Not Yet RecruitingPhase 1ACTRN12611000103965

Disulfiram for the treatment of crack dependence. A pilot study.

Disulfiram and placebo in the treatment of crack cocaine addiction. A pilot comparative study.


Sponsor

Laboratorio de Estudos em Neurociencias Aplicadas (LENA)

Enrollment

30 participants

Start Date

Mar 1, 2012

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This pilot study tests whether disulfiram, a medication traditionally used for alcohol dependence, can help people aged 18-40 overcome crack cocaine dependence. Participants must not have other psychiatric disorders and must not be currently in treatment.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 p

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.


Locations(1)

Tocantins, Brazil

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ACTRN12611000103965