Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

This study has been completed.

First Received: July 3, 2001 Last Updated: January 20, 2009 History of Changes

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00018148

Purpose

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.

Condition	Intervention	Phase
Smoking	Drug: nortriptyline	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nortriptyline Nortriptyline hydrochloride

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Study Start Date:	April 1998
Estimated Study Completion Date:	March 2001

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018148

Locations

United States, Colorado
VAMC
Denver, Colorado, United States, 80220

Sponsors and Collaborators

Department of Veterans Affairs

More Information

No publications provided

Study ID Numbers:	ADRD-006-97F
Study First Received:	July 3, 2001
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00018148 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

smoking cessation

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Neurotransmitter Agents
Adrenergic Agents
Nicotine

Nortriptyline
Psychotropic Drugs
Antidepressive Agents
Antidepressive Agents, Tricyclic

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions

Antidepressive Agents, Tricyclic
Smoking
Habits
Therapeutic Uses
Nortriptyline
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 04, 2009