opioid addiction opioid dependence
Conditions
Interventions
The pilot is divided into an in-patient and an out-patient phase:
1. The first phase, the in-patient phase, consists of (minimal) 10 days of
hospitalization. During a short in-patient stabilization
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are number of relapse, experienced subjective craving after detoxification, | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed