E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate if naltrexone attenuates cue-induced craving for amphetamine in amphetamine dependent individuals, as measured by psychological and physiological measures. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |