chandramohan
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2006-05-04 07:39
(6173 d 19:21 ago)

Posting: # 103
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 drugs of abuse test [Design Issues]

is it necessary to do drugs of abuse test at the beginning of each study period?
Helmut
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2006-05-04 16:28
(6173 d 10:33 ago)

@ chandramohan
Posting: # 104
Views: 6,552
 

 drugs of abuse test

Dear chandramohan,

this a tricky question!

On one hand virtually all studies I have seen in the last ten years included a test for drugs of abuse at screenening and prior to administration in every treatment period (actually the evening of hospitalization).
On the other hand all sponsors - and regulators as well - were happy just with the written acknowledgment that volunteers must not take any medicinal product without permission from the investigator for a certain period of time prior to the study and during the study.

So we trust volunteers (in the case of additional medications), but we distrust them in the case of drugs of abuse.
Clearly this is not a scientific rationale, but pragmatically I would recommend the drug tests ;-)

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mitgandhi
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2006-06-15 12:34
(6131 d 14:26 ago)

@ Helmut
Posting: # 148
Views: 6,416
 

 drugs of abuse test

Dear Chandramohan & HS

As far,no regulatory authority is stating about this, it is open. Further adding to your query, for which drugs subject should be screened?

Regards
Mitesh
Helmut
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2006-06-16 16:34
(6130 d 10:26 ago)

@ mitgandhi
Posting: # 154
Views: 6,500
 

 drugs of abuse test

Dear Mitesh!

❝ [...] for which drugs subject should be screened?


Depending on your expectations on the abuse practice in the local subject recruitment area...

I would recommend benzodiazepines, amphetamine/methamphetamine, cocaine, opiates (+optional methadone), and cannabis.
I would also consider screening for barbiturates obsolete.

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chintan98
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2006-07-11 09:38
(6105 d 17:22 ago)

@ Helmut
Posting: # 161
Views: 6,375
 

 drugs of abuse test

As far as my experience says Drug abuse test should be done at the beginning of each study period. Because we have found Number of volunteers positive in this test at the beginning of Period II/III/IV. So it is advisable to do just at the beginning of each study period and it is really very easy and convenient to perform by medical nurse with the help of InstantView (KIT)

Regards,

Chintan Mehta
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