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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03010761
Recruitment Status : Terminated (all participants finished the trial)
First Posted : January 5, 2017
Last Update Posted : July 24, 2019
Information provided by (Responsible Party):
China Medical University Hospital

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.

Condition or disease Intervention/treatment Phase
Addiction Drug: escitalopram Drug: Moclobemide Drug: Placebo - Cap Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer
Actual Study Start Date : January 14, 2016
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: medication pills 1: escitalopram 10mg
10mg once daily, 8 weeks
Drug: escitalopram
antidepressant use for the betel-quid abstinence
Other Name: Lexapro

Experimental: medication pills 2: moclobemide 150mg
150mg once daily, 8 weeks
Drug: Moclobemide
antidepressant use for the betel-quid abstinence
Other Name: yutac

Experimental: medication pills 3: Placebo - Cap
placebo once daily, 8 weeks
Drug: Placebo - Cap
Placebo - Cap

Primary Outcome Measures :
  1. betelnut use severity rating scale for addiction severity of betelnut [ Time Frame: 8 weeks ]
    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

Secondary Outcome Measures :
  1. Hamilton Depression Rating Scale for depression [ Time Frame: 8 weeks ]
    for depression

  2. Beck depression index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace& Company) [ Time Frame: 8 weeks ]
    self-rating for depression

  3. Beck anxiety index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace& Company) [ Time Frame: 8 weeks ]
    self-rating for anxiety

  4. betelnut use Yale-Brown Obsessive Compulsive Disorder-like Scale for the craving status [ Time Frame: 8 weeks ]
    Yale-Brown Obsessive Compulsive Disorder-like Scale, translated in Chinese and betelnut use craving form, a questionnaires containing 10 questions rated by the psychiatrist or trained psychologist/nurse, severity from 0-4

  5. betelnut metabolites urinary analysis [ Time Frame: 8 weeks ]
    arecoline, arecaidine, and N-methylnipecotic acid checked by liquid chromatography mass spectrometry (LC-MS)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03010761

Sponsors and Collaborators
China Medical University Hospital
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Study Director: Ko Ying-Chin, PHD China Medical University Hospital
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Responsible Party: China Medical University Hospital Identifier: NCT03010761    
Other Study ID Numbers: C103RE1059
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by China Medical University Hospital:
drug therapy
clinical trial
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors