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Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

NCT ID: NCT00018148

Last Updated: 2010-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-30

Study Completion Date

2003-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Transdermal nicotine plus nortriptyline

Group Type EXPERIMENTAL

nortriptyline

Intervention Type DRUG

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

2

Transdermal nicotine plus placebo

Group Type ACTIVE_COMPARATOR

transdermal nicotine

Intervention Type DRUG

Transdermal nicotine 21 mg, titrated down plus placebo

Interventions

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nortriptyline

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

Intervention Type DRUG

transdermal nicotine

Transdermal nicotine 21 mg, titrated down plus placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Department of Veterans Affairs

Principal Investigators

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Allan V. Prochazka, MD MSc

Role: PRINCIPAL_INVESTIGATOR

VA Eastern Colorado Health Care System, Denver

Locations

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VA Eastern Colorado Health Care System, Denver

Denver, Colorado, United States

Site Status

Countries

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United States

References

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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. doi: 10.1001/archinte.164.20.2229.

Reference Type RESULT
PMID: 15534159 (View on PubMed)

Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

Reference Type DERIVED
PMID: 37230961 (View on PubMed)

Other Identifiers

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ADRD-006-97F

Identifier Type: -

Identifier Source: org_study_id