E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Dependence on opiate narcotics |
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E.1.1.1 | Medical condition in easily understood language |
Dependence on opiate narcotics |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behaviours [F01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. To investigate, in patients with opioid dependence, the short and long term effects of a single administration of ibogaine on craving and substance use during a six month follow up period.
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E.2.2 | Secondary objectives of the trial |
2. To investigate what effect ibogaine causes on Event Related Potentials (ERP), and functional MRI neuroimaging, as a measure of cognitive processes linked to craving.
3. To investigate the decrease in numbers of drop-out during treatment after detoxification.
4. To investigate the safety of ibogaine during acute in-hospital opioid withdrawal and during a 6 month post treatment evaluation.
5. Secondary objectives concern the exploration of possible predictive factors for response on ibogaine (demographics, pretreatment ERP’s). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Males or females 23 to 60 years of age, currently dependent on opiate narcotics, as assessed by DSM-IV (304.00) criteria.
• Wish for detoxification of the opioids used and wish for lasting abstinence.
• Did not succeed in intensive treatment as usual.
• Subjects must be willing and properly motivated to participate in the study in accordance with the study requirements as evidenced by signing a written informed consent, willing to cooperate with the investigators and willing to participate in all the evaluations.
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E.4 | Principal exclusion criteria |
• Patients with cardiac illness: Ventricle fibrillation in history, Long QT syndrome, history of syncope, QTc >500 ms on ECG at screening.
• Patients who are diagnosed with schizophrenia, patients with a history of psychotic symptoms. Severe major depressive disorder.
• Patients who are homeless.
• Pregnancy.
• Patients who are actively suicidal.
• Has any clinical significant chronic or acute cardiac, renal or medical condition or has any unstable medical condition.
• Has a disorder that would interfere with the absorption, distribution, metabolism or excretion of Ibogaine (patients with major gastrointestinal problems including ulcers, regional enteritis, or gastrointestinal bleeding; patients with liver enzymes higher than four times normal range).
• Patients who don’t have opiates and/or methadone in urine test at screening
• Patient requiring concomitant medications that may severely interfere with use of ibogaine (i.e., anti-epileptic drugs, neuroleptics, antidepressants): especially those medications which have a QT-prolonging effect and those who are significantly interfering with the CYP2D6 enzyme system.
• Patient who has received any drug known to have a well defined potential for toxicity to a major organ system within one month prior to entering the study or have previously received any investigational new drug within the previous six months. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main study parameters are number of relapse, experienced subjective craving after detoxification, |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Follow-up at 2, 4, 8, 12, and 24 weeks after the intervention |
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E.5.2 | Secondary end point(s) |
Secundary outcome measures will consist in changes in brain activity as measured by Event Related Potentials (ERPs) (as measured on EEG) related to cue-responsivity. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Follow-up at 2, 4, 8 weeks after the intervention |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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the last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |