EASE trial terminated after conflicting advice
April 2006
EASE trial terminated after conflicting advice.
Stargate International today announced its decision to terminate a non-therapeutic clinical trial after receiving conflicting opinions on the legality of one of the compounds in the ecstasy alternative "EASE".
Stargate International is an organisation committed to the reduction of drug-related harm through the development of safer, legal alternatives.
Stargate Founder Matt Bowden said the trial had been conducted based on assurances from Government agencies that the substance was legal. He said with a new opinion coming to light the decision was made yesterday to immediately suspend the trial until the situation was clarified.
"There is a difference of opinion between the initial advice we received from the government and this new alternative interpretation of the law. Rather than slug this out with the government we have taken the proactive and responsible step of suspending the trial immediately.
"We apologise to all trial participants for any inconvenience caused, we are doing something new in society and it does take time to get these things right."
Mr Bowden confirmed a number of steps were taken to check that the product was legal, including informing the Ministry of Health and obtaining written consent that the product was not an analogue of a controlled drug and able to be imported into New Zealand.
The non therapeutic clinical trial was being carried out as part of a search for safer alternatives to ecstasy. The trial was raised with the Ministry of Health and the Expert Advisory Committee on Drugs 6 months ago and no objections were raised.
“This was a well conducted and controlled trial that was a part of our drive to minimize the harm caused by illegal drugs. Despite the suspension of this trial we will continue our efforts down this path because this approach saves lives,” said Mr. Bowden.
“At all times Stargate has acted in the belief we were complying with the law.
“At all times we went to great lengths to inform Government agencies of our plans. We checked the legality of this compound with the Ministry of Health and we received written consent to import it.
“While we are very surprised to now receive contradictory advice, this stage of the trial was near an end. We will continue to co-operate fully the Government and its agencies on this matter.”
ENDS