Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

US Department of Veterans Affairs (VA)

Status and phase: Completed; Phase 2

Conditions: Smoking

Treatments: Drug: nortriptyline; Drug: transdermal nicotine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00018148

ADRD-006-97F

Details and patient eligibility

About

Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco withdrawal symptoms and increases long term cessation rates when combined with transdermal nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized, parallel group trial in which smokers aged 18-70 will be subject to the combination of oral and patch treatments.

Enrollment: 158 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Aged 18-70,
• smoking > 10 cigarettes per day,
• no current major depression,
• no concurrent psychiatric medications

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 2 patient groups

1

Experimental group

Description:

Transdermal nicotine plus nortriptyline

Treatment:

Drug: nortriptyline

2

Active Comparator group

Description:

Transdermal nicotine plus placebo

Treatment:

Drug: transdermal nicotine