Efficacy and safety of bupropion in Betel Quid Addiction among patients attending Dental Teaching Hospital Peradeniya; A double-blinded, placebo-controlled trial. Betel Quid Intervention Trial (BQuIT)

Not Applicable

• Conditions: Betel Quid Dependence

• Registration Number: SLCTR/2022/020
• Lead Sponsor: Centre for Research in Oral Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified