AddictionPhase 2NCT03010761
Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer
A Phase 2 study testing escitalopram and Moclobemide in people with Addiction, run by China Medical University Hospital.
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. Read more about this study
- Who is it for?
- Ages 14 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Addiction
- What is being tested?
- escitalopram and Moclobemide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2016to 31 Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- DSM-V criteria suitable for betelnut use disorder
- No severe physical disorder
- No major psychiatric illness
- Chinese Speaker
Who cannot join
- Severe physical disorder
- Major psychiatric illness
- Inability to understand the whole protocol
About this study
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.
Read the 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.
- Conditions
- Addiction
- Being tested
- escitalopram, Moclobemide, Placebo - Cap
- Keywords
- addiction, betel-quid, drug therapy, clinical trial
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
Also called Lexapro
antidepressant use for the betel-quid abstinence
MoclobemideDrug
Also called yutac
antidepressant use for the betel-quid abstinence
Placebo - CapDrug
Placebo - Cap
| Study group | Role | What they receive |
|---|---|---|
| medication pills 1: escitalopram 10mg | Experimental | 10mg once daily, 8 weeks Receives: Drug: escitalopram |
| medication pills 2: moclobemide 150mg | Experimental | 150mg once daily, 8 weeks Receives: Drug: Moclobemide |
| medication pills 3: Placebo - Cap | Experimental | placebo once daily, 8 weeks Receives: Drug: Placebo - Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (5)
Hamilton Depression Rating Scale for depression
for depression
Measured: 8 weeks
Beck depression index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace& Company)
self-rating for depression
Measured: 8 weeks
Beck anxiety index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace& Company)
self-rating for anxiety
Measured: 8 weeks
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
Measured: 8 weeks
betelnut metabolites urinary analysis
arecoline, arecaidine, and N-methylnipecotic acid checked by liquid chromatography mass spectrometry (LC-MS)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start14 Jan 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Why it stopped: all participants finished the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ko Ying-Chin, PHD, Study director, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010761
- Sponsor's protocol ID
- C103RE1059
- Status last verified
- Jul 2019
- First submitted
- 25 Jul 2016
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer
- ClinicalTrials.gov ID
- NCT03010761
- Acronym / sponsor ID
- C103RE1059
- Conditions
- Addiction
- Keywords
- addiction, betel-quid, drug therapy, clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: all participants finished the trial
- Enrolment
- 90 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| medication pills 1: escitalopram 10mg | Experimental | Drug: escitalopram10mg once daily, 8 weeks |
| medication pills 2: moclobemide 150mg | Experimental | Drug: Moclobemide150mg once daily, 8 weeks |
| medication pills 3: Placebo - Cap | Experimental | Drug: Placebo - Capplacebo once daily, 8 weeks |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-V criteria suitable for betelnut use disorder
- No severe physical disorder
- No major psychiatric illness
- Chinese Speaker
Key exclusion criteria (3 listed)
- Severe physical disorder
- Major psychiatric illness
- Inability to understand the whole protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| escitalopramAlso: Lexaproantidepressant use for the betel-quid abstinence | Drug | medication pills 1: escitalopram 10mg |
| MoclobemideAlso: yutacantidepressant use for the betel-quid abstinence | Drug | medication pills 2: moclobemide 150mg |
| Placebo - CapPlacebo - Cap | Drug | medication pills 3: Placebo - Cap |
Primary outcome
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
5 secondary outcomes
Hamilton Depression Rating Scale for depression
Time frame: 8 weeks
Beck depression index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace& Company)
Time frame: 8 weeks
Beck anxiety index, copyrighted in Chinese (The Psychological Cooperation, Harcourt Brace& Company)
Time frame: 8 weeks
betelnut use Yale-Brown Obsessive Compulsive Disorder-like Scale for the craving status
Time frame: 8 weeks
betelnut metabolites urinary analysis
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: all participants finished the trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ko Ying-Chin, PHD study director
China Medical University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing escitalopram and Moclobemide in people with Addiction, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: all participants finished the trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
betelnut use severity rating scale for addiction severity of betelnut (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.