Topiramate for tobacco dependence
| ISRCTN | ISRCTN93532081 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93532081 |
| Secondary identifying numbers | PI061462 |
- 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
Scientific
Avda. Gomez Laguna 52, 4 D
Zaragoza
50009
Spain
| Phone | +34 97 651 10 12 |
|---|---|
| martaalda@hotmail.com |
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Topiramate, nicotine |
| Primary outcome measure | 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 study start date | 01/04/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 patients (75 patients in each branch of treatment) |
| 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
50009
Spain
Sponsor information
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Research organisation
Research organisation
Calle Sinesio Delgado
Nº 6 (pabellón número 4)
Madrid
28029
Spain
| Phone | +34 91 822 21 00 |
|---|---|
| Oficina.informacion@isciii.es | |
| Website | http://www.isciii.es |
"ROR" |
https://ror.org/00ca2c886 |
Funders
Funder type
Government
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
31/05/2019: Publication reference and total final enrolment added.
