Effect of Naltrexone on cue-induced craving for Amphetamine in amphetamine dependent individuals

• Conditions: Amphetamine dependence

• Registration Number: EUCTR2006-000837-36-SE
• Lead Sponsor: Beroendecentrum Stockholm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

1) Men between the ages 20-45 years
2) Fulfils DSM IV diagnosis for amphetamine dependence
3) Consumed amphetamine for minimum of 12 times in the 12 weeks
4) Drug free 2-7 days
5) Abstinent from nicotine and caffeine during the testing day
6) Permanent home address in Stockholm
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Fulfils DSM IV diagnosis of any other substance dependence disorder (except nicotine)
2) Fulfils DSM IV diagnosis of any major psychological or psychiatric illness.
3) Traces of cannabis, opiates, cocaine, central amines or benzodiazepines in the urine at the day of testing and between the 2 testing days
4) Traces of alcohol as measured by breathalyser on the days of testing and between the 2 testing days
5) Presence of any serious somatic disorder (example, hypertension, arteriosclerosis, cirrhosis of the liver and hyperthyroidism)
6) Liver enzyme levels (for e.g., AST, ALT, GT) more than 3 times the normal levels
7) Regular use of medication that may confound the effects of the medication (e.g., pain killers, anti-depressants, psychoactive medication)
8) Renal insufficiency
9) Any previous experience with naltrexone
10) Known hypersensitivity to naltrexone
11) Participation as research subjects in clinical trial in the last 6 months.

Study & Design

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