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NCT00018148 Clinical Trial

Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

Smoking Clinical Trial

Official title:
Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00018148
Other study ID # ADRD-006-97F
Secondary ID
Status Completed
Phase Phase 2
First received July 3, 2001
Last updated September 14, 2010
Start date April 1998
Est. completion date January 2003

Study information
Verified date September 2010
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 158
Est. completion date January 2003
Est. primary completion date December 2002
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Aged 18-70,

- smoking > 10 cigarettes per day,

- no current major depression,

- no concurrent psychiatric medications

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• nortriptyline
Dose titrated to 75 mg daily as tolerated combined with transdermal nicotine 21 mg
• transdermal nicotine
Transdermal nicotine 21 mg, titrated down plus placebo

Locations
Country Name City State
United States VA Eastern Colorado Health Care System, Denver Denver Colorado

Sponsors (1)
Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Prochazka AV, Kick S, Steinbrunn C, Miyoshi T, Fryer GE. A randomized trial of nortriptyline combined with transdermal nicotine for smoking cessation. Arch Intern Med. 2004 Nov 8;164(20):2229-33. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Validated smoking cessation 6 months No
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