Addiction Treatment Strives for Legitimacy

  Addiction Treatment Strives for Legitimacy

Posted by CN Staff on December 25, 2002 at 10:06:00 PT
By Brian Vastag 
Source: JAMA 

New York -- Some drugs are made in laboratories. Others, like penicillin, are discovered by accident. And then there's ibogaine, a sacramental substance from West Africa that some say interrupts heroin, cocaine, and other addictions. Over the past 40 years, the tale of ibogaine's flirtation with legitimacy boasts more twists than the roots of Tabernanthe iboga, the shrublike source of ibogaine.
After riding the backpacks of Westerners to the radical 1960s New York City underground, ibogaine rose from a counterculture star to a serious project funded by the National Institutes of Health (NIH). In 1995, after spending several million dollars on laboratory and animal studies, the NIH decided not to pursue ibogaine development. Since then, patent disputes have divided the drug's champions; a growing network of informal clinics has sprung up; and pharmacologists have discovered that ibogaine works on the brain in a manner unlike that of any other known drug.After all this, ibogaine and two of its derivatives appear closer to legitimacy now than ever before. In 1998, a University of Miami Medical Center researcher opened an ibogaine clinic on the Caribbean island of St Kitt's. Although the US Food and Drug Administration (FDA) had approved human trials with ibogaine, Deborah Mash, PhD, associate professor of neurology and pharmacology at Miami, could not secure funding for a stateside study. Instead, she solicited private investment and won favor from the government of St Kitt's, where a team of physician counselors and addiction specialists now collect data that Mash hopes will cement support for US trials of ibogaine or its metabolite, noribogaine.Tabernanthe iboga, the West African source of ibogaine, used by some to treat addiction. Meanwhile, another pharmacologist, Stanley Glick, MD, PhD, director of the Center for Neuropharmacology and Neuroscience at Albany Medical Center, has painstakingly moved a derivative of ibogaine toward its own clinical trial. After 12 years of basic research on scores of molecular variations on the ibogaine theme, Glick recently forged an agreement that represents his best chance for a clinical trial. Signed in November 2002, the contract obligates investors to raise $5 million within 2 years to fund the first human studies of 18-methoxycoronaridine (18-MC).But even as ibogaine's supporters sniff success, they worry that the drug's origins will continue to stunt its development. "It's been a continuous battle for respect," said Glick. "Ibogaine has really become notorious because it didn't originate in a lab, but in the counterculture."Mash is concerned that burgeoning unsanctioned use will compromise years of laboratory and clinical work. "We've got this explosion of underground clinics, and I'm scared that everything I work for is going to go right down the toilet," Mash said in a recent telephone interview. As an endowed, tenured professor, Mash has all the right credentials: a 29-page curriculum vitae listing 155 publications; a history of millions of dollars in federal grants; a spot at the table of several National Institute on Drug Abuse (NIDA) review committees; and a reputation as a brilliant brain scientist.And yet, Mash feels that ibogaine's tumultuous history has isolated her. "I'm the only one [doing clinical research]," she said. "I figured, somebody ought to test the damn thing. You know, either it works or it doesn't." SCIENTISTS LOOK INTO USE In 1999, Kenneth Alper, MD, PhD, assistant professor of psychiatry at New York University School of Medicine, hosted the first serious scientific conference devoted to ibogaine. He and Glick compiled the proceedings into a thick volume (Alkaloids Chem Biol. 2001;56:1-330). In the preface, Geoffrey Cordell, PhD, a pharmacology researcher at the University of Illinois at Chicago, writes that while ibogaine probably "won't save the world from addiction," it deserves a "prominent position in the list of anti-addictive strategies" under study.Animal data support Cordell's conclusion. Dozens of articles referenced in the conference proceedings report reductions in self-administration of morphine, heroin, cocaine, alcohol, and nicotine in rodents given ibogaine. The effects last from 1 to 5 days, depending on dosage and other variables. Noribogaine and 18-MC produced similar results.That means the central hurdle for ibogaine's supporters is amassing compelling human data. While unknowable scores of addicts continue ingesting ibogaine hydrochloridea purified powderor ibogaa whole-plant extract containing a dozen or more active alkaloidsfew trained researchers witness the events."There's basically one big uncontrolled experiment going on out there," said Frank Vocci, PhD, head of antiaddiction drug development at NIDA.Consequently, supporters have had to rely on anecdotal accounts. At a pivotal 1995 NIDA meeting, Howard Lotsof, credited with discovering ibogaine's purported antiaddictive potential, presented a collection of case reports. He reported that 10 (19%) of 52 treatments led to cessation of heroin or cocaine use for a year or longer; 15 (29%) treatments led to 2 months or less of sobriety. The remaining