A pragmatic randomised controlled trial to test the efficacy of nortriptyline plus nicotine replacement therapy (NRT) versus a placebo plus NRT in helping smokers to stop and testing the role of noradrenergic and dopaminergic genetic variants in smoking cessation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57852484

Enrollment

900

Registered

2005-07-25

Start date

2003-08-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Smoking cessation Mental and Behavioural Disorders Smoking cessation

Interventions

NRT plus nortriptyline/placebo.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Smoked at least 10 cigarettes per day on average over the past year. 2. Want to quit 3. Prepared to use NRT and the trial drug 4. Using an NHS stop smoking service

Exclusion criteria

Exclusion criteria: 1. Pregnant or breast feeding or planning to do so in the next 3 months 2. Not clinically suitable to use NRT according to data sheet 3. Not clinically suitable to use nortriptyline according to data sheet

Design outcomes

Primary

Measure	Time frame
Six months of continuous abstinence biochemically confirmed.	—

Secondary

Measure	Time frame
1. Seven-day point prevalence 2. Twelve-month continuous abstinence	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 5, 2026