ABSTRACT
Ibogaine may be effective for transitioning opioid and cocaine dependent individuals to sobriety. American and European self-help groups provided public testimonials that ibogaine alleviated drug craving and opioid withdrawal symptoms after only a single dose administration. Preclinical studies in animal models of addiction have provided proof-of-concept evidence in support of these claims. However, the purported therapeutic benefits of ibogaine are based on anecdotal reports from a small series of case reports that used retrospective recruitment procedures. We reviewed clinical results from an open label case series (N = 191) of human volunteers seeking to detoxify from opioids or cocaine with medical monitoring during inpatient treatment. Whole blood was assayed to obtain pharmacokinetic measures to determine the metabolism and clearance of ibogaine. Clinical safety data and adverse events (AEs) were studied in male and female subjects. There were no significant adverse events following administration of ibogaine in a dose range that was shown to be effective for blocking opioid withdrawal symptoms in this study. We used multi-dimensional craving questionnaires during inpatient detoxification to test if ibogaine was effective in diminishing heroin and cocaine cravings. Participants also completed standardized questionnaires about their health and mood before and after ibogaine treatment, and at program discharge. One-month follow-up data were reviewed where available to determine if ibogaine's effects on drug craving would persist outside of an inpatient setting. We report here that ibogaine therapy administered in a safe dose range diminishes opioid withdrawal symptoms and reduces drug cravings. Pharmacological treatments for opioid dependence include detoxification, narcotic antagonists and long-term opioid maintenance therapy. Our results support product development of single oral dose administration of ibogaine for the treatment of opioid withdrawal during medically supervised detoxification to transition drug dependent individuals to abstinence.
ABSTRACT
BACKGROUND: Antiretroviral therapy (ART) recently became available in the Organization of Eastern Caribbean States (OECS). Survival benefits and budgetary implications associated with universal access to ART have not been examined in the Caribbean. METHODS: Using a state-transition simulation model of HIV with regional data, we projected survival, cost, and cost-effectiveness of treating an HIV-infected cohort. We examined 1 or 2 ART regimens and cotrimoxazole. In sensitivity analysis, we varied HIV natural history and ART efficacy, cost, and switching criteria. RESULTS: Without treatment, mean survival was 2.30 years (mean baseline CD4 count = 288 cells/microL). One ART regimen with cotrimoxazole when the CD4 count was <350 cells/microL provided an additional 5.86 years of survival benefit compared with no treatment; the incremental cost-effectiveness ratio was $690 per year of life saved (YLS). A second regimen added 1.04 years of survival benefit; the incremental cost-effectiveness ratio was $10,960 per YLS compared with 1 regimen. Results were highly dependent on second-line ART costs. Per-person lifetime costs decreased from $17,020 to $9290 if second-line ART costs decreased to those available internationally, yielding approximately $8 million total savings. CONCLUSIONS: In the OECS, ART is cost-effective by international standards. Reducing second-line ART costs increases cost-effectiveness and affordability. Current funding supports implementing universal access regionally over the next year, but additional funding is required to sustain lifetime care for currently infected persons.