Clinical trial NCT02110264: Injectable Pharmacotherapy for Opioid Use Disorders (IPOD)
Official title: Depot Pharmacotherapies for Opioid-Dependent Offenders: Outcomes and Costs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid Use Disorders
Keywords: Opioid Use
Incarceration
Vivitrol
Patient Navigator
Drug Education
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Alkermes, Inc.
First posted: 2014-04-10
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Be at least 18 years of age or older,
2. Meet criteria for DSM-5 opioid use disorders,
3. Be detained for at least 48 hours,
4. Have an expected release date within one year,
5. Plan to reside in area after release.

Exclusion Criteria:

1. 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,
2. Have current or chronic pain or have plans to undergo pain treatment/therapy,
3. Have known sensitivity to naltrexone or naloxone,
4. Have participated in an investigational drug study within the past 30 days prior to screening,
5. 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,
6. 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,
7. 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.

Primary outcomes:
measure: Opioid Use
timeFrame: 6 months
Secondary outcomes:
measure: Opioid Use Disorder
timeFrame: 6 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Center on Alcoholism, Substance Abuse and Addictions
state: New Mexico
Study officials:
affiliation: University of California, Los Angeles
name: David Farabee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farabee D, Hillhouse M, Condon T, McCrady B, McCollister K, Ling W. Injectable pharmacotherapy for opioid use disorders (IPOD). Contemp Clin Trials. 2016 Jul;49:70-7. doi: 10.1016/j.cct.2016.06.003. Epub 2016 Jun 6.