Amphetamine abuse and dependence Mental and Behavioural Disorders Amphetamine dependence
Conditions
Interventions
This was a randomised, double blind, single-site placebo-controlled trial of Naltrexone (NTX) for amphetamine dependence. Post the lead-in period, 80 patients were randomised to either placebo or NTX
Sponsors
Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male or female between 18 to 65 years 2. Written, informed consent to participate 3. Address and telephone in the Stockholm metropolitan area where the participant can be reached 4. Amphetamine dependence according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria 5. Having used amphetamine on a minimum of 12 occasions during the 12 weeks prior to screening 6. Two consecutive urine tests with no traces of amphetamine following screening
Exclusion criteria
Exclusion criteria: 1. Opiate abuse or dependence 2. Use of any opiate preparation (legal or illicit) during 30 days prior to screening 3. Presence of opiates in urine at screening 4. Other mental disorders than substance abuse/dependence considered to be severe and requiring treatment (dementia, severe depression with suicidal ideation, acute psychotic symptoms, schizophrenia - concurrent pharmacological treatment for depression, and mild psychotic symptoms such as paranoid ideation or other forms of milder delusions for which the patient has some degree of insight do not constitute exclusion criteria) 5. Ongoing treatment with benzodiazepines 6. Acute withdrawal symptoms at screening, irrespective of cause 7. Serious somatic disorder (e.g., cancer, moderate to severe hypertension, advanced atherosclerosis, liver cirrhosis, or other disorders considered to be a risk) 8. Known hypersensitivity to naltrexone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure of the study was abstinence from amphetamine use, as measured by negative amphetamine urine samples during 12 weeks of treatment (maximum of 24 samples). All missing urine samples were imputed as positive in the analysis. The primary analysis was carried out according to the Intention-To-Treat (ITT) approach. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes measures included the following: 1. Self reported use of amphetamine (as measured by Timeline Follow Back) 2. Self reported use of alcohol and other drugs of abuse (as measured by Timeline Follow Back) 3. Compliance to treatment, defined as: 3.1. 16/24 urine samples 3.2. Medication compliance, detected by the presence of 6-ß-naltrexol in the urine 3.3. Pill counts 4. Craving for amphetamine, measured by the amphetamine craving scale 5. Adverse events, monitored by the study physician and weekly self-report by patient All secondary outcome measures were evaluated on a weekly basis. | — |
Countries
Sweden
Outcome results
None listed