MedTrace Logo

Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

NCT00018148 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2010-09-15

No results posted yet for this study

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.

Conditions

  • Smoking

Interventions

DRUG

nortriptyline

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

DRUG

transdermal nicotine

Transdermal nicotine 21 mg, titrated down plus placebo

Sponsors & Collaborators

Principal Investigators

  • Allan V. Prochazka, MD MSc · VA Eastern Colorado Health Care System, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-04-30
Primary Completion
2002-12-31
Completion
2003-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00018148 on ClinicalTrials.gov