treatments were followed by sober periods between 2 months and 1 year. Despite Lotsof's report, the NIDA peer review panel voted nine to four to reject a clinical grant application from Mash.She regrouped and eventually opened the Healing Visions clinic in St Kitt's. In 2000, Mash and colleagues published the data from 27 cocaine- or heroin-addicted patients treated at the center (Ann N Y Acad Sci. 2000:914;394-401). The researchers conclude that "self-reported depressive symptoms and craving were significantly decreased" at 1 month after stopping treatment with ibogaine. They also note that ibogaine treatment "decreased participants' desire and intention to use heroin." Mash is now analyzing safety and efficacy data for 257 patients.SAFETY CONCERNS At Healing Visions, patients receive what Mash calls "state-of-the-art care," with round-the-clock monitoring and access to the latest emergency equipment. But individuals who seek out ibogaine in other settings receive no such supervision. "It's caveat emptor," said NIDA's Vocci.Vocci also said that safety was "not the main concern" at the pivotal 1995 NIDA meeting, which he chaired. However, that review panel did cite safety issues. One reviewer wrote that the drug's toxicology profile was "less than ideal," with bradycardia leading the list of worrisome adverse effects.In fact, between 1989 and 2000, three reports of patients dying after taking ibogaine surfaced, sparking a swirl of questions about the drug's safety. The first death, of a 40-year-old woman in France, apparently stemmed from preexisting heart disease. A lack of medical information hindered investigations into the other two deaths and led to conflicting conclusions about whether ibogaine was to blame.In a 1996 radio interview with WBAI in New York City, Mash said that, in the French case, the patient "was very sick, she had a very sick heart and she shouldn't have been given ibogaine under any circumstances. . . ." And in the second death, "we don't completely know the mechanism of lethality, but it did appear to be respiratory collapse in this case. The bottom line is that you need to be under medical supervision. . . . Ibogaine is an important drug but it is not to be used outside the medical establishment, not ever, ever, ever."Despite Mash's warnings, unsanctioned ibogaine use appears to be soaring. A sophisticated "underground railroad" of sorts has sprung up in New York, spearheaded by Dana Beal, a long-time marijuana legalization advocate. When heroin- or cocaine-addicted individuals develop an interest in ibogaine, they often call Beal, who acts as intake counselor.During an interview in his home, the one-time headquarters of the radical 1960s Yipster Times newspaper, Beal said that if he thinks someone is a good candidate for ibogaine, he helps arrange a visit to an informal clinic.The best known operation, according to Beal, is in the Netherlands at the Amsterdam home of Sara Glatt, who practices various types of alternative medicine. Glatt has treated some 85 people during the last 3 years. When an addicted individual arrives, Glatt asks for a history of heart problems or bad experiences with psychedelic drugs. Judging from that information and the individual's weight, Glatt provides between 2 g and 6 g of powdered iboga, the whole-plant extract that contains at least a dozen active ingredients in addition to ibogaine.Whereas Glatt charges upward of $1000 for her services, the newest clinic, in Vancouver, British Columbia, offers free ibogaine. The clinic's founder, Marc Emery, won 2000 of 140 000 votes in the 2002 Vancouver mayoral election running on a platform of open access to ibogaine. He recently solicited an ibogaine e-mail list for feedback on a proposed treatment regimen.Lotsof, on the other hand, has already published a rigorous protocol (Lotsof H, Wachtel B. Manual for Ibogaine Therapy: Screening, Safety, Monitoring, and Aftercare, First Revision. Published online. Available at: -- Accessed November 26, 2002 In the preface to the first revision, Lotsof and coauthor Boaz Wachtel write that the manual is "intended for lay-healers who have little or no medical experience, but who are nevertheless concerned with patient safety and the outcome of ibogaine treatments." The manual suggests inclusion and exclusion criteria, ibogaine regimens and doses, and considerations for posttreatment care. A naive physician would likely accept it as a standard medical protocol.Back in the realm of sanctioned drug development, Glick and Mash are now focused on bringing their respective ibogaine derivatives into clinical trials. "That's certainly the way to go now," said Vocci. Alper voiced a similar opinion, saying that he views ibogaine as proof of concept that the best hope for a therapeutic drug lies with ibogaine derivatives. Glick, too, is certain that the FDA will never approve ibogaine. In addition to safety concerns and the drug's social history, the hallucinogenic effects of ibogaine could be problematic.After NIDA rejected ibogaine clinical trials, both Mash and Glick struck out with the pharmaceutical industry, which has been traditionally cool to antiaddiction drugs. The Pharmaceutical Research and Manufacturers of America (PhRMA) reports that in 1999, for example, its roster of drug giants had 10 antiaddiction agents in clinical trials. The