Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
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ClinicalTrials.gov Identifier: NCT01180647 |
Recruitment Status
:
Completed
First Posted
: August 12, 2010
Results First Posted
: April 7, 2016
Last Update Posted
: April 7, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Opiate Dependence | Drug: Extended-Release Naltrexone Behavioral: Motivational Enhancement Counseling | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
---|---|
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.
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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
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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.
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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.
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- 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.
- 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.
- 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.
- 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.
- 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.
- Adverse Events and Serious Adverse Events [ Time Frame: Eight weeks post-release ]AEs and SAEs per standard definitions will be measured by self-report.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT01180647
United States, New York | |
New York University School of Medicine | |
New York, New York, United States, 10016 | |
New York City Department of Correction | |
New York, New York, United States, 11370 |
Principal Investigator: | Joshua D Lee, MD MSc | NYU School of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
First Posted: | August 12, 2010 Key Record Dates |
Results First Posted: | April 7, 2016 |
Last Update Posted: | April 7, 2016 |
Last Verified: | March 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Joshua D. Lee, 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:
Recurrence Opioid-Related Disorders Disease Attributes Pathologic Processes 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 Narcotic Antagonists |