NCT01926626

Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Jed E. Rose · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The proposed study will assess the efficacy of moclobemide, a selective, reversible MAO-A inhibitor, in facilitating smoking cessation in treatment-seeking female smokers. This rationale is based on several findings from previous work: 1) cigarette smoke contains constituents that inhibit both forms of the enzyme monoamine oxidase (MAO-A and MAO-B); 2) that severity of depression symptoms after smoking abstinence is correlated with the level of MAO-A inhibition previously obtained from smoking; 3) moclobemide, an MAO-A inhibitor was found efficacious in a smoking cessation treatment trial (Berlin et al., 1995); and 4) women show a greater association between smoking and depression than men and women smokers in our previous trials report smoking to alleviate symptoms of depression to a greater extent than men.

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	Nicotine Patch	Pre-Quit Period: 2 weeks of patch use (21mg/24hr) Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
DRUG	Moclobemide	Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses) Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-07-01
• Completion: 2014-10-01
• First posted: 2013-08-21
• Last updated: 2017-08-23
• Results posted: 2015-07-29

Locations

3 sites across 1 country: United States