same companies had more than 400 cancer drugs in clinical development. When asked to explain the disparity, Jeff Trewhitt, spokesman for PhRMA, said, "We certainly don't know a reason, unfortunately."But ibogaine researchers and others, including a spokeswoman for the Substance Abuse and Mental Health Services Administration (SAMHSA), say that addiction stigma and low profit potential are keeping companies away.Whatever the case, the dearth of pharmaceutical and other treatments means that the societal costs of addiction will continue to climb. SAMHSA reports that in 2000, illicit drug addiction cost the United States $160 billion in medical care, lost productivity, and crime and incarceration, up from $117 billion in 1997. Illicit drug addiction is here to stay.So too, it appears, is ibogaine. An Odd Drug Other hallucinations passed before my eyesburning skulls and faces, the figures of women in black dresses stretching out long white arms toward me from the edges of my visionbut when I tried to speak of them, they disappeared. Meanwhile, the iboga was making me sick. I fought back waves of nausea. I wanted to reach the deeper visionary state, but I was also afraid of the drug.Journalist Daniel Pinchbeck, in Breaking Open the Head: A Psychedelic Journey Into the Heart of Contemporary Shamanism. New York, NY: Broadway Books; 2002.At low doses, ibogaine is a mild stimulant. At high doses, users report deeply emotional visions, sometimes pleasant, sometimes harrowing. Patrick Kroupa, who credits ibogaine with 3 years of sobriety after 15 years of addiction, said, "It was like dying and going to hell 1000 times."Whatever the subjective experience, pharmacologists have spent decades puzzling out the brain effects of ibogaine. Their conclusion: it's unlike any other known drug. Kenneth Alper, PhD, assistant professor of psychiatry at New York University School of Medicine, said that the drug appears to work on "every neurotransmitter system we know about." It binds to N-methyl-D-aspartate receptors and µ- and -opioid receptors; all three play prominent roles in current theories of addiction.Ibogaine also acts as an antidepressant by binding to serotonin transporters, thereby increasing serotonin levels in the nucleus accumbens. Evidence of impact on the dopamine and acetylcholine systems is less compelling, but deserves consideration, said Alper (Alkaloids Chem Biol. 2001;56:2-33).Most recently, Stanley Glick, MD, PhD, published support for his theory that ibogaine reduces drug-seeking behavior in rodents by blocking a3b4 nicotinic receptors (Eur J Pharmacol. 2002;438:99-105).Meanwhile, Deborah Mash, PhD, a neuroscientist at University of Miami Medical Center, is convinced that ibogaine is nothing but a short-acting prodrug. It quickly metabolizes into noribogaine, she said, which boasts a half-life so long that she has been unable to measure it. This property, she believes, explains ibogaine's purported ability to block drug cravings for weeks or months (Alkaloids Chem Biol. 2001;56:79-113).B.V.A Brief History of Ibogaine1885: First published description of religious use of Tabernanthe iboga in Gabon appears in France; it reports that initiates of the Bwiti religion eat rootbark to induce visions and "meet their ancestors."1939: Sold in France as a stimulant until 1970.1962: Howard Lotsof, a 19-year-old from Staten Island, receives ibogaine from an LSD chemist and gives it to 19 other people. He later reports that five of seven heroin and cocaine addicts in this group, including himself, stop illicit drug use for up to 18 months and experience little or no acute withdrawal.1970: The US Food and Drug Administration (FDA) classifies ibogaine as a Schedule I drug, making it illegal. Belgium also outlaws ibogaine, but today it remains legal in the rest of the world.1985: Lotsof receives a US patent for use of ibogaine in opioid withdrawal. Additional patents describing ibogaine treatment for cocaine and other addictions follow.1989: Ibogaine addiction treatment begins in informal clinics in the Netherlands. By 2002, informal clinics have opened in the United Kingdom, Canada, Slovenia, and Mexico.1991: After intense pressure from activists, the National Institute on Drug Abuse (NIDA) begins funding preclinical toxicology and other laboratory research on ibogaine.1993: The FDA approves a US clinical trial of ibogaine sponsored by University of Miami neuroscientist Deborah Mash, PhD.1995: NIDA review committee rejects funding for Mash's clinical trial.1999: Mash opens ibogaine clinic on Caribbean island of St Kitt's. By late 2002, she has collected safety and efficacy data on 257 addicted patients.2002: Long-running legal dispute between Lotsof and Mash ends with the University of Miami winning patents for noribogaine, a metabolite of ibogaine. Stanley Glick, MD, PhD, director of the Center for Neuropharmacology and Neuroscience at Albany Medical Center, signs contract to bring ibogaine derivative 18-MC into clinical trials.B.V.Source: Journal of the American Medical Association (US)Author: Brian VastagPublished: Vol. 288 No. 24 - December 25, 2002Copyright: 2002 American Medical AssociationWebsite: JAMA-letters ama-assn.orgRelated Articles & Web Site:The Staten Island Project: The Ibogaine Story Test Hallucinogens for Mental Ills For Heroin Addicts, A Bizarre Remedy

