Topiramate for tobacco dependence

Effectiveness of topiramate for tobacco dependence in patients with depression: a randomised, controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN93532081

Enrollment

150

Registered

2008-02-27

Start date

2008-04-01

Completion date

Unknown

Last updated

2019-06-26

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

Conditions

Tobacco dependence, major depressive disorder Mental and Behavioural Disorders Tobacco dependence

Interventions

A multi-component programme for tobacco cessation will be offered to all patients in the study. This is made up of pharmacological therapy and group cognitive-behavioural therapy. The group is made up

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 - 65 years, either sex 2. Able to understand and read Spanish 3. Fulfill criteria for major depression (Diagnostic and Statistical Manual of Mental Disorders, 4th edition [DSM-IV] criteria) 4. Scores on the Zung Self-Rating Depression Scale less than 60 (implying minimal to mild depression) 5. Smoke more than 20 cigarettes/day 6. Fulfil preparation state of change according to Prochaska and DiClemente classification 7. Voluntarily ask for a tobacco cessation therapy 8. Sign informed consent

Exclusion criteria

Exclusion criteria: 1. Active psychosis and/or treatment with antipsychotic drugs 2. Alcohol or drug abuse 3. Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
The major outcome is tobacco cessation in patients with depression. The diagnosis of tobacco dependence will be made with the Spanish version of the Mini-International Neuropsychiatric Interview (MINI), substance dependence module adapted to tobacco (measured at baseline and at the end of study [month 12]). Tobacco abstinence will also be diagnosed by: 1. Self-declared abstinence 2. Self-administered Minnesota tobacco abstinence symptoms, measured at baseline, D (cessation day) -1, weeks 1, 2, 3, 4, 8, 12, and months 4, 5, 6, 8, 10 and 12 3. Expired air carbon monoxide, measured at baseline, D (cessation day) -1, weeks 1, 2, 3, 4, 8, 12, and months 4, 5, 6, 8, 10 and 12 4. Cotinine in saliva, measured at baseline, D (cessation day) -1, weeks 1, 2, 3, 4, 8, 12, and months 4, 5, 6, 8, 10 and 12	—

Measure

Time frame

The major outcome is tobacco cessation in patients with depression. The diagnosis of tobacco dependence will be made with the Spanish version of the Mini-International Neuropsychiatric Interview (MINI), substance dependence module adapted to tobacco (measured at baseline and at the end of study [month 12]). Tobacco abstinence will also be diagnosed by: 1. Self-declared abstinence 2. Self-administered Minnesota tobacco abstinence symptoms, measured at baseline, D (cessation day) -1, weeks 1, 2, 3, 4, 8, 12, and months 4, 5, 6, 8, 10 and 12 3. Expired air carbon monoxide, measured at baseline, D (cessation day) -1, weeks 1, 2, 3, 4, 8, 12, and months 4, 5, 6, 8, 10 and 12 4. Cotinine in saliva, measured at baseline, D (cessation day) -1, weeks 1, 2, 3, 4, 8, 12, and months 4, 5, 6, 8, 10 and 12

—

Secondary

Measure	Time frame
The diagnosis of depressive disorder will be made with the Spanish version of the MINI psychiatric interview, depression module, and the severity of the depression with the Spanish version of the Zung Self-Rating Depression Scale (measured at baseline and at the end of study [month 12]). In addition, the following will be also recorded: 1. Tobacco dependence as measured by the Spanish version of the Fagerström test for Nicotine Dependence, measured at baseline, D (cessation day) -1, weeks 1, 2, 3, 4, 8, 12, and months 4, 5, 6, 8, 10 and 12 2. Anxiety trait and state as measured by the Spanish version of the State-Trait Anxiety Inventory (STAI), measured at baseline, D (cessation day) -1, weeks 1, 2, 3, 4, 8, 12, and months 4, 5, 6, 8, 10 and 12 3. Impulsivity as measured by the Spanish version of the Plutchik scale of impulsivity, measured at baseline, D (cessation day) -1, weeks 1, 2, 3, 4, 8, 12, and months 4, 5, 6, 8, 10 and 12 4. Visual analogue scale for efficacy self-perception, measured at baseline, D (cessation day) -1, weeks 1, 2, 3, 4, 8, 12, and months 4, 5, 6, 8, 10 and 12 5. Pharmacological side-effects	—

Measure

Time frame

The diagnosis of depressive disorder will be made with the Spanish version of the MINI psychiatric interview, depression module, and the severity of the depression with the Spanish version of the Zung Self-Rating Depression Scale (measured at baseline and at the end of study [month 12]). In addition, the following will be also recorded: 1. Tobacco dependence as measured by the Spanish version of the Fagerström test for Nicotine Dependence, measured at baseline, D (cessation day) -1, weeks 1, 2, 3, 4, 8, 12, and months 4, 5, 6, 8, 10 and 12 2. Anxiety trait and state as measured by the Spanish version of the State-Trait Anxiety Inventory (STAI), measured at baseline, D (cessation day) -1, weeks 1, 2, 3, 4, 8, 12, and months 4, 5, 6, 8, 10 and 12 3. Impulsivity as measured by the Spanish version of the Plutchik scale of impulsivity, measured at baseline, D (cessation day) -1, weeks 1, 2, 3, 4, 8, 12, and months 4, 5, 6, 8, 10 and 12 4. Visual analogue scale for efficacy self-perception, measured at baseline, D (cessation day) -1, weeks 1, 2, 3, 4, 8, 12, and months 4, 5, 6, 8, 10 and 12 5. Pharmacological side-effects

—

Countries

Spain

Outcome results

None listed

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