Amphetamine dependence
Conditions
Interventions
Trade Name: Vivitrol
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intramuscular use
Sponsors
National Institute on Drug Abuse (NIDA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1) Aged 18 or above. 2) Primary diagnosis of current amphetamine dependence as defined by DSM-IV-TR with 10 or more days of amphetamine use in the past month. 3) Patient and clinician identify amphetamine dependence as the main problem. 4) Successfully complete 7-10 day assessment and study baseline measures at Vogur. 5) Abstinent from substances (alcohol, amphetamines, cannabinoid, cocaine, hallucinogens, opioids, benzodiazepines [unless used to treat alcohol withdrawal] for at least 7 days prior to receiving study drug or placebo. 6) Provision of telephone numbers/contacts of three or more people that are likely to know where can be located if unable to be contacted directly. 7) Successfully complete 7-10 day assessment and study baseline measures at Vogur. 8) Written informed consent. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1) Any liver test >5 times the top limit of normal. 2) Physiologically dependent on opioids or other substances (nicotine excepted) at time of study inclusion. 3) Suspected or known concomitant use of opioid analgesics, positive opioid urine drug test or positive naloxone challenge. 4) Schizophrenia, Bipolar I or other non-substance related psychotic disorder. 5) Severely depressed, suicidal or homicidal. 6) Dementia. 7) Inability to understand the informed consent. 8) Planning to move from the Reykjavík area or enter jail within next 6 months. 9) Medical problems that need immediate attention or that, in the opinion of the investigator, will interfere with ability to participate. 10) Likely to receive opioid analgesics in next 6 months associated with possible or scheduled surgery or procedure. 11) Known hypersensitivity to naltrexone, polyactide-co-glycolide (PLG), carboxymethylcellulose, or any other component of the diluents. 12) Female subjects who are pregnant or lactating, or of child bearing potential who are not using acceptable methods of birth control. 13) A body habitus that precludes use of the customized needle for intramuscular injection, based on clinical judgment. 14) Use of an investigational agent in the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To replicate previous findings showing that oral naltrexone prevents relapse to amphetamine addiction and extend these results using a 6 month course of extended release naltrexone (Vivitrol®) or placebo in treatment seeking amphetamine addicted patients in Iceland.;Secondary Objective: To compare the relative efficacy of extended release naltrexone (Vivitrol®) to (Vivitrol®) placebo on 1) reducing self reported amphetamine and other drug use, HIV risk, treatment dropout, craving for amphetamines, crimiminal activity, and symptoms of depression and 2) improving quality of life.;Primary end point(s): Proportion of amphetamine negative urines during weeks 1-24 of outpatient treatment. | — |
Countries
Iceland
Outcome results
None listed