A Phase 3 interventional study of XR-NTX and XR-NTX+PN in Opioid Use Disorders, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by University of California, Los Angeles · Phase 3, Interventional, and Treatment
The aim of this trial is to assess the clinical utility, effectiveness, and cost implications of treatment for incarcerated offenders with opioid use disorders who are randomly assigned to one of three treatment conditions to include a depot formulation of naltrexone (XR-NTX, as Vivitrol®) only (XR-NTX), Vivitrol provided with sessions with a patient navigator (PN) XR-NTX+PN, and a drug education procedure (ETAU) before being released to the community. This trial will investigate whether effective medication therapy used in non-incarcerated populations will also be effective in incarcerated individuals. Empirical evidence demonstrates that starting treatment before release greatly increases the probability of successful outcome including reduced alcohol and drug use, increased employment rates, and reduced recidivism rates.
This randomized, open-label trial will examine the feasibility, efficacy, and net economic benefits of XR-NTX for opioid addiction delivered with and without a platform of PN provided for six months compared against an education (ETAU) condition. Before release from jail, participants in the XR_NTX and XR-NTX+PN conditions will receive their first Vivitrol injection (and those in the XR-NTX+PN condition will meet with a Patient Navigator) and will then be scheduled for medication management sessions twice monthly for months 1-3, with monthly injections in months 4-6. Participants in the XR-NTX+PN condition will meet with a PN who will provide behavioral assistance to overcome possible barriers to community outpatient treatment and will be provided with referrals for community treatment programs. Participants in the ETAU condition will receive education designed to reduce the likelihood of overdose on the same schedule as the XR-NTX and XR-NTX+PN groups.
Participants will be individuals who meet DSM-5 (Diagnostic and Statistical Manual-5) (via CIDI-2 (composite international diagnostic interview
)) criteria for opioid use disorders, are 18 years and older, who have been detoxified from opioids in the Metropolitan Detention Center in Albuquerque, New Mexico. This study will include only those participants for whom the study physician determines that possible treatment with the study drug is in the best interest, and informed consent will be obtained.
All participants will be scheduled for twice-monthly medical management and assessment appointments for the first three months of the 24-week post-release intervention phase, with monthly appointments for months 4-6. Eligible participants will be randomly assigned to treatment condition (XR-NTX, XR-NTX+PN, ETAU) in equal numbers. XR-NTX and XR-NTX+PN participants will undergo a naloxone challenge to ensure opioid abstinence at the time of Vivitrol induction. Those in the XR-NTX+PN condition will be provided with a PN (patient navigator) who will facilitate attendance at outpatient treatment programs as well as assist with other needs. The ETAU group will not receive any medication but will be scheduled for assessments and education on drugs of abuse, maintaining abstinence, and methods for avoiding overdoses on the same schedule as the other two groups. All groups will also be provided with referrals to community-based substance abuse treatment programs.
1,439 studies on the registry are indexed under Opioid-Related Disorders; 291 are open to participants now.
This study's enrollment of 151 is above the median of 62 across 1,145 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →University of California, Los Angeles is the lead sponsor of 1,167 studies on the registry; 192 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 69 (73%) have results posted.
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Exclusion Criteria:
50 participants will be randomized to the long-acting naltrexone condition (XR-NTX) which will include monthly injections of study drug.
Drug: XR-NTX
50 participants will be randomized to receive long-acting naltrexone (XR-NTX) and will be assigned to a patient navigator (PN).
Drug: XR-NTX · Behavioral: XR-NTX+PN
50 participants will be randomized to the drug-education/treatment-as-usual group.
Behavioral: ETAU
Monthly injections of XR-NTX will be administered to participants assigned to either the XR-NTX or XR-NTX+PN groups.
Also known as: long-acting naltrexone, Vivitrol
In addition to long-acting naltrexone (XR-NTX), participants assigned to the XR-NTX+PN condition will meet regularly with a patient navigator to assist in accessing psychosocial services when released from jail.
Also known as: Patient Navigator
Participants assigned to the ETAU group will receive drug education.
Also known as: Treatment-as-usual, Drug Education
Opioid Use
The primary objective is to compare outcomes of the three intervention groups, based on self-reports at 6-months post-intervention.
Time frame: 6 months
Opioid Use Disorder
Number of participants meeting DSM-5 OUD (opioid use disorder) criteria via modified CIDI-2 Substance Abuse Module
Time frame: 6 months
| Milestone | Vivitrol (XR-NTX) | XR-NTX+PN | ETAU |
|---|---|---|---|
| Started | 53 | 50 | 48 |
| Completed | 35 | 38 | 39 |
| Not completed | 18 | 12 | 9 |
The primary objective is to compare outcomes of the three intervention groups, based on self-reports at 6-months post-intervention.
| Participants | Vivitrol (XR-NTX) | XR-NTX+PN | ETAU |
|---|---|---|---|
| Opioid Use | 6 | 12 | 7 |
Number of participants meeting DSM-5 OUD (opioid use disorder) criteria via modified CIDI-2 Substance Abuse Module
| Participants | Vivitrol (XR-NTX) | XR-NTX+PN | ETAU |
|---|---|---|---|
| Opioid Use Disorder | 4 | 4 | 3 |
Collected over 6 months for participants in either of the two medication conditions.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vivitrol (XR-NTX) | 0/53 (0%) | 0/53 (0%) | 4/53 (7.5%) |
| XR-NTX+PN | 0/50 (0%) | 1/50 (2%) | 5/50 (10%) |
| ETAU | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| Event | Vivitrol (XR-NTX) | XR-NTX+PN | ETAU |
|---|---|---|---|
| Helpatobiliary disorderHepatobiliary disorders | 0/53 | 1/50 | 0/48 |
| Event | Vivitrol (XR-NTX) | XR-NTX+PN | ETAU |
|---|---|---|---|
| Pain at injection siteGeneral disorders | 2/53 | 4/50 | 0/48 |
| Precipitated withdrawalInjury, poisoning and procedural complications | 1/53 | 1/50 | 0/48 |
| photophobiaEye disorders | 1/53 | 0/50 | 0/48 |
| Blurred visionEye disorders | 1/53 | 0/50 | 0/48 |
16 participants were deemed ineligible because they were directly transferred from jail to prison.
| Age, Continuous(years) | Vivitrol (XR-NTX) | XR-NTX+PN | ETAU | Total |
|---|---|---|---|---|
| Mean | 31 ± 9.5 | 34 ± 8.8 | 33 ± 9.7 | 33 ± 9.4 |
| Sex: Female, Male(Participants) | Vivitrol (XR-NTX) | XR-NTX+PN | ETAU | Total |
|---|---|---|---|---|
| Female | 11 | 12 | 14 | 37 |
| Male | 35 | 33 | 30 | 98 |
| Race (NIH/OMB)(Participants) | Vivitrol (XR-NTX) | XR-NTX+PN | ETAU | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 4 | 5 | 4 | 13 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 | 12 |
| White | 36 | 32 | 26 | 94 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 5 | 8 | 16 |
| Region of Enrollment(participants) | Vivitrol (XR-NTX) | XR-NTX+PN | ETAU | Total |
|---|---|---|---|---|
| United States | 46 | 45 | 44 | 135 |
Documents are hosted by the registry — open the source record to download them.
The record gives a start of Jun 2015, a primary completion of Dec 2018 and a completion of May 2019. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2020, 1 year 1 month after primary completion.
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Studies of the drug tested here: Naltrexone
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