Betel Quid Dependence
Conditions
Interventions
Patients attending Dental Teaching Hospital, Peradeniya with betel quid addiction will be assigned with block randomization into intervention and control groups.
Intervention group- Bupropion for bete
discontinue if person has not quit)
Control group- Placebo drug for same duration and similar frequency will be prescribed orally along with counselling. Placebo consist of the following.
Starch-110m
Sponsors
Centre for Research in Oral Cancer
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults above 18 years of age. 2. Both male and female. 3. Regular Betel Quid user – at least 1 quid per day or 7 quids per week during the last 6 months. 4. Betel quid users with at least one of the 2 ingredients in their quid; areca-nut and/or chewing tobacco. 5. Betel Quid dependent users with a Betel Quid Dependence Score (BQDS) of more than 4. 6. Able to understand the provisions of the protocol with which subject must comply and be willing to sign an informed consent. 7. Betel Quid users who are willing to quit by answering as ‘yes’ to the question ‘ Are you willing to quit your habit during the treatment phase of this trial?’ in the screening questionnaire.
Exclusion criteria
Exclusion criteria: 1. Patients with a self-reported history of seizures within the last 05 years. 2. Patients with diagnosed depression or suicidal behavior within last 01 year. 3. Patients with hepatic diseases such as cirrhosis and end stage liver failure. 4. Pregnant or nursing mothers. 5. Participants with unstable angina or a myocardial infarction within 3 months of enrollment. 6. Participants with tobacco smoking habits. 7. Patients already using an anti-psychotic or anti-depressant for other medical reasons. 8. Already undergone a pharmacological nicotine dependence treatment program within the past 03 months. 9. With a history of severe head trauma with loss of consciousness 10. With a history of an eating disorder such as anorexia nervosa or bulimia 11. Patients taking routine medication as listed below. • most antidepressants (SSRIs, many tricyclics), • beta-blockers • antiarrhythmics • antipsychotics antidepressants (e.g., nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline) • antipsychotics (e.g., haloperidol, risperidone, thioridazine) • beta-blockers (e.g., metoprolol) • Type 1C antiarrhythmics (e.g., propafenone, flecainide * MAO Inhibitors (phenelzine) * Levodopa * Amantadine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Self-reported abstinence rate at the end of treatment using a self-administered questionnaire. [09 weeks from beginning of the treatment phase AND 06 and 12 month follow-up from the end of the treatment phase [Treatment phase is for 09 weeks]] 2. Biochemically verified (using cotinine levels) abstinence rate at the end of treatment Biochemical testing of cotinine levels by urinalysis will be measured using ‘urine dip test strips’ *as cotinine will be excreted within 1 to 10 days after quitting betel quid, there should be a 100% decrease in cotinine levels prior to our urine tests. However, giving a 10% margin of error, at least a 90% decrease in cotinine levels will be expected to biochemically verify abstinence of betel quid chewing. [09 weeks from beginning of the treatment phase AND 06 and 12 month follow-up from the end of the treatment phase [Treatment phase is for 09 weeks]] [] [] [ ] [ ] [] [ ] [ ] [] [] [ ] [ ] [ ] [ ] [] [] [ ] [] [ ] [ ] [] [ ] [ ] [ ] [] [] [ ] [] [ ] [ ] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the reported adverse effects of bupropion (if any). A table with possible adverse effects will be included in an interviewer administered questionnaire. [09 weeks from beginning of the treatment phase AND 06 and 12 month follow-up from the end of the treatment phase [Treatment phase is for 09 weeks]] 2.To assess the degree and severity of withdrawal symptoms among quitters while on Bupropion A table with possible withdrawal symptoms in a 5 point Likert scale will be included in an interviewer administered questionnaire. [09 weeks from beginning of the treatment phase AND 06 and 12 month follow-up from the end of the treatment phase [Treatment phase is for 09 weeks]] 3.To assess the compliance among chewers to use a medication A yes/no question as ‘ Have you continued to quit the use of betel quid?’ will be included in an interviewer administered questionnaire followed by duration, frequency of use if the response is ‘No’. [1st review- 02 weeks from start of the treatment phase; 2nd review- 07 weeks from start of the treatment phase; 3rd review- 09 weeks from start of the treatment phase. ] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] | — |
Countries
Sri Lanka
Contacts
Public ContactProf. Ruwan Jayasinghe
Professor of Oral Medicine and Radiology
Outcome results
None listed