Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

Phase 2

Completed

• Conditions: Smoking
• Interventions: Drug: transdermal nicotine; Drug: nortriptyline

• Registration Number: NCT00018148
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-04
• Study First Submitted: 2001-07-03
• Study First Submitted QC: 2001-07-04
• Study First Posted: 2001-07-05
• Primary Completion: 2002-12
• Study Completion: 2003-01
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-14
• Last Update Posted: 2010-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	transdermal nicotine	Transdermal nicotine plus placebo
1	nortriptyline	Transdermal nicotine plus nortriptyline

Primary Outcome Measures

Name	Time	Method
Validated smoking cessation	6 months

Trial Locations

Locations (1)

VA Eastern Colorado Health Care System, Denver; 🇺🇸 Denver, Colorado, United States