Study for Treatment-Seeking Participants With Opioid Use Disorder

  • STATUS
    Recruiting
  • sponsor
    Reckitt Benckiser
Updated on 23 November 2020

Summary

Study for Treatment-Seeking Participants With Opioid Use Disorder

Description

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

For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT02357901?term=RB-US-13-0001&rank=1 or segaltrials.com

Details
Clinical Study IdentifierTX140953
SponsorReckitt Benckiser
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

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 maintenance treatment for opioid use disorder
Is an appropriate candidate for opioid partial-agonist maintenance treatment in the opinion of the Investigator or medically responsible physician
Body mass index (BMI) of ≥ 18.0 to ≤ 35.0 kg/m^2

Exclusion Criteria

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 30 days prior to providing written informed consent
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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