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Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00018148
First received: July 3, 2001
Last updated: September 14, 2010
Last verified: September 2010
History of Changes
  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
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:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00018148

Locations
United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
Sponsors and Collaborators
Department of Veterans Affairs
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
Study First Received: July 3, 2001
Last Updated: September 14, 2010
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
smoking cessation

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Nortriptyline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
 Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Uptake Inhibitors
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013