Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail - Full Text View

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:

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

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.


Enrollment:	34
Study Start Date:	May 2010
Study Completion Date:	July 2013
Primary Completion Date:	July 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

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: NCT01180647

Locations


United States, New York
New York City Department of Correction
New York, New York, United States, 11370
New York University School of Medicine
New York, New York, United States, 10016

Sponsors and Collaborators

New York University School of Medicine

Alkermes, Inc.

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 School of Medicine
ClinicalTrials.gov Identifier:	NCT01180647 History of Changes
Other Study ID Numbers:	NYU IRB Number: 09-0372
Study First Received:	August 10, 2010
Last Updated:	July 22, 2013
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:


Naltrexone Central Nervous System Agents Narcotic Antagonists Peripheral Nervous System Agents	Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015