Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

This study has been completed.
Information provided by:
VA Office of Research and Development Identifier:
First received: July 3, 2001
Last updated: September 14, 2010
Last verified: September 2010
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
Drug: nortriptyline
Drug: transdermal nicotine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Validated smoking cessation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 158
Study Start Date: April 1998
Study Completion Date: January 2003
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Transdermal nicotine plus nortriptyline
Drug: nortriptyline
Dose titrated to 75 mg daily as tolerated combined with transdermal nicotine 21 mg
Active Comparator: 2
Transdermal nicotine plus placebo
Drug: transdermal nicotine
Transdermal nicotine 21 mg, titrated down plus placebo


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

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00018148

United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Allan V. Prochazka, MD MSc VA Eastern Colorado Health Care System, Denver
  More Information

Responsible Party: Prochazka, Allan - Principal Investigator, Department of Veterans Affairs Identifier: NCT00018148     History of Changes
Other Study ID Numbers: ADRD-006-97F 
Study First Received: July 3, 2001
Last Updated: September 14, 2010
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
smoking cessation

Additional relevant MeSH terms:
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Antidepressive Agents, Tricyclic
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses processed this record on February 07, 2016