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About this resource
This article reports an open-label observational case series assembled from the clinical records of people admitted seeking detoxification from opioids or cocaine. This resource follows the original order and distinctions among the introduction, methods, results, and discussion. It is not a verbatim dosing guide: it separates what the study actually observed, the authors’ interpretations, and what cannot be established from the evidence.
The study population consisted of 191 people who sought treatment at the facility: 102 in the opioid-dependence group and 89 in the cocaine-dependence group. Its findings came from a particular facility using strict exclusion criteria, hospitalization, ECGs, and other monitoring. This was not a randomized controlled trial, and the paper alone cannot establish ibogaine’s efficacy or general safety. This resource also does not provide diagnosis, treatment selection, or administration instructions.
Study design
The records came from a planned 12-day inpatient program at a 12-bed facility in St. Kitts, West Indies. Every participant met DSM-IV criteria for opioid or cocaine dependence, and active use was confirmed by urine testing at admission. The sample included 144 men and 47 women who received a single oral dose of ibogaine hydrochloride at 8–12 mg/kg. The retrospective record review was conducted with University of Miami institutional review board approval, and the paper states that participants consented to the use of their clinical records for review.
Medical history, physical examination, clinical laboratory tests, and a 12-lead ECG were reviewed before admission. People with a history of stroke, epilepsy, Axis I psychotic disorders, cardiovascular disease, liver disease, HIV/AIDS, and other specified conditions were excluded. Safety was assessed through physical examination, physician evaluation of adverse events, laboratory values, vital signs, 12-lead ECG, and ECG telemetry from one hour before to 24 hours after administration. Whole-blood ibogaine and noribogaine were measured, and CYP2D6 genotype was examined.
After admission, the opioid group was switched to oral morphine for withdrawal management. A physician assessed the Objective Opiate Withdrawal Scale (OOWS, 0–13 points) before and after administration. Drug craving was assessed with the Heroin Craving Questionnaire or Cocaine Craving Questionnaire, and mood with BDI-II, POMS, and SCL-90-R. Assessments occurred before administration, at discharge, and one month after discharge when research staff could follow the participant. Repeated-measures mixed models including missing observations were used, and two-sided p values of 0.05 or less were considered statistically significant. Semi-structured interviews were also conducted with 60 participants, and subjective experiences within three days after administration were coded.
Content
Introduction in the original article
The authors explain that ibogaine is a psychoactive indole alkaloid obtained from the root of the West African plant Tabernanthe iboga, and that self-reports and case reports had described reduced opioid withdrawal and craving after a single dose. At the same time, the introduction itself cautions that prior reports frequently involved small samples, retrospective recruitment, and inconsistent measures, and that no clinical trial had yet established efficacy for opioid dependence. Genetic variation in CYP2D6 affects metabolic rate, and complex pharmacokinetics and safety concerns had impeded development; these issues formed the study’s starting point.
Methods in the original article
The program aimed to provide physical detoxification, motivational counseling, and referrals to aftercare or community support. Dependence severity was confirmed with the Addiction Severity Index and a structured DSM-IV interview. If intoxication or withdrawal made responses appear unreliable, parts of the interview were repeated later. Drug-use history and medical status were supplemented from the psychosocial assessment, and information was cross-checked.
The craving questionnaires measured desire to use, intention to use, expectations of positive outcomes from use, expectations that use would relieve withdrawal or negative mood, and a sense of being unable to control use. Mood and craving scales were analyzed by primary drug. In the subjective-experience interviews, open responses were recorded and transcribed, and analysis and comparison continued until agreement between two coders exceeded 90%. These were participants’ descriptions of experience, not objective measurements proving a pharmacologic mechanism or therapeutic effect.
Results in the original article
Among the 102 participants in the opioid group, mean age was 35.8 ± 9.9 years, duration of use 11.2 ± 8.6 years, days of use in the 30 days before admission 19.2 ± 13.0, and number of prior treatments 5.5 ± 7.2. In the 89-person cocaine group, mean age was 36.1 ± 9.1 years, duration of use 13.1 ± 6.4 years, and days of use in the 30 days before admission 9.1 ± 10.7. Prior treatment count was reported as 5.1 ± 6.1 in the table but 5.1 ± 3.1 in the text. Men made up 67% of the opioid group and 85% of the cocaine group; White participants accounted for 95.1% and 78.7%, respectively. The authors did not test sex differences because of the sample size and open-label design.
In a pharmacokinetic table of 22 representative participants, OOWS scores before administration ranged from 3 to 13, and physician-rated withdrawal findings were generally mild afterward. Ibogaine was converted to noribogaine in the intestinal wall and liver; time to maximum ibogaine concentration was 0.5–4 hours. The authors reported that exposure to the parent compound and metabolite differed by CYP2D6 genotype. The table, however, presents representative cases rather than a withdrawal effect size for all 191 participants.
