Study to Assess OX219 (Buprenorphine/Naloxone) for the Induction of Treatment of Opioid Dependence



Status:Completed
Conditions:Psychiatric, Gastrointestinal
Therapuetic Areas:Gastroenterology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:11/30/2013
Start Date:June 2013
End Date:December 2013
Contact:Peter Hjelmström
Email:peter.hjelmstrom@orexo.com
Phone:+4618 7808800

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A Randomized, Blinded, Active-controlled Non-inferiority Study of the Efficacy and Safety of OX219 for the Induction of Treatment of Opioid Dependence


The purpose of the study is to assess how effective starting buprenorphine treatment of
opioid dependence directly on the buprenorphine/naloxone combination OX219 is, compared to
starting treatment on buprenorphine only. The hypothesis is that starting directly on OX219
works equally well (e.g. not significantly worse) as starting on buprenorphine only and
switching to OX219 on day 3.

Patients will be screened and eligible patients will be randomized within 0-14 days after
screening, and followed for 28 days of treatment. Effectiveness of treatment will be
assessed, including:

- How long patients retain in treatment

- Assessment of opioid withdrawal symptoms

- Assessment of cravings for opioids

- Assessment of urine drug screens negative for opioids


Inclusion Criteria:

- Able to read, comprehend, and sign the informed consent form and willingly provide
written informed consent

- Prepared to engage in opioid replacement therapy and to abstain from opioid
utilization other than the study drug, and from other illicit drugs.

- Male or female, 18 to 65 years old, inclusive.

- Meet the criteria for opioid dependence as defined in the DSM-IV-TR, in the past 12
months.

- Have a BUP-negative urine drug screen and/or urine dipstick result before
randomization.

- Have a negative urine pregnancy test

- For females of childbearing potential: Using a reliable method of contraception
(e.g., hormonal, condom with spermicide, intrauterine device [IUD]) after the
screening visit and for the duration of the study.

- For participants receiving opioids for pain, clearance from their prescribing
physician to be withdrawn from their prescribed opioids.

- Generally good health as determined by the investigator

- Subjects should demonstrate at least mild withdrawal symptoms (defined as a COWS
score >9) at Day 1 predose.

Exclusion Criteria:

- Females who are pregnant or lactating, or planning to be pregnant during study.

- Any previous prescribed treatment with BUP monotherapy (e.g., generic BUP SL
tablets).

- Prescribed treatment with BUP or NAL within 90 days prior to start of treatment.

- Methadone patients with any daily dose over 30 mg during the past week and who
received the last dose of methadone less than 30 hours prior to start of treatment.

- Participants who are unwilling or unable to comply with the requirements of the
protocol

- Participants who are participating in any other clinical study in which medication(s)
are being delivered or who have used an investigational drug or device within the
last 30 days.

- Participants with any known allergy or sensitivity or intolerance to BUP, NAL, or any
related drug

- Participants who are on the staff, affiliated with, or a family member of the staff
personnel directly involved with this study.

- Participants with serious untreated Axis I DSM-IV-TR psychiatric comorbidity

- Tongue piercing or other piercings in the mouth, including lips and cheek.

- Participations with current or history of clinically significant medical disorder or
condition

- Subjects who are human immunodeficiency virus (HIV)-seropositive with a CD4+ count <
200 or active acquired immune deficiency syndrome (AIDS)

- Participants who have any Class III or IV congestive heart failure, symptomatic
myocardial ischemia, a history of long QT syndrome.

- Participants who are currently taking Class 1A antiarrhythmic medications or Class
III antiarrhythmic medications

- Participants who have uncontrolled hypertension or clinically significant ECG
abnormalities

- Participants who have a pulse oximetry ≤93% at screening, due to any medical reason.

- Subject has AST or ALT levels ≥3 X the upper limit of normal or total bilirubin or
creatinine ≥1.5 X ULN, on the screening laboratory assessments

- Participants with known significant liver disease.

- Participants who take any medication, nutraceutical, herbal product with known CYP3A4
inhibition or induction properties within 14 days of screening.

- Participants who are at suicidal risk
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