Naltrexone is a medication that has been shown to help prevent relapse to opioid addiction
and it has been reported to be clinically effective in parolee populations although it is
rarely used. Recently a depot formulation with one-month duration has received FDA approval
for the treatment of alcoholism and opiate dependence. This means that rather than having to
take medication daily, individuals can receive one injection that lasts for approximately 30
days. The purpose of this study is to determine whether this monthly injection of naltrexone
is practical and useful in the prevention of relapse to opioids and re-incarceration when
administered to inmates prior to release from prison. The investigators will also monitor HIV
risk behaviors to determine whether the intervention reduces risky behaviors associated with
intravenous drug abuse and the spread of viruses such as HIV and hepatitis C. Volunteers will
be randomized to receive an injection of depot naltrexone prior to release from prison or to
contact study personnel in the community following release. Participants assigned to receive
naltrexone in prison will receive 1 injection in prison, and 5 additional monthly injections
for 5 months upon release. Participants assigned to contact study personnel upon release will
receive all 6 injections in the community at RIH after their release from the ACI. Patients
in both groups will be given identical follow up monthly for six months including measures of
opiate use by self-report, and urine tests. An additional scheduled urine test will take
place each month between monthly visits. There will also be a 12-month follow-up period for
participants in both groups, which will consist of 2 visits, spaced 6 months apart, meaning
that participants will be enrolled in the study for a total of about 18 months. All
participants will be asked to complete brief questionnaires at follow-up visits to assess
things such as services received, drug use, and depression.
Phase:
Phase 4
Details
Lead Sponsor:
Rhode Island Hospital
Collaborators:
Alkermes, Inc. National Institute on Drug Abuse (NIDA)