Study of the cardiac safety of Ibogaine accompanied by psychotherapy in the treatment of addiction to cocaine and crack.

Phase 3

• Conditions: Mental and behavioral disorders due to cocaine use - dependency syndrome; C25.775.300; C25.775.835

• Registration Number: RBR-9zpc27
• Lead Sponsor: Instituto Veracruz de Pesquisa e Tratamento da Dependência Química Ltda.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Age between 18 and 50 years; complete primary education; absence of abnormalities in the evaluation of hemogram, transaminases, gamma-GT, glycemia, hepatitis C, HIV serology, Beta HCG for women, sodium, potassium, magnesium and electrocardiogram with a report attesting the absence of any abnormalities, including prolongation of the QT interval ; cocaine and / or crack dependence, with at least one unsuccessful attempt at treatment; perspective of return to family life; maintenance of abstinence from psychoactive drugs for 30 days between the initial evaluation and the medication session (ascertained by personal reporting and urinalysis of urine at all psychological visits and the day the drug is received); interruption of the use of antidepressants and mood stabilizers, under the guidance of the clinician responsible

Exclusion Criteria

Psychotic disorder; schizophrenia and any other psychiatric disorder in which you are in crisis; exams beyond normality; prolonged QT interval demonstrated on the electrocardiogram; pregnancy and breastfeeding; large surgeries in the last 6 months; uncontrolled arterial hypertension; uncontrolled diabetes; myocardial infarction and ventricular arrhythmias; hepatic insufficiency; previous history of accidents with head trauma and loss of consciousness; Alzheimer's disease; Parkinson's disease; Being a carrier of epilepsy; motor difficulties that may interfere with writing ability; do not be abstinent from psychoactive drugs for 30 days on the day you receive the drug treatment; be under the influence of antidepressants and mood stabilizing medications.

Study & Design

• Study Type: Intervention
• Study Design: Not specified