Pre-Release VIVITROL for Opioid Dependent Inmates

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Rhode Island Hospital
Sponsor:
Collaborators:
Alkermes, Inc.
Information provided by (Responsible Party):
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01563718
First received: March 23, 2012
Last updated: June 2, 2014
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Substance-Related Disorders
Drug: naltrexone for extended release injectable suspension
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: VIVITROL® (Naltrexone for Extended Release Injectable Suspension (XR-NTX)) for Opioid Dependent Inmates Released From Prison

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Proportion of opioid-free days [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: March 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRE-release XR-NTX 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 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563718

Contacts
Contact: Randall Hoskinson 401-444-0826 rhoskinson@lifespan.org

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Randall Hoskinson    401-444-0826    rhoskinson@lifespan.org   
Sponsors and Collaborators
Rhode Island Hospital
Alkermes, Inc.
Investigators
Principal Investigator: Peter D Friedmann, MD, MPH Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01563718     History of Changes
Other Study ID Numbers: RIH VIVITROL -01, 3R01DA024549-03S1
Study First Received: March 23, 2012
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014