Study Seeking Patients with Opioid Use Disorder

  • STATUS
    Recruiting
  • sponsor
    Alkermes
Updated on 25 March 2021

Summary

Study Seeking Patients with Opioid Use Disorder

Description

A Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of Naltrexone for use in Conjunction with Buprenorphine in Adults with Opioid Use Disorder Transitioning from Buprenorphine Maintenance Prior to First Dose of VIVITROL®

Details
Clinical Study IdentifierTX146952
SponsorAlkermes
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or Female 18 to 60 inclusive
BMI: 18-40 kg/m2
Opioid Use Disorder diagnosis for at least 6 months
History of at least 3 months of supervised BUP maintenance AND must be currently BUP-maintained by prescription
Must have government issued photo identification

Exclusion Criteria

Has used methadone within 30 days of starting study
Has used Naltrexone (oral or VIVITROL) within 3 months of starting study
Diagnosis of schizoaffective, bipolar or current, untreated major depression
More than 3 unsuccessful inpatient or outpatient medically assisted opioid detoxifications during subject’s lifetime
History of accidental drug overdose in the past 12 months
Significant suicidal ideation or behavior within the past year
Currently physiologically dependent on any psychoactive substance (except opioids, caffeine or tobacco)
History of seizures (exception: febrile seizures) or anticonvulsant therapy (during past 5 yrs)
Uncontrolled medical conditions (including uncontrolled hypertension and diabetes) that would interfere with safe participation in the study
Has participated in a clinical trial of an investigational drug within 3 months of starting study
Court mandated to receive treatment for Opioid Use Disorder
Clear my responses

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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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