Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
Opioid-related Disorders
About this trial
This is an interventional treatment trial for Opioid-related Disorders focused on measuring Opioid dependence, Opioid withdrawal symptoms
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Sites / Locations
- Johns Hopkins University School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Buprenorphine soluble film
Buprenorphine/naloxone soluble film
Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours. Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.
Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours. Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.