Clinical trial NCT03010761: Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer
Official title: Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Addiction
Keywords: addiction
betel-quid
drug therapy
clinical trial
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 90
Sex: MALE
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: We'll 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.

Eligibility criteria: Inclusion Criteria:

* DSM-V criteria suitable for betelnut use disorder
* No severe physical disorder
* No major psychiatric illness
* Chinese Speaker

Exclusion Criteria:

* Severe physical disorder
* Major psychiatric illness
* Inability to understand the whole protocol

Primary outcomes:
measure: betelnut use severity rating scale for addiction severity of betelnut
timeFrame: 8 weeks
Secondary outcomes:
measure: Hamilton Depression Rating Scale for depression
timeFrame: 8 weeks
measure: Beck depression index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace& Company)
timeFrame: 8 weeks
measure: Beck anxiety index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace& Company)
timeFrame: 8 weeks
measure: betelnut use Yale-Brown Obsessive Compulsive Disorder-like Scale for the craving status
timeFrame: 8 weeks
measure: betelnut metabolites urinary analysis
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: China Medical University Hospital
name: Ko Ying-Chin, PHD
role: STUDY_DIRECTOR
References: