Injectable Pharmacotherapy for Opioid Use Disorders (IPOD)

Completed · Phase 3

Conditions studied: Opioid Use Disorders

In brief

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.

Key facts

Study ID

NCT02110264

Run by

University of California, Los Angeles

People needed

151

Starts

2015-06-01

Expected to finish

2019-05-01

Last updated by the study team

2020-01-22

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 Females who become pregnant during the course of the study will be withdrawn from the study and, if requested, will be provided with referrals for drug treatment and/or medical care,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.

Where it is running

• University of New Mexico Center on Alcoholism, Substance Abuse and Addictions — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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