Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone

1.2.1 Primary and Secondary Outcome Measures

Primary outcomes are:

• Opiate positive urine tests; 2) HIV injecting risk.

Secondary outcomes are:

• Time to relapse; 2) HIV sex risk; 3) Proportion of appointments kept; 6) Psychiatric symptoms; 7) Opioid craving; 8) Self-reported drug use; 9) Money spent for drugs; 10) Employment; 11) Arrests; 12) Overall adjustment; 12) Adverse events.

Hypotheses are that:

• Primary outcomes will significantly favor the 48-week Vivitrol condition;
• Five or more secondary outcomes will favor the 48-week condition; none will favor the 24-week condition.

Inclusion criteria

• HIV-negative men and women 18 years of age or older who meet the Diagnostic and Statistical Manual of Mental Disorders 4th edition-Text Revision (DSM- IV-TR) criteria for opioid dependence
• Must be voluntarily seeking treatment for opioid dependence, with injection heroin as the drug and administration route of choice
• Must report sharing injection equipment during the past year
• Must have successfully completed inpatient detoxification at the Federal Medical Research Center for Psychiatry and Narcology (FMRCPN)
• Must have no current evidence of physiologic dependence
• Must have a stable address in Moscow with a telephone number where they can be reached
• If female, must have a negative pregnancy test and use of medically acceptable contraception if of childbearing age
• Must be able to provide informed consent as judged by the ability to read the consent and correctly answer 9 out of 10 questions about the study on a quiz

Exclusion criteria

• No current condition of psychosis (schizophrenia,paranoid disorder, mania)
• No history of major psychiatric disorders such as Schizophrenia, Major Depression with suicidal attempts, Bipolar I, uncontrolled epilepsy or other seizure disorder
• No current dependence (within the past year) to drugs other than prescription opiates or heroin, caffeine, marijuana, or nicotine based on the Diagnostic and Statistical Manual of Mental Disorders-Text Revision (DSM -IV-TR) criteria
• No current alcohol dependence or alcohol use disorder that would preclude successful completion of study procedures
• No current suicidal or homicidal ideation requiring immediate attention as determined at baseline assessment
• No cognitive impairment with inability to read and understand the consent
• No significant laboratory abnormality such as haemoglobin <10, hepatic transaminase levels >3 times upper limit of normal or serum creatinine that is >1.5 times upper limit of normal
• No legal charges with impending incarceration
• No concurrent participation in another treatment study
• Cannot be scheduled for surgery or be likely to require opioids for pain control in next 2 years
• Not currently taking naltrexone or currently receiving other treatment (pharmacological or behavioral) for drug dependence or currently receiving psychoactive medication
• Cannot have had receipt of any approved or investigational depot product administered into the gluteal muscle within 6 months before screening
• Cannot be on any excluded medication at screening or be anticipating the use of an excluded medication during the study period
• Cannot have participated in a clinical trial of a pharmacological agent within 30 days prior to screening