Topiramate for tobacco dependence

ISRCTN	ISRCTN93532081
DOI	https://doi.org/10.1186/ISRCTN93532081
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	PI061462
Sponsor	The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Funder	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)

Submission date: 30/01/2008
Registration date: 27/02/2008
Last edited: 31/05/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marta Alda
Scientific

Avda. Gomez Laguna 52, 4 D
Zaragoza
50009
Spain

Phone	+34 97 651 10 12
Email	martaalda@hotmail.com

Study information

Primary study design	Interventional
Study design	This is a controlled trial with a random allocation of patients into control group (NST) or intervention group (topiramate)
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effectiveness of topiramate for tobacco dependence in patients with depression: a randomised, controlled trial
Study acronym	N/A
Study objectives	Topiramate is at least as effective like nicotine substitution therapy (NST - the standard treatment) for tobacco dependence.
Ethics approval(s)	Ethics approval received from the Ethical Review Board of the Regional Health Authority of Aragon (Spain) in February 2007 (ref: FIS PI06/1462).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Topiramate, nicotine
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Total final enrolment	180
Key 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
Key exclusion criteria	1. Active psychosis and/or treatment with antipsychotic drugs 2. Alcohol or drug abuse 3. Pregnancy or lactation
Date of first enrolment	01/04/2008
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Spain

Study participating centre

Avda. Gomez Laguna 52, 4 D

Zaragoza
50009
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/05/2008	31/05/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

31/05/2019: Publication reference and total final enrolment added.