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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000040161
Receipt No. R000045788
Scientific Title Homeopathy for cocaine-related disorders: implementing a study protocol in primary care (Cocacrack-3 study protocol)
Date of disclosure of the study information 2020/04/15
Last modified on 2021/08/02

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Basic information
Public title Homeopathy for cocaine-related disorders
Acronym Cocacrack-3 study protocol
Scientific Title Homeopathy for cocaine-related disorders:
implementing a study protocol in primary care (Cocacrack-3 study protocol)
Scientific Title:Acronym Cocacrack-3 study protocol
Region
South America

Condition
Condition cocaine-related disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the 1) the effectiveness and tolerability of homeopathic Q-potencies of Opium and Erythroxylum coca for cocaine-related disorders in a qualified primary care setting and 2) the effectiveness of a qualified primary care setting in increasing treatment attendance and retention among cocaine-crack users.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The percentage of the reported number of cocaine using days at week 6, registered through a timeline follow-back methodology.
Key secondary outcomes The percentage of the reported number of cocaine using days during participation in the study; the percentage of positive benzoylecgonine samples; cocaine craving score, daily craving episodes number, craving episodes mean duration, patient perception of medication action favoring craving reduction (assessed by Minnesota Cocaine Craving Scale); Assist score for cocaine; treatment attendance (number of attended visits/scheduled visits, including home visits); retention in treatment (period elapsed between treatment intake and dropout, i.e., last attendance to an Family Health Strategy team visit or the end of treatment); Adverse Events.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Fifty millesimal potencies of Opium will be administered in the form of sucrose globules, 1 oral globule once daily, in the morning. Fifty millesimal potencies of Erythroxylum coca will be administered in the form of sucrose globules, 1 oral globule, in the afternoon and at night. The patient may repeat the dose hourly, in case of acute craving. After inclusion, 60 patients will be randomly allocated to use homeopathy for six weeks, followed by six weeks of placebo and 60 patients will be randomly assigned to the reverse sequence. During the 6 weeks of allocation to homeopathic treatment, patients will receive LM2, LM4 and LM6 potencies of Opium and Erythroxylum coca in ascendant order, each potency for 2 weeks
Interventions/Control_2 Placebo will consist of indistinguishable sucrose globules, provided in indistinguishable vials as verum, and taken in the same posology.
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
60 years-old >
Gender Male and Female
Key inclusion criteria Assist score for cocaine between 4 and 26; capability and willingness to give informed consent and to comply with the study procedures will also be required
Key exclusion criteria negative urinary benzoylecgonine detection (< 150 ng/mL)
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Ubiratan
Middle name Cardinalli
Last name Adler
Organization Sao Carlos Federal University
Division name Medicine Department
Zip code 13565-905
Address Rod. Washington Luiz, Km 235 - Sao Carlos - SP - Brazil
TEL 005511999859753
Email ubiratanadler@ufscar.br

Public contact
Name of contact person
1st name Ubiratan
Middle name Cardinalli
Last name Adler
Organization Sao Carlos Federal University
Division name Medicine Department
Zip code 13565-905
Address Rod. Washington Luiz, Km 235 - Sao Carlos - SP - Brazil
TEL 005511999859753
Homepage URL
Email ubiratanadler@ufscar.br

Sponsor
Institute Itajai City Hall
Santa Catarina, Brazil
Institute
Department

Funding Source
Organization Itajai City Hall
(Itajai - Santa Catarina - Brazil)
benzoylecgonine tests
R$27,000 = USD 5,202 (R$ 5.19 = U$ 1.00)
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor HN-Cristiano Homeopatia -
Sao Paulo/SP/Brazil
https://www.homeopatiahncristiano.com.br/
(Laboratory/Pharmacy)
Study medication
R$ 13,680 = USD 2,636
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee - University Vale do Itajai
Address R. Uruguai, n. 458. Bloco F6. Itajai - Santa Catarina - Brazil
Tel 00554733417738
Email etica@univali.br

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 Family Health Strategy - Primary Health Care - Itajai - Santa Catarina - Brazil

Other administrative information
Date of disclosure of the study information
2020 Year 04 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 Suspended
Date of protocol fixation
2019 Year 03 Month 14 Day
Date of IRB
2019 Year 03 Month 25 Day
Anticipated trial start date
2020 Year 04 Month 22 Day
Last follow-up date
2022 Year 04 Month 07 Day
Date of closure to data entry
2022 Year 04 Month 10 Day
Date trial data considered complete
2022 Year 04 Month 10 Day
Date analysis concluded
2022 Year 05 Month 15 Day

Other
Other related information The study scenario is Primary Health Care of Itajai, a city in southern Brazil.
While our first patient was being recruited, Itajai Primary Care Unities were shut down to regular care and redirected to Covid-19. We await the resumption of regular care to (re)start the study.

August 2, 2021: Primary Care is still unavailable, and we are planning to perform the study at Secondary Care.

Management information
Registered date
2020 Year 04 Month 15 Day
Last modified on
2021 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045788

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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