Naltrexone (50 mg day−1) |
12-week open clinical trial 20 amphetamine-dependent patients |
Primary outcomesAdverse events Compliance to medication (assessed by by the presence of naltrexone's metabolite, 6-beta-naltrexol in urine) Tolerability: patient's self-report and observed adverse effects along with plasma markers of hepatotoxicity. |
No serious adverse events Moderate rates of compliance Decrease of amphetamine use |
Small sample size Open label design High attrition rate |
[112] |
Naltrexone (50 mg day−1) |
Randomized double-blind placebo-controlled design. 20 abstinent amphetamine-dependent patients DSM-IV criteria for ADHD Drug-free from amphetamine for a minimum of 30 days Residence in Stockholm county. |
Primary outcomeDifference in subjective measures of amphetamine effects (use of a Visual Analog Scale). Secondary outcomesEffects of naltrexone on physiological and biochemical responses to amphetamine, as measured by changes in blood pressure, heart rate, skin conductance and cortisol. |
Significant decrease of the subjective effects produced by dexamphetamine Reduction in dexamphetamine craving No difference between the groups on the physiological measures. |
Study was conducted in a small homogenous population of male amphetamine-dependent individuals. Small dexamphetamine dose |
[113] |
Naltrexone (50 mg day−1) |
12-week double-blind, placebo-controlled clinical trial 80 treatment-seeking amphetamine-dependent individuals Amphetamine use on at least 12 days in the past 12 weeks. |
Primary outcomeNumber of negative amphetamine urine samples during 12 weeks of treatment (of a total of 24 samples) Secondary outcomesTreatment retention Medication adherence Craving Pill count Adverse events |
Decrease in amphetamine use High treatment retention and medication adherence Significant reduction in craving No serious adverse events |
Sample selected for the study did not achieve an equal representation of the genders. Treatment outcomes assessed for 3 months Long-term effects in this population are unknown. |
[114] |