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Completed

NCT Number: NCT01180647

Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail

This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.

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Key information

Conditions

Opiate Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

New York City Department of Correction, New York, United States

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About this study

This protocol randomizes persons soon-to-be-released from a large urban jail to treatment with extended-release naltrexone (XR-NTX), a full opioid antagonist that prevents the activity of heroin and other opioids. Investigators at NYUSOM and NYC DOHMH will recruit heroin dependent persons from NYC jails who are soon-to-be-released, not accessing opioid agonist pharmacotherapy, with lowered tolerance due to incarceration, and extremely likely to relapse and risk accidental overdose at release. All N=40 participants receive a two-session, individual psychosocial intervention, Motivational Interviewing. Half (n=20) will be randomized to pre-release treatment with XR-NTX. Immediately and one month following release, participants will be offered continued psychosocial and medication-assisted treatment (naltrexone, buprenorphine, or methadone) at Bellevue Hospital, including a second XR-NTX dose among XR-NTX arm participants. The primary outcome is relapse to sustained opioid use during the first 30 days post-release. We hypothesize an XR-NTX arm will report significantly lower rates of sustained opioid relapse following release.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults incarcerated in NYC jails with known release date
  • DSM-IV criteria for current opioid dependence
  • No current agonist (methadone, buprenorphine) treatment
  • Currently opioid free by history ('detoxed') and with a negative urine for all opioids
  • General good health as determined by complete medical interview and physical examination
  • Age 18-60 years.

Exclusion criteria

  • History of liver failure, cirrhosis, or recent liver function test levels greater than three times normal
  • Pregnancy, lactation, or planning conception
  • Active medical illness that might make participation hazardous
  • Untreated psychiatric disorder
  • History of allergic reaction to naltrexone, PLG (polylactide co-glycolide), carboxymethylcellulose, or any other components of the diluent.
  • Current chronic pain condition treated with opioids.

Treatment and study plan

Extended-Release Naltrexone

Drug

380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).

Other names: Vivitrol

Motivational Enhancement Counseling

Behavioral

The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.

Primary outcomes

  1. Post-Release Opioid Relapse

    Time frame: Four weeks post-release

    Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.

Secondary outcomes

  1. Participation in Community Drug Treatment Post-release

    Time frame: Four weeks post-release

    This secondary outcome tracks community drug treatment initiation four weeks post-release from jail. Measured by self-report community drug treatment initiation at week 4 study visit.

  2. Any Opioid Use Post-release

    Time frame: Four weeks post-release

    Counts of any opioid use, defined as self-reported ≥ 1 day of heroin or other opioid use as measured by the Timeline Follow-Back assessment during the first 4 weeks post-release.

  3. Injection Drug Use Post-release

    Time frame: Four weeks post-release

    This secondary outcome tracks any injection drug use and frequency of injection drug use in the four weeks following release from jail.

  4. Accidental Drug Overdose

    Time frame: Four weeks post-release

    Accidental drug overdose is defined as patient self-report of any event consistent with over-sedation or respiratory suppression following ingestion of alcohol, prescription, or illicit drugs.

  5. Adverse Events and Serious Adverse Events

    Time frame: Eight weeks post-release

    AEs and SAEs per standard definitions will be measured by self-report.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Alkermes, Inc.
  • New York City Department of Health and Mental Hygiene

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 12, 2010
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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