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Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00018148
First Posted: July 5, 2001
Last Update Posted: September 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VA Office of Research and Development
  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 Drug: transdermal nicotine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00018148


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

Publications:
Responsible Party: Prochazka, Allan - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00018148     History of Changes
Other Study ID Numbers: ADRD-006-97F
First Submitted: July 3, 2001
First Posted: July 5, 2001
Last Update Posted: September 15, 2010
Last Verified: September 2010

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

Additional relevant MeSH terms:
Nicotine
Nortriptyline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents