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Trial registered on ANZCTR
Registration number
ACTRN12611000103965
Ethics application status
Approved
Date submitted
24/01/2011
Date registered
31/01/2011
Date last updated
13/02/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Disulfiram for the treatment of crack dependence. A pilot study.
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Scientific title
Disulfiram and placebo in the treatment of crack cocaine addiction. A pilot comparative study.
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Secondary ID [1]
253360
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Nil
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Universal Trial Number (UTN)
U1111-1118-8787
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
crack cocaine addiction
260895
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Condition category
Condition code
Mental Health
259035
259035
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
15 subjects with crack dependence will receive oral disulfiram 250mg daily for 60 days and 15 subjects with crack dependence will receive placebo for 60 days. They will be evaluated once a week by a psychiatrist and will participate of group therapy twice a week. Each psychiatric evaluation will expend 30 minutes. Each subject will participate in cognitive behavioural group theraphy. Each group therapy session will expend 40 minutes per week and the overall duration of therapy 2 months.
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Intervention code [1]
257802
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Treatment: Other
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Intervention code [2]
257938
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Behaviour
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Comparator / control treatment
15 subjects with cocaine crack dependence using placebo (10mg oral microcellulose capsule) one capsule daily for 60 days. Subjects in this group will also participate in the cognitive behavour group therapy sessions.
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Control group
Placebo
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Outcomes
Primary outcome [1]
259885
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Mean number of days per week that use the drug. Number of days that used drug observed in self-reported daily diary.
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Assessment method [1]
259885
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Timepoint [1]
259885
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Weekly from baseline for 4 weeks.
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Primary outcome [2]
259886
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Mean number of grams per week of crack cocaine used observed in self-reported daily diary.
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Assessment method [2]
259886
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Timepoint [2]
259886
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Weekly from baseline for 8 weeks.
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Secondary outcome [1]
268773
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Side effects of disulfiram observed in self-reported daily diary. Examples of side effects are drowsiness, fatigue, metallic or garlic-like aftertaste, impotence, blurred vision, skin discoloration, dermatitis, increased heart rate, confusion; signs of jaundice, nausea, vomiting, abdominal pain, light stools and dark urine (signs of liver damage), flushing, and headache.
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Assessment method [1]
268773
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Timepoint [1]
268773
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Weekly from baseline for 8 weeks.
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Secondary outcome [2]
268952
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Presence or not of craving observed in self-reported daily diary.
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Assessment method [2]
268952
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Timepoint [2]
268952
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Weekly from baseline for 8 weeks.
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Eligibility
Key inclusion criteria
crack dependence without other psychiatric disorder living in Palmas city capable of consenting not be in treatment for at least 60 days
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
cardiac moderate diseaase
pulmonary moderate disease
hepatic disease
renal disease
vascular diasease
epilepsy
severe malnutrition
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomly selected from the Center of Psychosocial Care for Alcohol and Drugs of Palmas, Brazil. Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was according to a
computer-generated random numbers list.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/03/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3122
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Brazil
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State/province [1]
3122
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Tocantins
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Funding & Sponsors
Funding source category [1]
258384
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University
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Name [1]
258384
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Federal University of Tocantins
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Address [1]
258384
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Av. NS 15 ALC NO 14, 109 Norte, Caixa Postal 114 - 77001-090
Palmas - TO
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Country [1]
258384
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Brazil
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Funding source category [2]
258385
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Self funded/Unfunded
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Name [2]
258385
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Leonardo Baldacara
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Address [2]
258385
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Av. NS 15 ALC NO 14, 109 Norte, Caixa Postal 114 - 77001-090
Palmas - TO
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Country [2]
258385
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Brazil
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Primary sponsor type
Other Collaborative groups
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Name
Laboratorio de Estudos em Neurociencias Aplicadas (LENA)
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Address
Av. NS 15 ALC NO 14, 109 Norte, Caixa Postal 114 - 77001-090
Palmas - TO
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Country
Brazil
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Secondary sponsor category [1]
257527
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None
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Name [1]
257527
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Address [1]
257527
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Country [1]
257527
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260359
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Bioethics Comitte of Federal University of Tocantins
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Ethics committee address [1]
260359
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Av. NS 15 ALC NO 14, 109 Norte, Caixa Postal 114 - 77001-090
Palmas - TO
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Ethics committee country [1]
260359
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Brazil
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Date submitted for ethics approval [1]
260359
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Approval date [1]
260359
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Ethics approval number [1]
260359
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002/2010
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Summary
Brief summary
Some clinical trials have demonstrated success with the administration of 250mg a day of disulfiram in patients with alcohol abuse and cocaine and this effect was attributed to dopamine potentiating properties. Possibly disulfiram inhibits the enzyme dopamine beta-hydroxylase, which is involved in the catabolism of neurotransmissor.Activation of dopamine in the nucleus accumbens (pleasure center) is one of the biological theories of dependency on drugs. Disulfiram blocks also prevents plasma and microsomal enzymes responsible for metabolism of cocaine in his pathways. However, the was no study that evaluated efficacy and safety of dissulfiram in crack dependence. In the present study 30 subjects with crack dependence will be allocate in two groups: to receive dissulfiram 250mg per day by 60 days and to receive placebo by 60 days. The two groups will participate of psychological and occupational therapy treatment. The outcomes measure will be mean number of day without drug use, mean number of drug miligrams used in a week, side effects, presencer or not of craving. Our hyphotesis is that dissulfiram will be effective and safe for crack treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
32058
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Address
32058
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Country
32058
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Phone
32058
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Fax
32058
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Email
32058
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Contact person for public queries
Name
15305
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Leonardo Baldacara
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Address
15305
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Av. NS 15 ALC NO 14, 109 Norte, Caixa Postal 114 - 77001-090
Palmas - TO
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Country
15305
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Brazil
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Phone
15305
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+55-63-32328158
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Fax
15305
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Email
15305
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[email protected]
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Contact person for scientific queries
Name
6233
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Leonardo Baldacara
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Address
6233
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Av. NS 15 ALC NO 14, 109 Norte, Caixa Postal 114 - 77001-090
Palmas - TO
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Country
6233
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Brazil
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Phone
6233
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+55-63-32328158
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Fax
6233
0
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Email
6233
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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