UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040161 |
|---|---|
| Receipt number | R000045788 |
| Scientific Title | Homeopathy on the integrative care of cocaine-related disorders: confirmatory, randomized, placebo-controlled, double-blind, crossover clinical trial (Cocacrack-3 Study) |
| Date of disclosure of the study information | 2020/04/15 |
| Last modified on | 2024/04/15 22:23:31 |
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Basic information
Public title
Homeopathy on the integrative care of cocaine-related disorders
Acronym
Cocacrack-3 Study
Scientific Title
Homeopathy on the integrative care of cocaine-related disorders: confirmatory, randomized, placebo-controlled, double-blind, crossover clinical trial (Cocacrack-3 Study)
Scientific Title:Acronym
Cocacrack-3 Study
Region
| South America |
Condition
Condition
Cocaine-related disorders
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To assess the effectiveness and safety of a sequential administration of homeopathic fifty-millesimal potencies (LM2, LM4, and LM6) of Opium and Erythroxylum coca in reducing cocaine use among participants.
2) To evaluate the effectiveness of telemedicine and a support network, whether family or otherwise in enhancing treatment retention rates among individuals with crack cocaine use disorder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Percentage of days of cocaine use at week 3, recorded by telemedicine using a timeline follow-back methodology.
Key secondary outcomes
Recorded weekly by telemedicine: The percentage of the reported number of cocaine-using days during participation in the study. Change in participant's cocaine craving measured through the Cocaine Craving Questionnaire scale - brief. Participant's progression assessed by the Clinical Global Impressions Scale. Use of concomitant medications. Occurrence of Adverse Events. Assessment of treatment adherence by the Measure Treatment Adherence scale. Evaluation of participant retention by the number of participants at weeks 3 and 6. Evaluation of study medication use by vial weight at weeks 3 and 6.
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
Sequence 1: verum for three weeks, followed by placebo for three weeks.
The verum sequence will consist of fifty millesimal potencies (LM2, LM4, and LM6) of Opium and Erythroxylum coca, used for one week each, in ascending order (Opium: given in a sucrose globule dissolved on the tongue in the morning; Erythroxylum coca: administered in a sucrose globule dissolved on the tongue in the afternoon and evening, plus an extra globule, repeated every hour for six hours, in case of craving). Placebo will consist of indistinguishable sucrose globules, provided in indistinguishable vials as verum, and taken in the same posology.
Interventions/Control_2
Sequence 2: placebo for three weeks followed by verum for three weeks.
The verum sequence will consist of fifty millesimal potencies (LM2, LM4, and LM6) of Opium and Erythroxylum coca, used for one week each, in ascending order (Opium: given in a sucrose globule dissolved on the tongue in the morning; Erythroxylum coca: administered in a sucrose globule dissolved on the tongue in the afternoon and evening, plus an extra globule, repeated every hour for six hours, in case of craving). 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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients from a participating Psychosocial Attention Center, in treatment for cocaine use disorder, with a family or other support network.
Key exclusion criteria
Remission of cocaine use greater than two weeks; impossibility or unavailability of participating in research in a virtual environment, even with family support.
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
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
ubiratanadler@ufscar.br
Sponsor or person
Institute
Brazilian Association of Homeopathic Pharmacists.
Institute
Department
Personal name
Funding Source
Organization
Federal University of Santa Catarina.
Research Laboratory of History of Nursing and Health Knowledge
Organization
Division
Category of Funding Organization
Self funding
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
Ethics Committee for Human Research at the Federal University of Santa Catarina
Address
Predio Reitoria II, R: Desembargador Vitor Lima, 222, sala 401, Trindade, Florianopolis/SC, CEP 88.040-400
Tel
00554837216094
cep.propesq@contato.ufsc.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
Psychosocial Attention Center for Alcohol and Other Drugs of Florianopolis, Sao Jose, and Palhoca-SC/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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
| 2026 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2026 | Year | 08 | Month | 20 | Day |
Date analysis concluded
| 2026 | Year | 11 | Month | 01 | Day |
Other
Other related information
The study scenario is the Primary Health Care of Itajai, a city in southern Brazil.
While our first patient was recruited, Itajai Primary Care Unities were shut down to regular care and redirected to Covid-19. Therefore, we await the resumption of regular care to (re)start the study.
August 2, 2021: Primary Care is still unavailable, and we plan to perform the study in Secondary Health Care.
December 22, 2022: After careful consideration, we have revised the study protocol. We relocated it to specialized facilities, specifically the Psychosocial Attention Centers for Alcohol and Other Drugs (CAPS-AD) in Florianopolis (on both the island and the mainland), Sao Jose, and Palhoca. These cities are all part of the greater Florianopolis area in Santa Catarina, Brazil.
August 5, 2023. Inclusion started on June 9, 2023.
October 17, 2023: Inclusion continues, currently at two Psychosocial Attention Centers for Alcohol and Other Drugs (CAPS-AD) Florianopolis and Sao Jose.
April 15, 2024: improvement in network support in CAPS-AD Sao Jose, improving adhesion.
Management information
Registered date
| 2020 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045788
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