Amphetamine and opioid dependence (DSM-IV) Mental and Behavioural Disorders Opioid dependence
Conditions
Interventions
The naltrexone arm will receive Naltrexone depot implant (Prodotoxone) (containing 1000 mg of naltrexone), and the placebo arm will receive an identical-looking placebo implant. The patient receive on
Sponsors
National Institute for Health and Welfare (THL) (Finland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary diagnosis of current Amphetamine and Opioid Dependence (Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM-IV]), present for at least one year 2. Age between 18 and 50 years 3. Education as high school graduate or above 4. Negative urine toxicology and alcohol breath tests 5. Not currently on psychotropic medication 6. At least one relative willing to participate in treatment, monitor administration of medications, assist in follow-up, and provide outcome data 7. Stable address within St. Petersburg or nearest districts of Leningrad Region 8. Home telephone number at which the patient can be reached 9. Negative pregnancy test and use adequate contraception if of childbearing age 10. Willingness and ability to give informed consent and otherwise participate
Exclusion criteria
Exclusion criteria: 1. Clinically significant cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder, or seizure disorder 2. Advanced neurological, cardiovascular, renal, or hepatic disease 3. Active tuberculosis or current febrile illness 4. Acquired Immune Deficiency Syndrome (AIDS)-defining illness 5. Significant laboratory abnormality such as severe anaemia, unstable diabetes, or liver function tests greater than 3 x above normal 6. Pregnancy 7. Pending legal charges with potential impending incarceration 8. Concurrent participation in another treatment study 9. Concurrent treatment in another substance abuse program
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current information as of 22/12/2009: 1. Retention in the study 2. The proportion of urine samples, which are free of both amphetamine and opioids ("totally clean") during the follow-up. Missing samples are considered as amphetamine and opioid positive samples. 3. Improvement in Clinical Global Impression (CGI) during the follow-up Initial information at time of registration: 1. Amphetamine concentration in the urine samples and proportion of amphetamine-negative urine samples in each arm, obtained each week 2. Proportion of opioid-dependent patients (assessed with naloxone challenge test) in each arm, measured at at week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current information as of 22/12/2009: 1. The proportion of amphetamine free urine samples during the follow-up. Missing samples are considered as amphetamine positive samples. 2. The proportion of opioid free urine samples during the follow-up. Missing samples are considered as opioid positive samples. 3. Global Assessment of Functioning (GAF) 4. Number of days amphetamine used during follow-up 5. Adverse events Initial information at time of registration: Proportion of benzodiazepine-negative and cannabinoid-negative urine samples, obtained each week. | — |
Countries
Russian Federation
Outcome results
None listed