Mental and behavioral disorders due to cocaine use - dependence syndrome
Conditions
Interventions
This is a phase II/III randomized, multicenter, double-blind clinical trial. In Part 1, 16 participants will be randomized in a 1:1:1:1 ratio into four treatment groups: ibogaine 9 mg/kg, ibogaine 12
to ensure blinding, both ibogaine and placebo will be encapsulated in capsules with the same appearance, color, odor, and taste, packaged in identical blisters. Each blister card will have a unique nu
C25.775.300
Sponsors
Instituto Veracruz de Pesquisa e Tratamento da Dependência Química Ltda.
Instituto Veracruz de Pesquisa e Tratamento da Dependência Química Ltda.
Eligibility
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Volunteers able to understand the study procedures and voluntarily consent by signing the Informed Consent Form. Men and women aged between eighteen and fifty-five years. Diagnosis of mental and behavioral disorders due to use of cocaine, dependence syndrome or mental and behavioral disorders due to multiple drug use or use of other psychoactive substances, dependence syndrome, classified as severe. Clinical, physical and psychological evaluation within normal limits or with alterations not clinically significant at the investigators discretion. History of at least one unsuccessful attempt to reduce or cease substance use, such as hospitalization, therapeutic community treatment, self help groups or psychological follow up. Agreement to maintain abstinence from cocaine and or crack for thirty days prior to administration of the investigational product. Agreement to maintain abstinence and washout from other substances and medications prior to administration of the investigational product. Availability to participate in all stages of the protocol, including twenty four hours of hospitalization and twenty four weeks of outpatient follow up
Exclusion criteria
Exclusion criteria: Volunteers with a history of severe cardiovascular diseases including angina, acute myocardial infarction, coronary artery disease, heart failure, arrhythmias, endocarditis, syncope of unknown origin or significant electrocardiographic alterations. Uncontrolled systemic arterial hypertension. Uncontrolled diabetes mellitus. Clinically relevant hepatic, renal, gastrointestinal, pulmonary, hematological or metabolic diseases. Previous diagnosis of severe neurological or psychiatric disorders such as schizophrenia, bipolar disorder, other psychoses, epilepsy, Alzheimers disease, Parkinsons disease or head trauma with loss of consciousness. Previous or current history of suicidal ideation. Previous treatment with ibogaine or noribogaine. Known hypersensitivity to ibogaine, its derivatives or excipients of the investigational product formulation. Clinically significant alterations in safety laboratory tests or in the twelve lead electrocardiogram that may endanger the participants health at the investigator’s discretion. Use of antidepressants within thirty days before administration of the investigational product. Use of nicotine within twelve hours before or forty eight hours after administration of the investigational product. Use of alcohol within fifteen days prior to administration. Confirmed pregnancy or lactation. Positive serology for HIV, hepatitis B or hepatitis C. Positive drug test on the day of ibogaine administration except for substances for which there is no restriction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of a single administration of ibogaine compared to placebo in reducing cocaine and crack use, measured through serial urine toxicology tests for cocaine metabolites at predefined time points over 24 weeks of follow-up, as well as through validated structured self-reports of substance use and standardized clinical scales of craving, motivation, and quality of life, with the main primary outcome being the proportion of participants abstinent from cocaine and crack during the 24-week period | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of ibogaine through clinical monitoring of vital signs, serial laboratory tests of hepatic, renal, hematological, and metabolic function, as well as 12-lead electrocardiograms at predefined time points. To evaluate the impact of the intervention on symptoms of anxiety and depression measured by validated clinical scales. To evaluate the maintenance of engagement in post-intervention integration psychotherapy. To evaluate adherence to outpatient follow-up during 24 weeks. To evaluate the time to relapse in participants who return to cocaine or crack use;To evaluate changes in neuropsychological and cognitive parameters through standardized test batteries applied at predefined time points. To evaluate changes in biological markers related to oxidative stress, immune function, and neuroplasticity. To evaluate possible alterations in brain areas involved in consciousness, perception, and emotional regulation through functional and structural neuroimaging when available. To evaluate the impact of the intervention on quality of life, social relationships, and occupational functioning of participants | — |
Countries
Brazil
Contacts
Public ContactCélia Regina Moraes
Instituto Veracruz de Pesquisa e Tratamento da Dependência Química Ltda.
Outcome results
None listed