Amphetamine dependence
Conditions
Interventions
Trade Name: Revia
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Beroendecentrum Stockholm
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if naltrexone attenuates cue-induced craving for amphetamine in amphetamine dependent individuals, as measured by psychological and physiological measures.;Secondary Objective: To investigate cognitive processes (e.g. automatic attention for appetitive cues) that may be important for eliciting cue-induced amphetamine craving for amphetamine dependent patients. ;Primary end point(s): 1) level of cue-induced subjectively reported amphetamine craving after treatment. 2) Level of cue-induced physiological amphetamine craving after treatment. 3) Degree of attentional bias towards appetitive amphetamine-related cues. | — |
Countries
Sweden
Outcome results
None listed