The Committee considered the foreshadowed inclusion of mitragynine and Mitragyna speciosa in Schedule 9 of the SUSDP.

(d) 12.3 PURPOSE The Committee considered post-meeting comments in relation to the February 2004 decision to include Mitragyna speciosa (M.speciosa) in Schedule 9 of the SUSDP based on abuse potential. M.speciosa (also known as Kratom) is native to Thailand and Malaysia. Mitragynine, one of the alkaloids found in the leaves of M.speciosa, has psychoactive properties and is used as an opium or heroin substitute by Malayans (Burkill 1935). M.speciosa leaves are used extensively in Thailand (also in Malaysia) to increase work output and tolerance to direct sunlight, and are usually chewed, smoked or drunk as tea to achieve the desired affect. The leaves are chewed 3 to 10 times a day, with stimulant effects occurring after 5 to 10 minutes. M.speciosa was regulated as a narcotic drug in Thailand and carried the same restrictions and penalties as cocaine.

The NDPSC considered the inclusion of mitragynine and M.speciosa (the plant) in Schedule 9 of the SUSDP over several meetings (February 2003 to February 2004) based on abuse potential. Subsequently, the NDPSC 39th Meeting (October 2003) agreed to include the alkaloid, mitragynine, in Schedule 9 of the SUSDP and foreshadowed to consider at the February 2004 meeting the inclusion in S9 of the plant, M.speciosa. The 40th Meeting (February 2004) then agreed to include M.speciosa in S9 following consideration of several public submissions.

The Committee noted post-meeting comments from XXXXXXXXXXXX and XXXXXXXXXXXX. The Committee discussed the issues raised in post-meeting submissions in relation to matters mentioned in s.52E of the Therapeutic Goods Act 1989:

The potential hazards associated with the use of a substance

XXXXXXXXXXXX advised the Committee of the findings of the pre-clinical trial conducted in the 1960s by the then XXXXXXXXXXXX to investigate the possible therapeutic properties of mitragynine from M. speciosa. The company confirmed the report that the pre-clinical trial apparently revealed unacceptable acute effects (Raffauf 1986) and was discontinued. People taking Kratom in the `traditional method' (i.e. drinking like tea) could unwittingly become addicted based on the evidence showing that habitual chewing of Kratom leaves could lead to gradual addiction and that during early stages of addiction the user may take only a few leaves to obtain satisfactory results [United Nations Bulletin on Narcotics (1975 Issue 3)].

The extent and patterns of use of a substance

Post-meeting comment suggested that the only use in Australia had been through consumption of the lower-dose tea type preparations and therefore the risk of opiate effects was correspondingly low. A member raised the issue that given the amount of information available on the Internet about use of this substance and the fact that plants

National Drugs and Poisons Schedule Committee Record of Reasons 41 ­ June 2004 were being sold for propagation in Australia, there was no guarantee that this type of consumption and pattern of use would remain unchanged.

The Committee was advised that a large number of websites were found on the Internet promotin g the use of M. speciosa as an illicit drug with detailed instructions on how to prepare and use the plant to achieve the `desired' effects. The most common methods of use suggested were smoking the leaves, drinking infused water like tea and smoking the residue (as concentrated resin) from boiling leaf extracts until dry. Members also noted several websites on the Internet dedicated to `exposing bogus Kratom Market' suggesting a significant demand for M. speciosa.

The potential for abuse of a substance

Some post-meeting comments received opposed the decision to include M.speciosa in S9 based on the claim that there was no evidence to demonstrate harm or abuse and that the plant was beneficial for use as an analgesic, mood-elevating agent or relaxant, and substitute for opium or heroin. It was argued that consumption like normal tea of M. speciosa was without any adverse or addictive effects and on this basis the plant should not be restricted.

