Ignite Creation Date:
2024-05-06 @ 9:33 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03010761
Status:
TERMINATED
Last Update Posted:
2019-07-24
First Post:
2016-07-25
Brief Title:
Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
all participants finished the trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
No medication existed for BQ dependence No clinical trials existed for the drug therapy Previous study showed that BQ possessed the antidepressant effect via pathway of monoamine oxidase A MAO-A An animal model also found that the arecoline from BQ has a property as MAO-A inhibitor Therefore the investigators hypothesized that inhibition of the MAO-A or antidepressants might reduce the BQ addiction severity
The investigators will conduct the randomization and double blinded with placebo controlled study with 90 participants with BQ dependence from the Family Medicine and ear nose and throat ENT outpatient department OPD All participants shall agree the informed consent The range of age is from 18 to 65 years old The participants are diagnosed as BQ use disorder without other psychiatry co-morbidity according to the Diagnostic and Statistical Manual DSM-V criteria Those who have severe physical illness psychiatric illness and other substance use disorder except cigarettes are excluded All participants receive the semi-structure interview by DSM-V International Classification of Diseases ICD-10 and Mini International Neuropsychiatric Interview by the psychiatrist Before the intervention the participants will finish their basic data daily amount of cigarettes betel nut medical history and psycho-social rating scales Next in addition to counseling the investigators will continue or modify the optimal antidepressants based on the previous results
The investigators will evaluate their BQ use condition as what has been measured in the natural observation study of the first year The investigators will check the outcome measurement by visual analog scale betel quid withdrawal severity scale Yale-Brown Obsessive-Compulsive Y-BOCS - betel quid BQ scale The investigators also followed their hamilton depression scale Beck depression index and Beck anxiety index in the baseline 2nd 4th 6th and 8th week The investigators also obtained the participants gene type if the participants also agree for the prediction of oral cancers
The investigators will conduct the randomization and double blinded with placebo controlled study with 90 participants with BQ dependence from the Family Medicine and ear nose and throat ENT outpatient department OPD All participants shall agree the informed consent The range of age is from 18 to 65 years old The participants are diagnosed as BQ use disorder without other psychiatry co-morbidity according to the Diagnostic and Statistical Manual DSM-V criteria Those who have severe physical illness psychiatric illness and other substance use disorder except cigarettes are excluded All participants receive the semi-structure interview by DSM-V International Classification of Diseases ICD-10 and Mini International Neuropsychiatric Interview by the psychiatrist Before the intervention the participants will finish their basic data daily amount of cigarettes betel nut medical history and psycho-social rating scales Next in addition to counseling the investigators will continue or modify the optimal antidepressants based on the previous results
The investigators will evaluate their BQ use condition as what has been measured in the natural observation study of the first year The investigators will check the outcome measurement by visual analog scale betel quid withdrawal severity scale Yale-Brown Obsessive-Compulsive Y-BOCS - betel quid BQ scale The investigators also followed their hamilton depression scale Beck depression index and Beck anxiety index in the baseline 2nd 4th 6th and 8th week The investigators also obtained the participants gene type if the participants also agree for the prediction of oral cancers
Detailed Description:
Well conduct the betel-quid BQ dependence clinical trial since 2016 Eligible cases will be enrolled for the following 8 week double-blinded placebo controlled trial The groups will be divided into three groups Outcome measures include BQ use condition addiction severity rating scale emotional rating scale including Beck Anxiety Index BAI Beck Depression Index BDI Hamilton Depression Scales HAMDs and urine BQ metabolites
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None