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Long-acting Naltrexone for Pre-release Prisoners

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ClinicalTrials.gov Identifier: NCT02867124
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Friends Research Institute, Inc.

Brief Summary:
This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication.Following initial screening, informed consent, and medical examination, pre-release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient's place of residence.

Condition or disease Intervention/treatment Phase
Opiate Addiction Drug: XR-NTX Other: place of residence Other: opioid treatment program Phase 3

Detailed Description:
Disorders involving opioid use are a severe problem among jail and prison inmates. Inmates in the US, Canada, Australia, and many European and Asian nations have disproportionately higher rates of opioid use disorders than their general populations. Scarce resources are provided for corrections-based substance use treatment in many nations, and many inmates with OUDs remain untreated. The use of long-acting, injectable naltrexone (XR-NTX) may be a promising form of treatment for pre-release prisoners. Naltrexone blocks the intoxicating and reinforcing effects of opioids, but has no opioid-like effects. This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication. Project implementation will occur at five pre-release prisons under the jurisdiction of the Maryland Department of Public Safety and Correctional Services (MDPSCS): 1) Metropolitan Transition Center (MTC) for men; 2) Baltimore Pre-Release Unit (BPRU) for men; 3) Jessup Pre-Release Unit (JPRU) for men; 4) Baltimore City Correctional Center (BCCC) and 5) Maryland Correctional Institution (MCI) for Women. Following initial screening, informed consent, and medical examination, pre-release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient's place of residence. All participants will be confirmed opiate-free by urine test and negative naloxone and oral naltrexone tests, and evaluated monthly for seven months and 12 months after release from prison. The proposed study has two specific aims: Aim1. To compare the two study conditions in terms of: a) XR-NTX treatment adherence; b) opioid use; c) criminal activity; d) re-arrest; e) re-incarceration; and f) HIV risk-behaviors (i. needle use; ii. risky sexual behaviors). Aim 2. To determine if the number of months of post-release XR-NTX treatment is related to outcome (a-f above), and if so, is there a point at which XR-NTX v. Non-XR-NTX equilibrates? This would help determine the number of injections, important because of XR-NTX cost. Many individuals in the criminal justice system drop out of treatment and therefore increasing ways to improve adherence by attempting to: 1) expand capacity; and 2) implement access by providing treatment at their place of residence may positively impact outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-acting Naltrexone for Pre-release Prisoners: A Randomized Trial of Mobile Treatment
Actual Study Start Date : January 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vivitrol at place of residence
One injection of long-acting naltrexone (XR-NTX) in prison, followed by 6 monthly injections post-release at the participants's place of residence utilizing mobile medical treatment
Drug: XR-NTX
Vivitrol
Other Name: long-acting naltrexone

Other: place of residence
One injection of XR-NTX in prison, followed by 6 monthly injections post-release at place of residence
Other Name: residence

Active Comparator: Vivitrol at opioid treatment program
One injection of long-acting naltrexone (XR-NTX) in prison, followed by 6 monthly injections post-release at a community opioid treatment program.
Drug: XR-NTX
Vivitrol
Other Name: long-acting naltrexone

Other: opioid treatment program
One injection of XR-NTX in prison, followed by 6 monthly injections post-release at a community opioid treatment program
Other Name: OTP




Primary Outcome Measures :
  1. treatment adherence [ Time Frame: six months ]
    XR-NTX+ MMTx vs. XR-NTX-OTx following release from prison

  2. Any illicit opioid used [ Time Frame: 1,2,3,4,5,6,7 and 12-months following release from prison ]
    defined as continuous counts of days and urine toxicologies for heroin or other illicit opioid

  3. re-arrest [ Time Frame: 12-months following release from prison ]
    Re-arrest will be assessed using self-report on the Arrests and Days Incarcerated form and from Official Records received from the Maryland Department of Public Safety and Correctional Services

  4. re-incarceration [ Time Frame: 12-months following release from prison ]
    Re-incarceration will be assessed using self-report on the Arrests and Days Incarcerated form and from Official Records received from the Maryland Department of Public Safety and Correctional Services

  5. criminal activity [ Time Frame: 1,2,3,4,5,6,7 and 12-months following release from prison ]
    Self-reported crime days will be defined as continuous counts of days collected from the Addiction Severity Index and Time Line Follow-Back

  6. Injection drug use and HIV sexual risk factors [ Time Frame: 6 and 12-months following release from prison ]
    Injection drug use and HIV sexual risk factors will be measured using the Risk Assessment Battery.


Secondary Outcome Measures :
  1. Treatment Group Equilibration [ Time Frame: 6 and 12-months following release from prison ]
    time point at which the trajectories for use in the two treatment groups cross



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult male or female inmate at MTC, BPRU, JPRU, BCCC, or MCIW and be eligible for release within 30 days
  • History of opiate disorder [meeting DSM-V criteria of dependence at the time of incarceration]
  • Suitability for XR-NTX treatment as determined by medical evaluation
  • Currently opioid-free by history, with negative urine for all opioids and no signs of opiate withdrawal
  • Willingness to enroll in XR-NTX treatment in prison [not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release]
  • Planning to live in Baltimore City or County.
  • Inmates not meeting the opioid-dependence criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration

Exclusion Criteria:

  • Liver function test levels greater than three times normal
  • Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease). Adequately treated medical conditions are acceptable
  • Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania). Adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed
  • History of allergic reaction to XR-NTX
  • Current chronic pain diagnosis for which opioids are prescribed
  • Creatinine above normal limits
  • Pregnancy (for women)
  • Breast-feeding (for women)
  • Suicidal ideation (within the past 6-months)
  • Body Mass Index (BMI) > 40
  • Unadjudicated charges that may result in transfer to another facility and/or additional prison time.

Information from the National Library of Medicine

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): NCT02867124


Contacts
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Contact: Michael S Gordon, DPA 410-837-3977 ext 251 mgordon@friendsresearch.org

Locations
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United States, Maryland
Maryland Department of Public Safety and Correctional Services Recruiting
Towson, Maryland, United States, 21286
Contact: Sandra Davis-Hart       sandra.davis-hart@maryland.gov   
Sponsors and Collaborators
Friends Research Institute, Inc.
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Michael S Gordon, DPA Friends Research Institute, Inc.
  Study Documents (Full-Text)

Documents provided by Friends Research Institute, Inc.:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02867124     History of Changes
Other Study ID Numbers: FriendsResearch
R01DA040636 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Naltrexone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents
Narcotic Antagonists