Trial Review

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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.
Scientific title
Disulfiram and placebo in the treatment of crack cocaine addiction. A pilot comparative study.
Secondary ID [1] 253360 0
Nil
Universal Trial Number (UTN)
U1111-1118-8787
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
crack cocaine addiction 260895 0
Condition category
Condition code
Mental Health 259035 259035 0 0
Addiction

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 257802 0
Treatment: Other
Intervention code [2] 257938 0
Behaviour
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.
Control group
Placebo

Outcomes
Primary outcome [1] 259885 0
Mean number of days per week that use the drug. Number of days that used drug observed in self-reported daily diary.
Timepoint [1] 259885 0
Weekly from baseline for 4 weeks.
Primary outcome [2] 259886 0
Mean number of grams per week of crack cocaine used observed in self-reported daily diary.
Timepoint [2] 259886 0
Weekly from baseline for 8 weeks.
Secondary outcome [1] 268773 0
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.
Timepoint [1] 268773 0
Weekly from baseline for 8 weeks.
Secondary outcome [2] 268952 0
Presence or not of craving observed in self-reported daily diary.
Timepoint [2] 268952 0
Weekly from baseline for 8 weeks.

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
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
cardiac moderate diseaase
pulmonary moderate disease
hepatic disease
renal disease
vascular diasease
epilepsy
severe malnutrition

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was according to a
computer-generated random numbers list.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 3122 0
Brazil
State/province [1] 3122 0
Tocantins

Funding & Sponsors
Funding source category [1] 258384 0
University
Name [1] 258384 0
Federal University of Tocantins
Country [1] 258384 0
Brazil
Funding source category [2] 258385 0
Self funded/Unfunded
Name [2] 258385 0
Leonardo Baldacara
Country [2] 258385 0
Brazil
Primary sponsor type
Other Collaborative groups
Name
Laboratorio de Estudos em Neurociencias Aplicadas (LENA)
Address
Av. NS 15 ALC NO 14, 109 Norte, Caixa Postal 114 - 77001-090
Palmas - TO
Country
Brazil
Secondary sponsor category [1] 257527 0
None
Name [1] 257527 0
Address [1] 257527 0
Country [1] 257527 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260359 0
Bioethics Comitte of Federal University of Tocantins
Ethics committee address [1] 260359 0
Av. NS 15 ALC NO 14, 109 Norte, Caixa Postal 114 - 77001-090
Palmas - TO
Ethics committee country [1] 260359 0
Brazil
Date submitted for ethics approval [1] 260359 0
Approval date [1] 260359 0
Ethics approval number [1] 260359 0
002/2010

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32058 0
Address 32058 0
Country 32058 0
Phone 32058 0
Fax 32058 0
Email 32058 0
Contact person for public queries
Name 15305 0
Leonardo Baldacara
Address 15305 0
Av. NS 15 ALC NO 14, 109 Norte, Caixa Postal 114 - 77001-090
Palmas - TO
Country 15305 0
Brazil
Phone 15305 0
+55-63-32328158
Fax 15305 0
Email 15305 0
leonardobaldassara@gmail.com
Contact person for scientific queries
Name 6233 0
Leonardo Baldacara
Address 6233 0
Av. NS 15 ALC NO 14, 109 Norte, Caixa Postal 114 - 77001-090
Palmas - TO
Country 6233 0
Brazil
Phone 6233 0
+55-63-32328158
Fax 6233 0
Email 6233 0
leonardobaldassara@gmail.com

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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