Home    Comment    Email    Register    Recent Comments    Help


Comment #10 posted by FoM on December 26, 2002 at 22:55:53 PT

Nuevo Mexican 
Nice to see you but I understand if you don't want to comment. If people don't want to say anything about the articles here that's ok. I'd rather not talk about this subject. Thanks in advance. 
[ Post Comment ]


Comment #9 posted by Nuevo Mexican on December 26, 2002 at 22:47:09 PT

Hello to all!
I love FOM and all the gang here, but don't comment anymore as the great contributors here have gone silent for some reason, so I hope my silence is in solidarity with those whose voices are not being heard. We all know what happened here, and I for one am very depressed that our worst case scenario has already manifested here at this wonderful website for some reason or another, there is and will be no other site like this one, and until one appears, I will be in mourning. I never thought it would happen here, but then, I always hoped what has happened to America wouldn't happen either! Sad for the holidays, happy to be with my genetic family though! Wake up America, we are the evil we project onto the world. Just the way it is for now, lets pray for change, as it too is inevitable! May 2oo3 see the return of the planet/orb Nebiru, as it is scheduled to arrive this year, at the earliest. Just read 'The Explorer Race' by Zachariah Sitchken, and you will be hopeful, as our 'fall' will bring the ultimate renewal of the planet and our species. Far out stuff, but look at the state of the world and tell me Shakespear could have written this horrible tragicomedy. It is beyond beyond! In the meantime, I want my old Cannabis News! Thanks for the concern Congressman Suet! And blessings to everyone here, especially FOM and Mate! Peace!
[ Post Comment ]


