Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00018148

Enrollment

158

Registered

2001-07-05

Start date

1998-04-30

Completion date

2003-01-31

Last updated

2010-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

Keywords

smoking cessation

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.

Interventions

DRUGnortriptyline

Dose titrated to 75 mg daily as tolerated combined with transdermal nicotine 21 mg

DRUGtransdermal nicotine

Transdermal nicotine 21 mg, titrated down plus placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Validated smoking cessation	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026