Clinical Trial Results:
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
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Summary
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EudraCT number |
2014-000354-11 |
Trial protocol |
NL |
Global end of trial date |
30 Oct 2019
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Results information
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Results version number |
v2(current) |
This version publication date |
24 Dec 2022
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First version publication date |
07 May 2022
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Other versions |
v1 |
Version creation reason |
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Summary report(s) |
Safety of ibogaine administration~1 Knuijver et.al. ASI results QTc measurement per subject Summary of HR and BP measurements All SARA measurements Lab results pre and during treatment Summary of QTc measurements |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ABR47613
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Dept Psychiatry, Radboucumc, Nijmegen
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Sponsor organisation address |
Reinier Postlaan 10, Nijmegen, Netherlands, 6525 GC
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Public contact |
Dept Psychiatry 966, Radboud UMC, 31 243613490, robbert-jan.verkes@radboudumc.nl
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Scientific contact |
Dept Psychiatry 966, Dept Psychiatry, Radboudumc, 31 243613490, robbert-jan.verkes@radboudumc.nl
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Nov 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Nov 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Oct 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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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 cardiac, cerebellar and psychomimetic safety, craving and substance use during immediately after detoxificationa and during a six month follow up period.
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Protection of trial subjects |
During the 24 hours after administration of the drug, participants are in calm, single hospital room with a bed and with continuous monitoring.
Electrocardiographic monitoring (ECG) is performed every half hour for the first 12 hours. Thereafter, ECG measurements will be performed every hour in case of persistent QTc prolongation (> 450 ms for men; > 470 ms for women) or every 4 hours if automatic QTc time is shortening and below 500 ms. ECG measurements will be continued for 24 hours after administration. After 24 hours a cardiologist will assess the ECG if monitoring needed to continue. If, after administration of the ibogaine, QTc exceeds 500 ms, participants will receive a magnesium bolus infusion of 2 g in 10minutes, followed by 2 g of magnesium over the next 10 hours for myocardial stabilization. If necessary, subjects can be transferred to the coronary care unit (CCU) for continuous cardiac monitoring.
Symptoms of ataxia, delirium, and withdrawal symptoms will be monitored and scored 1,6,10 and 24 hours after drug administration.
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Background therapy |
Before ibogaine administration subjects will be given 20 mg of metoclopramide to prevent nausea for comfort and to ensure full ingestion. | ||
Evidence for comparator |
not applicable | ||
Actual start date of recruitment |
01 Apr 2014
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
6 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 14
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Worldwide total number of subjects |
14
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EEA total number of subjects |
14
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
14
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients were recruited at two outpatient addiction clinics (IrisZorg: Arnhem and Nijmegen). 36 patients deemed eligible were approached to participate; 29 patients were willing and were screened, 14 actually participated. Inclusion took place between October 2015 and November 2017. | ||||||
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Pre-assignment
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Screening details |
Inclusion criteria: 20–60 yrs of age, a wish for detoxification of opioids and prior treatment failure. Exclusion criteria: a history of clinically significant cardiac disease, serum potassium > 5.0 or < 3.5 mmol/l, severe liver or renal dysfunction or pregnancy, (a history of) psychotic symptoms, severe major depressive disorder or suicidality. | ||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
not blinded
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Arms
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Arm title
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study cohort | ||||||
Arm description |
There is only one arm | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
ibogaine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral powder
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Routes of administration |
Oral use
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Dosage and administration details |
ibogaine-HCl 10mg/kg orally
administered in a yoghurt mixture
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
14 subjects entered the study, 12 men, 2 women. Besides opioids there was other drug use 1 month prior to detoxification: Alcohol 2/14 Amphetamine 0/14 Benzodiazepines 3/14 Cannabis 4/14 Cocaine 7/14 Heroin 8/14 Tobacco 13/14 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
study cohort
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Reporting group description |
There is only one arm | ||
Subject analysis set title |
baseline data
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Baseline QTc
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Subject analysis set title |
QTc after administration
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All QTc measurements of the 24 hour period after ibogaine administration
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End point title |
difference between the QTc (ECG) before administration and the maximum QTc during the observation period [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
until 24 hoursafter drug administration
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive statistics have been used, no analysis was performed. |
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| Notes [2] - all sujects were abalyzed |
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| No statistical analyses for this end point | |||||||||
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End point title |
SARA | ||||||||
End point description |
Measurement of the severity of ataxia
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End point type |
Secondary
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End point timeframe |
During the first 24 hours (0, 2, 6, 10 and 24)
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| No statistical analyses for this end point | |||||||||
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End point title |
DOS | ||||||||
End point description |
Delerium observation scale
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End point type |
Secondary
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End point timeframe |
24 hours after administration
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
First 24 hours after drug administration
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Adverse event reporting additional description |
ECGs every half hour for the first 12 hours, then the second 12 hours every hour in case of persistent QTc prolongation
or every 4 hours if automatic QTc time was shortening and below
500 ms.
Ataxia and and psychomimetic (delirium) were assessed at 2, 6, 10 and
24 hours after administration of ibogaine.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
no dictionary used | ||||||||||||||||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
study sample
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Reporting group description |
study sample | ||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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11 Nov 2014 |
Due to financial constraints, fMRI research was dropped from this protocol |
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15 Jun 2016 |
On the 15th of June a request was made to allow a 61-year old subject to enter the study |
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14 Dec 2016 |
Intent to increase from 12 to 15 subjects (14 were eventually inlcuded)
Ibogaine INIRI monitorrapport 2 2016-12-14_draft1 |
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06 May 2019 |
Retrospective monitoring report, these are minor adjustments made to accomodate the intent of measuring depression, ataxia and delerium, aswell as bloodwithdrawals.
- Addition of: Becks Depression Inventory, SARA, SOWS and OOWS. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/33620733 |
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