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
The date of last modification
Mar 27, 2023
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
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
Exclusion criteria
Primary outcome(s)
1.
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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] ] |
2.
*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] ] |
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Secondary outcome(s)
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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] ] |
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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. ] |
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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
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 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
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