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

Opiate Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180647
• Other study ID #: NYU IRB Number: 09-0372
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2010
• Last updated: July 22, 2013
• Start date: May 2010
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate Dependence

Intervention

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).

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.

Locations

Country	Name	City	State
United States	New York City Department of Correction	New York	New York
United States	New York University School of Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University School of Medicine	Alkermes, Inc., New York City Department of Health and Mental Hygiene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Relapse	More than ten total days of opioid use in the four weeks following release from jail as tabulated by the Timeline Follow-Back assessment.	Four weeks post-release	No
Secondary	Opioid treatment retention/initiation	This secondary outcome tracks other opioid treatment retention and/or initiation during the four weeks post-release.	Four weeks post-release	No
Secondary	Any opioid use	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.	Four weeks post-release	No
Secondary	Injection drug use	This secondary outcome tracks any injection drug use and frequency of IDU in the four weeks following release from jail.	Four weeks post-release	No
Secondary	Accidental drug overdose	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.	Four weeks post-release	Yes
Secondary	Adverse Events and Serious Adverse Events	AEs and SAEs per standard definitions will be measured by self-report.	Eight weeks post-release	Yes