Pre-Release VIVITROL for Opioid Dependent Inmates
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ClinicalTrials.gov Identifier: NCT01563718 |
Recruitment Status :
Completed
First Posted : March 27, 2012
Last Update Posted : October 22, 2015
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Condition or disease | Intervention/treatment | Phase |
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Substance-Related Disorders | Drug: naltrexone for extended release injectable suspension | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | VIVITROL® (Naltrexone for Extended Release Injectable Suspension (XR-NTX)) for Opioid Dependent Inmates Released From Prison |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | August 2015 |
Arm | Intervention/treatment |
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Experimental: PRE-release XR-NTX
Participants randomly assigned to the pre-release condition will receive one injection of XR-NTX 1-2 weeks prior to prison release plus up to five additional injections of XR-NTX in the community after release
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Drug: naltrexone for extended release injectable suspension
VIVITROL (naltrexone for extended-release injectable suspension) is supplied as a microsphere formulation of naltrexone for suspension, at a dose of 4cc (380mg of naltrexone base), administered by intramuscular injection to the buttocks (alternating sides monthly) for six months.
Other Name: VIVITROL |
Active Comparator: POST-release XR-NTX
Participant randomly assigned to the post-release group will be referred to Rhode Island Hospital to receive up to six injections of XR-NTX immediately after release from prison
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Drug: naltrexone for extended release injectable suspension
VIVITROL (naltrexone for extended-release injectable suspension) is supplied as a microsphere formulation of naltrexone for suspension, at a dose of 4cc (380mg of naltrexone base), administered by intramuscular injection to the buttocks (alternating sides monthly) for six months.
Other Name: VIVITROL |
- Proportion of opioid-free days [ Time Frame: 18 months ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Incarcerated adults with known release date.
- Meet DSM-IV criteria for current (and/or prior to incarceration) opioid dependence.
- Not interested in agonist (methadone, buprenorphine) treatment.
- 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.
- Good health by medical history, physical examination and laboratory tests.
- Age older than 18.
- Understands and signs a consent form.
- Able to speak and understand English.
- 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:
- 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.
- Liver failure and/or liver function test levels greater than three times normal.
- Pregnancy, lactation, or failure to use adequate contraceptive methods;
- 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.
- 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.
- History of allergic reaction to naltrexone;
- Current chronic pain diagnosis for which opioids are required for pain relief.
- Obesity (BMI of 40 or greater) to reduce the likelihood of injection site reaction.
- Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-polymers (PLG) or any other components of the diluents.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563718
United States, Rhode Island | |
Rhode Island Hospital | |
Providence, Rhode Island, United States, 02903 |
Principal Investigator: | Peter D Friedmann, MD, MPH | Rhode Island Hospital |
Responsible Party: | Rhode Island Hospital |
ClinicalTrials.gov Identifier: | NCT01563718 |
Other Study ID Numbers: |
RIH VIVITROL -01 3R01DA024549-03S1 ( U.S. NIH Grant/Contract ) |
First Posted: | March 27, 2012 Key Record Dates |
Last Update Posted: | October 22, 2015 |
Last Verified: | October 2015 |
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Naltrexone Alcohol Deterrents |
Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |