Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

Condition(s) targeted: Amphetamine Dependence

Intervention: VIVITROL/VIVITROL placebo injection, 24 weeks (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Helen Pettinati, Ph.D, Principal Investigator, Affiliation: University of Pennsylvania
George Woody, M.D., Principal Investigator, Affiliation: University of Pennsylvania

Overall contact:
Thorarinn Tyrfingsson, M.D., Phone: +354 530 7670, Email: thorarinn@saa.is

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.

Official title: Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Between group proportions of Amphetamine negative urine tests.

Secondary outcome: Time to relapse: HIV risk behavior; Treatment retention; Amphetamine craving; Use of amphetamine and other drugs; Criminal activity; Depression; Quality of Life

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 18 or above;

- 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;

- 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;

- 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;

- Successfully complete 7-10 day assessment and study baseline measures at Vogur

Exclusion Criteria:

- 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;

- Suspected or known concomitant use of opioid analgesics, positive opioid urine drug

test or positive naloxone challenge:

- Schizophrenia, Bipolar I or other non-substance related psychotic disorder; Severely

depressed, suicidal or homicidal: Dementia: Inability to understand the informed consent;

- Planning to move from the Reykjavík area or enter jail within the next 12 months;

- Likely to receive opioid analgesics in next 6 months associated with possible or

scheduled surgery or procedure;

- Known hypersensitivity to naltrexone, polyactide-co-glycolide (PLG);

carboxymethylcellulose, or any other component of the diluent;

- Female subjects who are pregnant or lactating, or of child bearing potential who are

not using acceptable methods of birth control;

- A body habitus that precludes use of the customized needle for intramuscular

injection, based on clinical judgment;

- Use of an investigational agent in the past 30 days

Thorarinn Tyrfingsson, M.D., Phone: +354 530 7670, Email: thorarinn@saa.is

SAA National Center of Addiction Medicine, Vogur Hospital, Storhofoi 45, 110 Reykjavik, Iceland; Not yet recruiting
Igunn Hansdottir, Ph.D., Phone: +354 530 7602, Email: ingunnh@saa.is
Valgerdur Runarsdottir, Phone: +354 530 7655, Email: valgerdurr@saa.is
Thorarinn Tyfingsson, M.D., Principal Investigator
Valgerdur Runarsdottir, Sub-Investigator

Starting date: May 2010
Last updated: April 9, 2010