Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
This study is currently recruiting participants.
Verified December 2012 by New York University School of Medicine
Sponsor:
New York University School of Medicine
Collaborator:
New York City Department of Health and Mental Hygiene
Information provided by (Responsible Party):
Joshua D. Lee, New York University
ClinicalTrials.gov Identifier:
NCT01180647
First received: August 10, 2010
Last updated: December 13, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Opiate Dependence |
Drug: Extended-Release Naltrexone Behavioral: Motivational Enhancement Counseling |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail |
Resource links provided by NLM:
Further study details as provided by New York University School of Medicine:
Primary Outcome Measures:
- Opioid Relapse [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]More than ten total days of opioid use in the four weeks following release from jail as tabulated by the Timeline Follow-Back assessment.
Secondary Outcome Measures:
- Opioid treatment retention/initiation [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]This secondary outcome tracks other opioid treatment retention and/or initiation during the four weeks post-release.
- Any opioid use [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]Rates of any opioid use, defined as continuous counts of both days and amount/day of heroin or other opioid use as measured by the Timeline Follow-Back assessment.
- Injection drug use [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]This secondary outcome tracks any injection drug use and frequency of IDU in the four weeks following release from jail.
- Accidental drug overdose [ Time Frame: Four weeks post-release ] [ Designated as safety issue: Yes ]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.
- Adverse Events and Serious Adverse Events [ Time Frame: Eight weeks post-release ] [ Designated as safety issue: Yes ]AEs and SAEs per standard definitions will be measured by self-report.
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Extended-release naltrexone (XR-NTX)
A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
|
Drug: Extended-Release Naltrexone
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 Name: Vivitrol
|
|
Placebo Comparator: Motivational Enhancement Counseling Only
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
|
Behavioral: Motivational Enhancement Counseling
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180647
Contacts
| Contact: Joshua D Lee, MD MSc | 212.263.4242 | joshua.lee@med.nyu.edu |
| Contact: Ryan D. McDonald, MA | 646-501-2541 | ryan.mcdonald@nyumc.org |
Locations
| United States, New York | |
| New York University School of Medicine | Active, not recruiting |
| New York, New York, United States, 10016 | |
| New York City Department of Correction | Recruiting |
| New York, New York, United States, 11370 | |
| Principal Investigator: Joshua D Lee, MD MSc | |
Sponsors and Collaborators
New York University School of Medicine
New York City Department of Health and Mental Hygiene
Investigators
| Principal Investigator: | Joshua D Lee, MD MSc | NYU School of Medicine |
More Information
No publications provided
| Responsible Party: | Joshua D. Lee, Assistant Professor, New York University |
| ClinicalTrials.gov Identifier: | NCT01180647 History of Changes |
| Other Study ID Numbers: | NYU IRB Number: 09-0372 |
| Study First Received: | August 10, 2010 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by New York University School of Medicine:
|
Extended-release naltrexone Prisoners Opioid addiction prevention Medication Treatment Alternatives Prevention of Relapse to Opioid Addiction |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders Naltrexone Analgesics, Opioid Narcotic Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 19, 2013