UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038597
Receipt number R000043986
Scientific Title A pilot randomized controlled trial of cognitve-behavioral therapy for substance use disorder in the Philippines
Date of disclosure of the study information 2019/11/15
Last modified on 2019/12/10 15:50:19

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Basic information

Public title

A pilot randomized controlled trial of cognitve-behavioral therapy for substance use disorder in the Philippines

Acronym

A pilot randomized controlled trial of cognitve-behavioral therapy for substance use disorder in the Philippines

Scientific Title

A pilot randomized controlled trial of cognitve-behavioral therapy for substance use disorder in the Philippines

Scientific Title:Acronym

A pilot randomized controlled trial of cognitve-behavioral therapy for substance use disorder in the Philippines

Region

Asia(except Japan)


Condition

Condition

methamphetamine use disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy of residential cognitive-behavioral therapy for amphetamine use disorder in the Philippines

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Drug use (urin testing: 3 months after discharge)

Key secondary outcomes

Drug use (self report on frequency, amount: admission, 3 months after discharge)
Relapse risk (psychologcal scale: admission, treatment termination, 3 months after discharge)
Subjective cravng (VAS: admission, treatment termination, 3 months after discharge)
Coping skills (psychologcal scale: admission, treatment termination, 3 months after discharge)
Well-being (psychologcal scale: admission, treatment termination, 3 months after discharge)
Depression (psychologcal scale: admission, treatment termination, 3 months after discharge)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Multi-element cognitive-behavioral relapse prevention program

Interventions/Control_2

Theapeutic community basd existing treatment

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

Residential patints newly admitted to Treatment Rehabilitation Centers (TRC)
Ever used methamphetamine

Key exclusion criteria

Those who are not capable of participating in group sessions
Those who cannot communiacte in Tagalog
Those who hae criminal records other than the posession of illegal drugs, possession of drug paraphernala or use of illegal drugs
Those with severe medical conditions
Those who are not considered eligible by researchers

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Takayuki
Middle name
Last name Harada

Organization

University of Tsukuba

Division name

Faculty of Human Sciences

Zip code

112-0012

Address

3-29-1 Otsuka, Bunkyo-Ku, Tokyo, Japan

TEL

+81-3-3942-5188

Email

tkharada77@gmail.com


Public contact

Name of contact person

1st name Gladys
Middle name
Last name Rabacal

Organization

JICA Philippine Office

Division name

Social Development Section, Human Security Group

Zip code

1200

Address

40th Floor Yuchengco Tower, RCBC Plaza, Ayala Avenue, Makati City, Philippines

TEL

02-88889-7119(123)

Homepage URL


Email

RabacalGladys.PP@jica.go.jp


Sponsor or person

Institute

Human Development Department
Japan International Cooperation Agency

Institute

Department

Personal name



Funding Source

Organization

Human Development Department
Japan International Cooperation Ageny

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Department of Health, Philippines

Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Tsukuba

Address

3-19-1 Otsuka, Bunkyo-Ku, Tokyo, Japan

Tel

03-3942-6919

Email

hitorinri@un.tsukuba.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

薬物依存症治療施設(ビクタン,タガイタイ,ダグパン)
Drug Abuse Treatment & Rehabilitaiton Center (Bicutan, Tagaytay, Dagupan)


Other administrative information

Date of disclosure of the study information

2019 Year 11 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2019 Year 11 Month 15 Day

Date of IRB

2019 Year 10 Month 11 Day

Anticipated trial start date

2020 Year 01 Month 31 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry

2021 Year 08 Month 31 Day

Date trial data considered complete

2021 Year 09 Month 30 Day

Date analysis concluded

2021 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 11 Month 15 Day

Last modified on

2019 Year 12 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043986


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name