varenicline

    0.5 mg twice daily with slower titration

  • Standard Dose Varenicline

    1.0 mg twice daily with standard titration

03

Who it enrols

Smokers with bipolar disorder or schizophrenia spectrum disorder motivated to quit.

04

Endpoints

Primary

  • Feasibility of Combining ACT With 2 Different Varenicline-assisted Quitting Strategies

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