The Effect of Naltrexone in Amphetamine Dependence: A Study using Functional Magnetic Resonance Imaging

• Conditions: Amphetamine dependence; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-021384-33-SE
• Lead Sponsor: Beroendecentrum Stockholm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-29
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Men between the ages 20-55 years
Fulfils DSM-IV diagnosis for amphetamine dependence
Minimum of 2 years history of amphetamine dependence
History of intravenous amphetamine use
Consumed amphetamine for minimum of 12 times in the last 12 weeks
Drug free 1-30 days (minimum 24 hours)
Abstinent from nicotine and caffeine during the testing day

A healthy control group is also selected according to the following inclusion criteria:
Men between 20-55 years, judged to be healthy by the investigator on the basis of medical history, physical examination and vital signs.
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 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Fulfils DSM-IV diagnosis of any other substance dependence disorder (except nicotine)
Fulfils DSM-IV diagnosis of any major psychiatric illness (e.g. bipolar affective disorder, schizophrenia)
Left-handedness
No clinical signs of amphetamine intoxication at the day of testing
Traces of cannabis, opiates, cocaine or benzodiazepines in the urine at the day of testing
Traces of alcohol as measured by breathalyser at the day of testing
Implant of pacemaker or any metallic object that might interfere with the magnetic field
Presence of severe somatic disorder (e.g. renal or hepatic failure)
Regular use of medication that may interact with study medication (e.g., opioid pain killers)
Experience with naltrexone during last six months
Known hypersensitivity to naltrexone

The healthy control group will be selected according to the following exclusion criteria:
Fulfils DSM IV diagnosis of any substance dependence disorder in self or in first degree relatives (parents, children or siblings)
Smoker (including snuff or any other nicotine product) and fulfils DSM IV diagnosis of nicotine dependence
Fulfils DSM IV diagnosis of any major psychiatric illness in self or in first degree relatives (parents, children or siblings)
Left-handedness
Traces of cannabis, opiates, cocaine, central amines or benzodiazepines in the urine at test day
Traces of alcohol as measured by breathalyzer at test day
Implant of pacemaker or any metallic object that might interfere with the magnetic field
Use of any concomitant medication
Known hypersensitivity to naltrexone.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified