- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02110264
Injectable Pharmacotherapy for Opioid Use Disorders (IPOD) (IPOD)
Depot Pharmacotherapies for Opioid-Dependent Offenders: Outcomes and Costs
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87106
- University of New Mexico Center on Alcoholism, Substance Abuse and Addictions
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be at least 18 years of age or older,
- Meet criteria for DSM-5 opioid use disorders,
- Be detained for at least 48 hours,
- Have an expected release date within one year,
- Plan to reside in area after release.
Exclusion Criteria:
- Have a medical (e.g., liver failure, congestive heart failure) or psychiatric condition (e.g., suicidal ideation, psychosis) that would make participation unsafe in the judgment of the medical staff or the PI,
- Have current or chronic pain or have plans to undergo pain treatment/therapy,
- Have known sensitivity to naltrexone or naloxone,
- Have participated in an investigational drug study within the past 30 days prior to screening,
- Be a nursing or pregnant female, or not agree to use a medically acceptable form of birth control such as oral contraceptives, barrier (diaphragm or condom), levonorgestrel implant, intra-uterine progesterone contraceptives system, medroxyprogesterone acetate contraceptive injection, or complete abstinence. Females who become pregnant during the course of the study will be withdrawn from the study and, if requested, will be provided with referrals for drug treatment and/or medical care,
- Have any pending legal action that could prohibit continued participation for the 24-week intervention period of the study, such as legal proceedings that could possibly result in incarceration,
- Have a current pattern of alcohol, benzodiazepine, or other depressant or sedative hypnotic use, as determined by the study physician which would preclude safe participation in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vivitrol (XR-NTX)
50 participants will be randomized to the long-acting naltrexone condition (XR-NTX) which will include monthly injections of study drug.
|
Monthly injections of XR-NTX will be administered to participants assigned to either the XR-NTX or XR-NTX+PN groups.
Other Names:
|
Experimental: XR-NTX+PN
50 participants will be randomized to receive long-acting naltrexone (XR-NTX) and will be assigned to a patient navigator (PN).
|
Monthly injections of XR-NTX will be administered to participants assigned to either the XR-NTX or XR-NTX+PN groups.
Other Names:
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.
Other Names:
|
Active Comparator: ETAU
50 participants will be randomized to the drug-education/treatment-as-usual group.
|
Participants assigned to the ETAU group will receive drug education.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Use
Time Frame: 6 months
|
The primary objective is to compare outcomes of the three intervention groups, based on self-reports at 6-months post-intervention.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Use Disorder
Time Frame: 6 months
|
Number of participants meeting DSM-5 OUD (opioid use disorder) criteria via modified CIDI-2 Substance Abuse Module
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David Farabee, PhD, University of California, Los Angeles
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA034743
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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