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Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT00018148
Recruitment Status : Completed
First Posted : July 5, 2001
Last Update Posted : September 15, 2010
Sponsor:
Information provided by:
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Smoking Drug: nortriptyline Drug: transdermal nicotine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
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
Study Start Date : April 1998
Actual Primary Completion Date : December 2002
Actual Study Completion Date : January 2003

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Validated smoking cessation [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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:


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

Publications of Results:
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 Posted: July 5, 2001    Key Record Dates
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