Comment #8 posted by FoM on December 25, 2002 at 22:36:27 PT

Christmas really is for the children and it sounds like yours had a wonderful day. That's nice to hear.
[ Post Comment ]


Comment #7 posted by druid on December 25, 2002 at 22:27:54 PT:

We had a great Christmas thank you. My daughter was more excited this year than ever before and my little son tore open the presents with vigor. She is getting to that age where she might start questioning the myth but this website we went to last night drove her out of her mind in anticipation of Santa! :) They have live feeds of santa flying through the night and lots of other stuff. www.noradsanta.orgNORAD
NORAD is the bi-national American and Canadian military organization responsible for the aerospace defense of the United States and Canada.WorldCom Government Markets is pleased to provide the toll-free number -- 877-Hi-NORAD -- so that children across the United States and Canada can track the whereabouts of Santa Claus on Christmas Eve. Learn more about us at 

[ Post Comment ]


Comment #6 posted by FoM on December 25, 2002 at 21:52:42 PT

We had a good Christmas and hope you did too. We watched a lot of Christmas Specials. I'll be glad when the news picks up though. I don't think it will until after the new year begins. News is always slow this time of year. Writers take breaks so that means nothing much to post. 
[ Post Comment ]


Comment #5 posted by druid on December 25, 2002 at 21:48:08 PT:

Merry Christmas!
Merry Christmas! I hope you all had a very good one and I hope your new year is better than ever before!
[ Post Comment ]


Comment #4 posted by FoM on December 25, 2002 at 16:56:01 PT

Hi CongressmanSuet 
Merry Christmas! There just isn't any news and it probably will stay slow until after the New Year. I think we all need time to take a mental break from news so it doesn't become a burden to us. That way when the news takes off again we'll feel revived and your welcome! I'm looking forward to a New Year where we can accomplish good things.
[ Post Comment ]


Comment #3 posted by CongressmanSuet on December 25, 2002 at 16:52:14 PT

Oh, and FoM....

     I dont know what its like in Ohio right now, but we have about 12 inches, and its still snowing, remember how you wished for this as a kid, and now its like "Ill ask Mike to come over and plow out a driveway if the tractor is broken" It took me an hour to go 15 miles to do the horses. Times change, people change....
[ Post Comment ]


Comment #2 posted by CongressmanSuet on December 25, 2002 at 16:38:27 PT:

A good buzz....

   From all Ive read on the subject, Ibogaine seems to work as a "satisfier,ergo antidepressant[in my book], meaning that, after the initial, intense effects of the drug have worn off, it continues to chemically effect neuro-transmitters, much in the way many already prescribed drugs do, Zloft, Celerex, etc. do, but it is much more intense, and non toxic, as compared to those products, Ibogaine has been successful in treating addiction in many people. But, here is my question.... Where is everybody? Its just not quite X-mas without hearing from dddd, is he still just orbiting the planet, or has he finally decided to stay in Ca., because at least the people there understand him when he talks? Kap? Observer, jee, New Mexican, FoM, 
 the list goes on , Florida military guy? I hope everybody is having a nice X-Mas, and hopefully we will all survive these times unscathed. Times change, people's paths change, but FoM is always here for us, keeping us informed and active. Thanks especialy to you Martha.
[ Post Comment ]


Comment #1 posted by greek_philosophizer on December 25, 2002 at 11:28:38 PT:

Yes but it is a good buzz?
Lots of good info except the most important -Is it a good buzz? or a goof buzz?
[ Post Comment ]

  Post Comment