Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland
Condition: Amphetamine Dependence
MeSH terms: Amphetamine-Related Disorders
Intervention: VIVITROL injection and VIVITROL Placebo Injection , 24 weeks
Intervention description: Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: amphetamine dependence; amphetamine injection; VIVITROL/VIVITROL placebo; amphetamine craving

Summary:

      Until positive results were found with oral naltrexone, no medication has been effective
      against amphetamine dependence. The primary aim of this pilot study is to replicate the
      findings of the Swedish team that showed oral Naltrexone prevented relapse to amphetamine
      addiction and to extend their results by randomizing treatment-seeking amphetamine addicted
      patients to a 6 month course of VIVITROL (naltrexone for extended-release injectable
      suspension) or VIVITROL placebo. Patients in each group will receive drug counseling.
      VIVITROL is administered monthly and may be a better test of efficacy than tablets that must
      be taken daily.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 or above;

          2. Diagnosis of amphetamine dependence as defined by DSM-IV-TR with 10 or more days of
             amphetamine use in the past month, and patient and clinician identify amphetamine
             dependence as the main problem;

          3. 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;

          4. 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;

          5. Successfully complete 7-10 day assessment and study baseline measures at Vogur

        Exclusion Criteria:

          1. Any liver test >5 times the top limit of normal; Physiologically dependent on opioids
             or other substances (nicotine excepted) at time of admission to Vogur;

          2. Suspected or known concomitant use of opioid analgesics, positive opioid urine drug
             test or positive naloxone challenge:

          3. Schizophrenia, Bipolar I or other non-substance related psychotic disorder; Severely
             depressed, suicidal or homicidal: Dementia: Inability to understand the informed
             consent;

          4. Planning to move from the Reykjavík area or enter jail within the next 12 months;

          5. Likely to receive opioid analgesics in next 6 months associated with possible or
             scheduled surgery or procedure;

          6. Known hypersensitivity to naltrexone, polyactide-co-glycolide (PLG);
             carboxymethylcellulose, or any other component of the diluent;

          7. Female subjects who are pregnant or lactating, or of child bearing potential who are
             not using acceptable methods of birth control;

          8. A body habitus that precludes use of the customized needle for intramuscular
             injection, based on clinical judgment;

          9. Use of an investigational agent in the past 30 days