Home » Trials » SLCTR/2022/020


Efficacy of bupropion in the Pharmacological Management of Betel Quid Addiction.

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SLCTR Registration Number

SLCTR/2022/020


Date of Registration

02 Sep 2022

The date of last modification

Sep 02, 2022



Application Summary


Scientific Title of Trial

Efficacy of bupropion in the Pharmacological Management of Betel Quid Addiction.


Public Title of Trial

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)


Disease or Health Condition(s) Studied

Betel Quid Dependence


Scientific Acronym

BQuIT


Public Acronym

BQuIT


Brief title

Betel Quid Intervention Trial


Universal Trial Number

U1111-1279-6984


Any other number(s) assigned to the trial and issuing authority

2021/EC/50; FoM, University of Peradeniya


Trial Details


What is the research question being addressed?

What is the efficacy of the use of bupropion an anti-depressant as pharmacological management for the addiction of betel quid in comparison to a placebo controlled group?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded : Participants, Outcome assessors


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Study Phase

Not Applicable


Intervention(s) planned

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 betel quid addiction in which bupropion will be prescribed orally as shown below along with counselling. Day 1- 6 - 150 mg bupropion once a day (morning is best) Day 7–49 - 150 mg bupropion twice a day (with an interval of at least 8 hours between doses) Day 50–63 150 mg bupropion twice a day (if the person has stopped the habit; 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-110mg Dicalcium Phosphate-67mg Hydroxypropyl Methyl Cellulose USP (HPMC)-40mg Magnesium Stearate- 3mg

The placebo drug is identical in appearance (shape, size and color) to the test drug bupropion available in the market. It is prepared by a pharmaceutical manufacturing company.

Counselling is provided for both groups according to the 5As and 5Rs method for tobacco cessation and a separate attachment is available for further details.


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
  12. MAO Inhibitors (phenelzine)
  13. Levodopa
  14. Amantadine


Primary outcome(s)

1.
  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.
  1. 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.

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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]

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Secondary outcome(s)

1.
  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.

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.

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’.

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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.

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Target number/sample size

150 (75 each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2022-10-01


Anticipated end date

2024-04-30


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Centre for Research in Oral Cancer, Faculty of Dental Sciences, University of Peradeniya


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2021-12-14


Approval number

2021/EC/50


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Peradeniya.
Institutional Address:Faculty of Medicine, Galaha Road, Peradeniya, Sri Lanka
Telephone:+94812396361
Email: chairpersonierc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Prof. Ruwan Jayasinghe
Professor of Oral Medicine and Radiology
Department of Oral Medicine and Periodontology Director, Centre for Research in Oral cancer, Faculty of Dental Sciences, University of Peradeniya
0813130098
+94777373689
0812388948
ruwanduminda@yahoo.com

Contact Person for Public Queries

Prof. Ruwan Jayasinghe
Professor of Oral Medicine and Radiology
Department of Oral Medicine and Periodontology Director, Centre for Research in Oral cancer, Faculty of Dental Sciences, University of Peradeniya
0813130098
+94777373689
0812388948
ruwanduminda@yahoo.com


Primary study sponsor/organization

Centre for Research in Oral Cancer

Faculty of Dental Sciences, University of Peradeniya
0813130098
0812388948
croc.pdn@gmail.com
http://www.pdn.ac.lk/centers/croc/index.php

Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results