Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

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.

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Nortriptyline

Drug

Dose titrated to 75 mg daily as tolerated combined with transdermal nicotine 21 mg

Transdermal Nicotine

Drug

Transdermal nicotine 21 mg, titrated down plus placebo

Primary outcomes

Validated smoking cessation

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start: 1998
Primary completion: 2002
Study completion: 2003
First posted: Jul 5, 2001
Registry last updated: Sep 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed