Mental and behavioral disorders due to cocaine use - dependency syndrome
Conditions
Interventions
A group of 70 cocaine and / or crack cocaine users will receive a dose of 15 mg / kg (men) or 12 mg / kg (women) of ibogaine hydrochloride, orally, with a 24-hour hospital stay and Holter cardiac moni
Drug
Behavioural
E02.319
Sponsors
Instituto Veracruz de Pesquisa e Tratamento da Dependência Química Ltda.
Prefeitura Municipal de Araguari Prefeitura de Araguari
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: QTc interval occurence between 340 and 440ms for men and between 340 and 460ms for women, observed by ECG and evaluated using the Kruskal-Wallis test and with a two-factor repeated measures method, followed by a post-hoc test of Dunnet. The data will be collected with holter 12 hours pre, 24 hours during and 12 hours post intervention and analyzed in Matlab. The occurrence of QTc above 450ms for men and 470ms for women will be considered statistically significant when the p-value is less than 0.05. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: measurement decrease - minimum 10 points and maximum 70 points - presented in applicantion of the the Cocaine Craving Questionnaire - Brief (CCQ-B) table to evaluate decrease of craving, versions for cocaine and crack. The data will be collected 1 month pre, 1 , 3 and 12 months post intervention. The result will be considered significant if the measure degree decrease, compareded before and after intervention. Will be evaluated with statistic for repeated measurements with two factors - group and time - two-way ANOVA with repeated measures.;Expected outcome 2: Decrease of the sum of points - minimum 30 points and maximum120 points - presented in the Barrat Impulsiveness Scale (BIS) table, to evaluate the reduction of impulsivity. Data will be collected 1 month before, 1, 3 and 12 months post intervention . The result will be considered significant if there is reduction of the degree presented before and after receiving Ibogaine Hydrochloride. Will be evaluated with statistic for repeated measurements with two factors - group and time - two-way ANOVA with repeated measures.;Expected Outcome 3: Decreased scores presented by the Beck Anxiety Inventory (BAI), Beck Despair Scale (BHS) and Beck Depression Inventory II (BDI-II). The result will be considered significant if there is a decrease in the degree presented before and after receiving Ibogaine Hydrochloride. Data will be collected 1 month pre, 1, 3 and 12 months post intervention. Will be evaluated with statistic for repeated measures with two factors - group and time - two-way ANOVA with repeated measures;Expected Outcome 4: Increase in the score (from 0 to 100) by applying the Global Assessment of Relational Function (GARF) table, which evaluates the quality of life. Data will be collected 1 month pre, 1, 3 and 12 months post intervention. The result will be considered significant if there is an increase in the score after receiving Ibogaine Hydrochloride. Will be evaluated with statistic for | — |
Countries
Brazil
Contacts
Public ContactBruno Daniel.;Célia Regina Chaves;Moraes
Instituto Veracruz de Pesquisa e Tratamento da Dependência Química Ltda.;Instituto Veracruz de Pesquisa e Tratamento da Dependência Química Ltda.
Outcome results
None listed