Conditions: Nicotine Dependence
Keywords: Nicotine addiction Smoking Cessation Quit Smoking moclobemide Nicotine Patch
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 76
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.

Interventions: intervention 1: Nicotine Patch intervention 2: Moclobemide
Intervention descriptions: intervention 1: 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) intervention 2: 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)

Protocol document: