The Efficacy of Ibogaine in the Treatment of Addiction; an open label, single fixed dose pilot-study of the efficacy of ibogaine in opioid-dependent subjects - Ibogaine in opioid-dependence

Radboud UMC0 个研究点目标入组 12 人开始时间: 2014年11月19日最近更新: 2021年12月6日

适应症

试验速览

暂无简介。

•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.

发起方

Radboud UMC