The Efficacy of Ibogaine in the Treatment of Addiction; an non-controlled, non-blind study , on the effect of a single dose of ibogaine in opioid-dependent subjects
- Conditions
- Dependence on opiate narcoticsTherapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]
- Registration Number
- EUCTR2014-000354-11-NL
- Lead Sponsor
- Radboud UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
•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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.<br> <br>;Secondary Objective: 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.<br>3. To investigate the decrease in numbers of drop-out during treatment after detoxification. <br>4. To investigate the safety of ibogaine during acute in-hospital opioid withdrawal and during a 6 month post treatment evaluation.<br>5. Secondary objectives concern the exploration of possible predictive factors for response on ibogaine (demographics, pretreatment ERP’s).;Primary end point(s): The main study parameters are number of relapse, experienced subjective craving after detoxification, ;Timepoint(s) of evaluation of this end point: Follow-up at 2, 4, 8, 12, and 24 weeks after the intervention
- Secondary Outcome Measures
Name Time Method 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.;Timepoint(s) of evaluation of this end point: Follow-up at 2, 4, 8 weeks after the intervention