Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer

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.

Conditions

• Addiction

Interventions

DRUG

escitalopram

antidepressant use for the betel-quid abstinence

DRUG

Moclobemide

antidepressant use for the betel-quid abstinence

DRUG

Placebo - Cap

Placebo - Cap

Sponsors & Collaborators

• China Medical University Hospital

  lead OTHER

Principal Investigators

• Ko Ying-Chin, PHD · China Medical University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

70 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-01-14

Primary Completion

2018-01-31

Completion

2018-01-31