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

NCT03010761 | Terminated Phase 2 DMC

• 1 other identifier: C103RE1059
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Addiction

Keywords

addiction; betel-quid; drug therapy; clinical trial

Outcome Measures

Primary Outcomes (1)

• betelnut use severity rating scale for addiction severity of betelnut

  The betelnut severity rating scale is a questionnaire rated by the psychiatrist or trained psychologist/nurse, containing 21 yes or no questions about betelnut use

  8 weeks

Secondary Outcomes (5)

• Hamilton Depression Rating Scale for depression

  8 weeks

• Beck depression index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace& Company)

  8 weeks

• Beck anxiety index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace& Company)

  8 weeks

• betelnut use Yale-Brown Obsessive Compulsive Disorder-like Scale for the craving status

  8 weeks

• betelnut metabolites urinary analysis

  8 weeks

Study Arms (3)

medication pills 1: escitalopram 10mg

EXPERIMENTAL

10mg once daily, 8 weeks

Drug: escitalopram

medication pills 2: moclobemide 150mg

EXPERIMENTAL

150mg once daily, 8 weeks

Drug: Moclobemide

medication pills 3: Placebo - Cap

EXPERIMENTAL

placebo once daily, 8 weeks

Drug: Placebo - Cap

Interventions

escitalopram DRUG

antidepressant use for the betel-quid abstinence

Also known as: Lexapro

medication pills 1: escitalopram 10mg

Moclobemide DRUG

antidepressant use for the betel-quid abstinence

Also known as: yutac

medication pills 2: moclobemide 150mg

Placebo - Cap DRUG

Placebo - Cap

medication pills 3: Placebo - Cap

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University Hospital: lead

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Escitalopram; Moclobemide; bisaramil

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Ko Ying-Chin, PHD

  China Medical University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: January 5, 2017
• Study Start: January 14, 2016
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share