Pre-Release VIVITROL for Opioid Dependent Inmates
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | March 2012 |
| End Date: | August 2015 |
VIVITROL® (Naltrexone for Extended Release Injectable Suspension (XR-NTX)) for Opioid Dependent Inmates Released From Prison
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.
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.
Inclusion Criteria:
1. Incarcerated adults with known release date.
2. Meet DSM-IV criteria for current (and/or prior to incarceration) opioid dependence.
3. Not interested in agonist (methadone, buprenorphine) treatment.
4. Currently opioid free by history ('detoxed'), with negative urine for all opioids and
no sign of opiate withdrawal after IV (or IM if no available venous access) injection
of 0.8 mg naloxone.
5. Good health by medical history, physical examination and laboratory tests.
6. Age older than 18.
7. Understands and signs a consent form.
8. Able to speak and understand English.
9. Females: not pregnant (urine hCG negative at baseline and prior to each injection),
not planning conception; and planning appropriate contraception if sexually active.
Exclusion Criteria:
1. Current drug or alcohol dependence requiring long term residential treatment that
would interfere with outpatient study participation. Dependence on substances that
commonly co-occur with opioid dependence (e.g. cocaine, cannabis, alcohol) that do
not rise to this level of severity will not be exclusionary in order to achieve a
maximally representative sample.
2. Liver failure and/or liver function test levels greater than three times normal.
3. Pregnancy, lactation, or failure to use adequate contraceptive methods;
4. Active medical illness that might make participation hazardous, e.g. untreated
hypertension, hepatitis with AST or ALT > 3 times upper limit of normal, unstable
diabetes or heart disease. Adequately treated medical conditions are acceptable.
5. Untreated psychiatric disorder that might make participation hazardous, e.g.
untreated psychosis, bipolar disorder with mania, significant suicide risk.
Adequately treated psychiatric disorders and appropriate psychotropic medications
would be allowed.
6. History of allergic reaction to naltrexone;
7. Current chronic pain diagnosis for which opioids are required for pain relief.
8. Obesity (BMI of 40 or greater) to reduce the likelihood of injection site reaction.
9. Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or
polylactide-co-polymers (PLG) or any other components of the diluents.
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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