Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

ational Institute on Drug Abuse (NIDA)0 个研究点开始时间: 2009年10月22日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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.
•10)Likely to receive opioid analgesics in next 6 months associated with possible or scheduled surgery or procedure.
•11)Known hypersensitivity to naltrexone, polyactide-co-glycolide (PLG), carboxymethylcellulose, or any other component of the diluents.
•12)Female subjects who are pregnant or lactating, or of child bearing potential who are not using acceptable methods of birth control.
•13)A body habitus that precludes use of the customized needle for intramuscular injection, based on clinical judgment.
•14)Use of an investigational agent in the past 30 days.

发起方

ational Institute on Drug Abuse (NIDA)