Status:
COMPLETED
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
Lead Sponsor:
Indivior Inc.
Conditions:
Opioid-related Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/na...
Detailed Description
Buprenorphine sublingual and buccal soluble films are being developed to be used for the same indication and over the same buprenorphine dose range as Subutex and Suboxone sublingual tablets in the tr...
Eligibility Criteria
Inclusion
- Subject must:
- Provide written informed consent.
- Have a Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of opioid dependence.
- Be male or female, 18 to 65 years of age, inclusive.
- If female, have a negative pregnancy test during screening and agree to use an acceptable method of birth control.
Exclusion
- Subjects must not:
- Have participated in an experimental drug or device study within the last 30 days.
- Be currently (past 30 days from start of screening) engaged in opioid agonist, opioid partial agonist, or opioid antagonist treatment.
- If female, be breast feeding or lactating.
- Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study.
- Have any clinically significant non-substance use psychiatric disorder (e.g., schizophrenia).
- Have current suicidal ideation.
- Have a Mini Mental Status Exam score less than 24.
- Have physical dependence on alcohol.
- Have physical dependence on sedative-hypnotics.
- Have active aphthous stomatitis.
- Have active oral herpes.
- Need on-going prescription medications that interact with the P450 3A4 (a member of the cytochrome P450 superfamily of enzymes) system.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00637000
Start Date
March 1 2008
End Date
September 1 2008
Last Update
June 5 2017
Active Locations (1)
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1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224