Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

ational Institute on Drug Abuse (NIDA)0 sitesOctober 22, 2009

Overview

No summary available.

Registry

who.int

Start Date

October 22, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ational Institute on Drug Abuse (NIDA)

•Inclusion Criteria
•1\)Aged 18 or above.
•2\)Primary diagnosis of current amphetamine dependence as defined by DSM\-IV\-TR with 10 or more days of amphetamine use in the past month.
•3\)Patient and clinician identify amphetamine dependence as the main problem.
•4\)Successfully complete 7\-10 day assessment and study baseline measures at Vogur.
•5\)Abstinent from substances (alcohol, amphetamines, cannabinoid, cocaine, hallucinogens, opioids, benzodiazepines \[unless used to treat alcohol withdrawal] for at least 7 days prior to receiving study drug or placebo.
•6\)Provision of telephone numbers/contacts of three or more people that are likely to know where can be located if unable to be contacted directly.
•7\)Successfully complete 7\-10 day assessment and study baseline measures at Vogur.
•8\)Written informed consent.
•Are the trial subjects under 18? no

•Exclusion Criteria
•1\)Any liver test \>5 times the top limit of normal.
•2\)Physiologically dependent on opioids or other substances (nicotine excepted) at time of study inclusion.
•3\)Suspected or known concomitant use of opioid analgesics, positive opioid urine drug test or positive naloxone challenge.
•4\)Schizophrenia, Bipolar I or other non\-substance related psychotic disorder.
•5\)Severely depressed, suicidal or homicidal.
•6\)Dementia.
•7\)Inability to understand the informed consent.
•8\)Planning to move from the Reykjavík area or enter jail within next 6 months.
•9\)Medical problems that need immediate attention or that, in the opinion of the investigator, will interfere with ability to participate.