Psychedelics As Psychiatric Medications by Nutt David;Castle David;

Author:Nutt, David;Castle, David;
Language: eng
Format: epub
Publisher: Oxford University Press, Incorporated
Published: 2023-03-15T00:00:00+00:00

The putative antiaddictive properties of ibogaine were first described by Howard Lotsof (Alper et al., 2001; Mash et al., 2018), who reported that ibogaine administration of 6–9 mg/kg led to an active period of visualizations described as a ‘waking dream state’, followed by an intense phase of ‘deep introspection’. Drug-dependent individuals imbibed ibogaine, report that their dream-like visions usually reflect on early childhood memories, traumas, or other significant life events. Some people recount that the experience gave them insights into their addictive and self-destructive behaviours. Opioid- and cocaine-dependent individuals report an alleviation or in some cases a complete cessation of drug ‘craving’ for extended periods, and some remain drug-free for several years thereafter following a single dose of the drug (Alper et al., 2001).

An informal addiction self-help network had provided ibogaine treatments from 1987 until 1993 to patients in Europe (Shepard, 1994). Based on his own experience and that of six of his friends, Lotsof formed a company and filed a series of use patents describing a method for treating narcotic, psychostimulant, nicotine, alcohol, and polydrug dependence with ibogaine (US Patents 4,499,096; 4,587,243; 4,857,523). In 1993 the Drug Abuse Advisory Panel of the US FDA granted an academic investigator-initiated Phase 1 Pharmacokinetic and Safety Trial in male subjects (IND 39,680; Mash et al., 2018). This clinical protocol was initially limited to include only ibogaine ‘veterans’ who had (previously) detoxed with the drug because of concerns of cerebellar toxicity demonstrated in rats treated with tremorgenic doses (O’Hearn, Zhang, & Molliver, 1995; Touchette, 1995). Subsequent studies in animals and a human neuropathology case report demonstrated species-specific and dose-related cerebellar effects that suggested a low risk for neurotoxicity in the dose range to be tested (Molinari et al., 1996; Mash, 1995). Based on these and other supportive data, the FDA-approved a revised protocol in 1995 to allow the Phase 1 studies to proceed in recently abstinent in cocaine-dependent male volunteers (Mash et al., 2018).

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