Condition category
Mental and Behavioural Disorders
Date applied
30/01/2008
Date assigned
27/02/2008
Last edited
27/02/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marta Alda

ORCID ID

Contact details

Avda. Gomez Laguna 52
4 D
Zaragoza
50009
Spain
+34 97 651 10 12
martaalda@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI061462

Study information

Scientific title

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

Acronym

Study hypothesis

Topiramate is at least as effective like nicotine substitution therapy (NST - the standard treatment) for tobacco dependence.

Ethics approval

Ethics approval received from the Ethical Review Board of the Regional Health Authority of Aragon (Spain) in February 2007 (ref: FIS PI06/1462).

Study design

This is a controlled trial with a random allocation of patients into control group (NST) or intervention group (topiramate)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Tobacco dependence, major depressive disorder

Intervention

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 of 7 - 12 patients with depression and tobacco dependence, and is led by two therapists (a psychologist and a family doctor) trained in group therapy and tobacco cessation. Each session lasts 90 minutes, and the structure of every session and the contents are manualised and based on the standard programmes of this type.

Pharmacological therapy consists of:
1. Control group: Nicotine Substitution Therapy (nicotine patches) at doses of 21 mg/day first and second fortnight, 14 mg/day third fortnight and 7 mg/day fourth and last fortnight
2. Intervention group: Topiramate (oral) 100 - 200 mg/day, during 2 months

The follow-up of the treatments and adverse effects will be made at the appointmets described (during the first two months of the intervention).

Intervention type

Drug

Phase

Not Specified

Drug names

Topiramate, nicotine

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/04/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150 patients (75 patients in each branch of treatment)

Participant exclusion criteria

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

Recruitment start date

01/04/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Spain

Trial participating centre

Avda. Gomez Laguna 52, 4 D
Zaragoza
50009
Spain

Sponsor information

Organisation

The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)

Sponsor details

Calle Sinesio Delgado
Nº 6 (pabellón número 4)
Madrid
28029
Spain
+34 91 822 21 00
Oficina.informacion@isciii.es

Sponsor type

Research organisation

Website

http://www.isciii.es

Funders

Funder type

Government

Funder name

Carlos III Health Institute of the Spanish Ministry of Health and Consumption (Fondo de Investigaciones Sanitarias - Instituto de Salud Carlos III-Ministerio de Sanidad y Consumo) (Spain) (ref: PI06/1462)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes