NCT00018148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 1998

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2001

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
Last Updated

September 15, 2010

Status Verified

September 1, 2010

Enrollment Period

4.7 years

First QC Date

July 3, 2001

Last Update Submit

September 14, 2010

Conditions

Smoking

Keywords

smoking cessation

Outcome Measures

Primary Outcomes (1)

  • Validated smoking cessation

    6 months

Study Arms (2)

1

EXPERIMENTAL

Transdermal nicotine plus nortriptyline

Drug: nortriptyline

2

ACTIVE COMPARATOR

Transdermal nicotine plus placebo

Drug: transdermal nicotine

Interventions

nortriptylineDRUG

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

1
transdermal nicotineDRUG

Transdermal nicotine 21 mg, titrated down plus placebo

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

Location

Related Publications (2)

  • 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.

    PMID: 15534159RESULT

  • 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.

    PMID: 37230961DERIVED

MeSH Terms

Conditions

SmokingSmoking Cessation

Interventions

NortriptylineTobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

DibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsTherapeutics

Study Officials

  • Allan V. Prochazka, MD MSc

    VA Eastern Colorado Health Care System, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

July 3, 2001

First Posted

July 5, 2001

Study Start

April 1, 1998

Primary Completion

December 1, 2002

Study Completion

January 1, 2003

Last Updated

September 15, 2010

Record last verified: 2010-09

Locations

US(1)