drugset / Trial / NCT00770666
Combination Medications vs. Patch Alone for Medically-Ill Smokers
Phase 4
Completed
127 enrolled
University of Medicine and Dentistry of New Jersey
Robert Wood Johnson Foundation · collabRutgers Cancer Institute of New Jersey · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness
Timeline
- Start
- 2005-09
- Primary completion
- 2007-12
- Completion
- 2008-01
Outcome
Met primary endpoint
paper Abstinence rates at 26 weeks were 35% (22 of 63 patients) for the combination group versus 19% (12 of 64 patients) for the patch-alone group PMID 19349630 ↗
paper relapse benefit, 16% [95% CI, 1% to 31%]; P = 0.040). PMID 19349630 ↗
Publications
- Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
- Steinberg MB, Greenhaus S, Schmelzer AC, Bover MT, Foulds J, Hoover DR, Carson JL. Triple-combination pharmacotherapy for medically ill smokers: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):447-54. doi: 10.7326/0003-4819-150-7-200904070-00004.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupropion | Small molecule | 150 mg | — |
| Subject | Nicotine | Unknown | 21 mg | Inhaled |
Indications
No indication recorded.