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

Completed

• Conditions: opioid addiction; opioid dependence; 10021563

• Registration Number: NL-OMON40645
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

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

• 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are number of relapse, experienced subjective craving<br /><br>after detoxification, </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary outcome measures will consist in changes in brain activity as<br /><br>measured by Event Related Potentials (ERPs) (as measured on EEG) related to<br /><br>cue-responsivity.</p><br>