Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine

Completed · Phase 3 · Has a placebo group

Conditions studied: Opioid Dependence, Opioid Related Disorders

In brief

This is a randomized, double-blind, placebo controlled, multicenter study in male and female participants who are seeking treatment for opioid use disorder.

Key facts

Study ID

NCT02357901

Run by

Indivior Inc.

People needed

665

Starts

2015-01-28

Expected to finish

2016-04-29

Last updated by the study team

2018-02-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for moderate or severe opioid use disorder
• By medical history has met DSM-5 criteria for moderate or severe opioid use disorder for the 3 months immediately prior to signing the informed consent form
• Is seeking medication-assisted treatment for opioid use disorder
• Is an appropriate candidate for opioid partial-agonist medication-assisted treatment in the opinion of the investigator or medically responsible physician
• Body mass index (BMI) of ≥ 18.0 to ≤ 35.0 kg/m\^2

You may not qualify if…

• Current diagnosis other than opioid use disorder requiring chronic opioid treatment
• Current substance use disorder as defined by DSM-5 criteria with regard to any substances other than opioids, cocaine, cannabis, tobacco, or alcohol.
• Positive urine drug screen (UDS) result at screening for cocaine or cannabis AND meets DSM-5 criteria for either moderate or severe cocaine or cannabis use disorder, respectively
• Meets DSM-5 criteria for moderate or severe alcohol use disorder
• Received medication-assisted treatment for opioid use disorder (e.g., methadone, buprenorphine) in the 90 days prior to providing written informed consent

Where it is running

• Haleyville Clinical Research — Haleyville, Alabama, United States
• Boyett Health Services — Hamilton, Alabama, United States
• Woodland International Research Group — Little Rock, Arkansas, United States
• Collaborative Neuroscience Network — Garden Grove, California, United States
• Behavioral Research Specialists — Glendale, California, United States
• Synergy Clinical Research Center — National City, California, United States
• North County Clinical Research — Oceanside, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Care Practice — San Francisco, California, United States
• Southern California Research — Thousand Oaks, California, United States
• Amit Vijapura — Jacksonville, Florida, United States
• Meridien Research — Lakeland, Florida, United States
• Innovative Clinical Research — Lauderhill, Florida, United States
• Florida Clinical Research Center — Maitland, Florida, United States
• Try Research — Maitland, Florida, United States
• Scientific Clinical Research — North Miami, Florida, United States
• Research Centers of America — Oakland Park, Florida, United States
• Behavioral Health Care Associates — Schaumburg, Illinois, United States
• Phoenix Medical Research — Prairie Village, Kansas, United States
• Louisiana Research Associates — New Orleans, Louisiana, United States
• Louisiana Clinical Research — Shreveport, Louisiana, United States
• Stanley Street Treatment and Resources — Fall River, Massachusetts, United States
• Adams Clinical Trials — Watertown, Massachusetts, United States
• Precise Research Centers, Inc. — Flowood, Mississippi, United States
• St Louis Clinical Trials — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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