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

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000103965

Enrollment

Registered

2011-01-31

Start date

2012-03-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

crack dependence without other psychiatric disorder living in Palmas city capable of consenting not be in treatment for at least 60 days

Exclusion criteria

cardiac moderate diseaase pulmonary moderate disease hepatic disease renal disease vascular diasease epilepsy severe malnutrition

Outcome results