For four opioid-craving factors shown in the tables, the mean related to negative mood decreased from 3.51 to 2.02 at discharge and 1.69 at one month; current intention to use decreased from 4.10 to 2.21 and 2.04; lack of control decreased from 3.23 to 2.04 and 1.64; and expectation of positive outcomes from use decreased from 4.51 to 3.74 and 2.90. Each analysis had p < 0.0001. Participant counts were 75 before administration, 74 at discharge, and 37 at one month, so the one-month values apply only to a subset of the original group.
On the Minnesota Cocaine Craving Scale, craving intensity changed from 5.51 to 1.47 at discharge and 1.96 at one month; frequency from 2.28 to 0.29 and 0.52; and duration from 2.51 to 1.36 and 1.21. Each tabled p value was 0.0001. Here too, depending on the measure, the sample decreased from 81–83 before administration to 73–75 at discharge and 24–25 at one month.
Mean BDI score was 16.5 before administration, 8.9 at discharge, and 4.5 at one month in the opioid group, and 14.3, 4.2, and 4.5 in the cocaine group. POMS and SCL-90-R changed in the same direction. These are associations on self-report scales. Without a control group, the study cannot conclude that the drug treated depression or that the drug alone caused the changes.
Among the 60 participants who completed semi-structured interviews, 61.7% reported imagery or visual changes. Although 91.7% felt the experience was useful for their drug problem, only 16.7% said they would be willing to repeat the same experience. These are aggregated subjective interpretations, not objective verification of abstinence.
Discussion in the original article
From changes in withdrawal, craving, and mood scales, the authors interpreted a single administration as potentially helping a transition from dependence to abstinence. They gave ibogaine a blood half-life of 1.6–6 hours and discussed the possibility that longer-lasting noribogaine contributed to sustained post-administration changes. Their discussion drew on a pharmacokinetic model in which more than 90% of ibogaine was eliminated by 24 hours in rapid or intermediate metabolizers while noribogaine remained high at 24 hours; this observational study did not directly prove that mechanism.
The conclusion emphasizes the need for clinical development and controlled trials. The authors themselves note that claims about abstinence rates months later have not been verified, existing cohorts cannot be compared with each other, and long-term follow-up of people treated abroad is difficult. The paper’s positive conclusions should therefore be read as the authors’ interpretations, not as identical to the observations themselves.
Results
The central direct observations were that OOWS, craving, and mood scale scores were lower after administration than before it among medically monitored participants. Lower mean scores were also reported one month after discharge, but the number successfully followed was substantially smaller. The safety assessment reported no serious adverse events or deaths within the study’s 8–12 mg/kg range.
The longer-term outcome described as a transition “from detoxification to sustained abstinence” was not consistently verified by urine testing or equivalent objective measures. Without a control group, the effects of hospitalization, the pre-administration opioid switch, psychological support, passage of time, participant expectations, aftercare, and other factors cannot be separated. The paper did not establish superiority over approved treatments, relapse prevention, long-term abstinence rates, or effects in the general population.
Limitations
This was an open-label case series without randomization or a control group, and participants had independently sought care at a particular facility. People with serious cardiovascular or hepatic disease and other conditions were excluded in advance, and the population was predominantly male and White. Selection bias is therefore substantial, and the results cannot be directly generalized to routine clinical populations or people with comorbid illness.
The principal craving and mood measures were self-reported and may be influenced by expectancy and social desirability. Missingness at one-month follow-up was substantial, and people who could and could not be followed may not have had the same outcomes. The paper states that the analysis considered possible bias from missingness, but cannot eliminate attrition itself. Long-term drug-use outcomes also lacked ongoing objective confirmation. The sample combined heterogeneous opioid and cocaine groups, and program elements other than administration occurred at the same time. One author disclosed being an inventor on noribogaine-related patents and a founder and shareholder of a development company.
Safety
The most common immediate findings were nausea and vomiting and ataxia; perceptual changes generally subsided within 4–6 hours. Headache was reported in 7% and orthostatic hypotension in 5%, and some people in the cocaine group had bradycardia and hypotension. Approximately 2% of adverse events were classified as moderate, and no serious adverse event was reported. The paper states that physical examination, safety laboratory tests, and liver-function values showed no clear change from before administration.
These results came from an inpatient setting with prescreening, intravenous fluids, physician monitoring, 24-hour ECG telemetry, and a limited dose range. The authors discussed hERG-channel effects of ibogaine and noribogaine, prior reports of QTc prolongation, and deaths associated with high or repeated dosing, polysubstance use, and cardiovascular comorbidity; they excluded people with heart rates below 50 beats per minute or QT prolongation. The absence of serious events in this study does not establish safety outside monitoring or at other doses. This is not a basis for self-administration or a dosing recommendation.
Source and rights
The original article is available as full text in PMC and through the DOI record. PMID is 29922156 and PMCID is PMC5996271. The PMC article and publisher metadata registered with Crossref identify the license as Creative Commons Attribution 4.0 (CC BY 4.0). This page follows that source, names the original authors and source, and distinguishes observations from interpretations.