Members noted that the United Nations Bulletin on Narcotics (1975 Issue 3) stated in relation to a study conducted on 30 Kratom eaters in Thailand that "In the early stages of addiction the user may take only few leaves to obtain satisfactory results. The dosage is then increased in varying degrees among individual subjects: 10-20 leaves daily (40%); 21-30 leaves daily (36.6%); while the remainder of the sample increased its daily use to an indefinite number of leaves. The addicts chew about 3-10 times a day, depending on their sensation of weariness to overcome".

The psychological effects occurring after 5-10 minutes of consuming Kratom were described as feeling happy, strong and active. The UN Bulletin reported that long term Kratom addicts became thin, their skin darkened, particularly on the face (on both cheeks) which gave the appearance similar to that of a hepatic face. Five cases of Kratom addiction mentioned in the Bulletin revealed psychotic symptoms including convulsions, mental confusion, clouding of consciousness, episodes of delusions and persecutory ideation, hallucinations, dizziness and headaches. Typical withdrawal symptoms noted in Kratom addicts included hostility, aggression, flow of tears, wet nose, inability to work, aching muscles and bones, and jerky movement of the limbs.

The Journal of Psychoactive Drugs (Vol 20[4], Oct-Dec 1988) described mitragynine, the major alkaloid of M. speciosa, as a drug with a highly unusual but nevertheless welldocumented history of being described as both a depressant and a stimulant, while at the same time possessing the chemical structure one might expect of a psychedelic.

The Committee noted that almost all the human data published in recognised scientific journals about the use of M. speciosa related to traditional use in Thailand. A member indicated that whilst mitragynine is structurally unrelated to other opiates, it appeared to act on mu- and delta-opioid receptor subtypes. Since mu-opioid receptors were thought to be involved in both the analgesic action, as well as the euphoric and addictive properties of opiates, there appeared to be a pharmacological basis for mitragynine to have similar effects. The action of mitragynine on opiate receptors may also explain the use of M. speciosa as a substitute for opium and heroin. It was noted that a number of post-meeting submissions mentioned the use of M. speciosa for treating opium and heroin withdrawal symptoms. A member stated that a possible reason for the attenuation of withdrawal from opiates by M. speciosa may be compared to the concept of using methadone to treat addicts in that, pharmacologically, one opiate was used to replace another.

The need for access to a substance, taking into account its toxicity compared with other substances available for a similar purpose A Member noted that based on the available data there was little evidence to show that M.speciosa was widely used for therapeutic purposes other than as a substitute for other addictive opiates and one other traditional use as an antidiarrhoeal. Although the pharmacology of M. speciosa suggested that analgesic effects were likely given the findin gs of studies quoted in several papers [e.g. Journal of Psychoactive Drugs (Vol 20[4], Oct-Dec 1988], there was little data to suggest that Kratom was used traditionally as a pain reliever. On this basis, the Committee noted that despite post-meeting comments about the usefulness of M.speciosa for treating migraines, there was little evidence available to support a legitimate therapeutic need for the plant and members also noted that a number of other alternatives including complementary medicines were already available. A Member observed that information on Internet websites referred main ly to the use of Kratom for producing psychoactive effects and in contrast, there was paucity of information about its therapeutic use.

Any other matters that the Committee considers necessary to protect public health, including the risks (whether imminent or long term) of death, illness or injury resulting from its use

It was pointed out in post-meeting comment received that emergency scheduling is an option available to the Committee. However, members contended that in view of the evidence before the Committee on habituation to M.speciosa, as traditionally consumed in Thailand, and anecdotal evidence of abuse from numerous websites, a pro-active approach to curb the potential for abuse of M.speciosa was considered necessary to protect public health and safety.

A jurisdictional Member advised the Committee that M.speciosa had been included in a State's Prohibited Substances List, on the request of the police force due to `undesirable' activities.

The Committee confirmed the decision made at the NDPSC 40th Meeting (February 2004) to include of Mitragyna speciosa in Schedule 9 of the SUSDP based on its abuse potential.