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

Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03010761
• Other study ID #: C103RE1059
• Status: Terminated
• Phase: Phase 2
• Start date: January 14, 2016
• Est. completion date: January 31, 2018

Study information

• Verified date: July 2019
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 14 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive

Intervention

Drug:
• escitalopram
antidepressant use for the betel-quid abstinence
• Moclobemide
antidepressant use for the betel-quid abstinence
• Placebo - Cap
Placebo - Cap

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hamilton Depression Rating Scale for depression	for depression	8 weeks
Secondary	Beck depression index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace& Company)	self-rating for depression	8 weeks
Secondary	Beck anxiety index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace& Company)	self-rating for anxiety	8 weeks
Secondary	betelnut use Yale-Brown Obsessive Compulsive Disorder-like Scale for the craving status	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	8 weeks
Secondary	betelnut metabolites urinary analysis	arecoline, arecaidine, and N-methylnipecotic acid checked by liquid chromatography mass spectrometry (LC-MS)	8 weeks