Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer
Status:
Terminated
Trial end date:
2018-01-31
Target enrollment:
Participant gender:
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.