Overview

This trial is active, not recruiting.

Condition opioid dependence, on agonist therapy
Treatment buprenorphine/naloxone
Phase phase 4
Sponsor Orexo AB
Start date July 2013
End date September 2014
Trial size 700 participants
Trial identifier NCT01903005, OX219-008

Summary

The purpose of this study is to assess treatment efficacy and adherence of OX219 (Buprenorphine/Naloxone).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Week 1-24 OX219 buprenorphine/naloxone sublingual tablet (open-label)
buprenorphine/naloxone
OX219 buprenorphine/naloxone sublingual tablets

Primary Outcomes

Measure
To assess the safety and tolerability of OX219(AE)
time frame: Participants will be followed for the duration of an expected average of 24 weeks
To assess the safety and tolerability of OX219 (Vital Signs)
time frame: Participants will be followed for the duration of an expected average of 24 weeks
To assess the safety and tolerability of OX219 (Safety laboratory tests)
time frame: Participants will be followed for the duration of an expected average of 24 weeks
To assess the safety and tolerability of OX219 (C-SSRS)
time frame: Participants will be followed for the duration of an expected average of 24 weeks
To assess the safety and tolerability of OX219 (Local tolerability assessments)
time frame: Participants will be followed for the duration of an expected average of 24 weeks

Secondary Outcomes

Measure
Clinical Opiate Withdrawal Scale score (COWS)
time frame: Participants will be followed for the duration of an expected average of 24 weeks
Subjective Opiate Withdrawal Scale score (SOWS)
time frame: Participants will be followed for the duration of an expected average of 24 weeks
Craving VAS
time frame: Participants will be followed for the duration of an expected average of 24 weeks
Urine drug screen (UDS) and/or urine dipstick
time frame: Participants will be followed for the duration of an expected average of 24 weeks
Self report of substance use/opioid use
time frame: Participants will be followed for the duration of an expected average of 24 weeks
Addiction Severity Index - Lite (ASI-Lite)
time frame: Participants will be followed for the duration of an expected average of 24 weeks
Patient Global Impression of Improvement (PGI-I)
time frame: Participants will be followed for the duration of an expected average of 24 weeks
Clinical Global Impression of Severity (CGI-S)
time frame: Participants will be followed for the duration of an expected average of 24 weeks
Clinical Global Impression of Improvement (CGI-I)
time frame: Participants will be followed for the duration of an expected average of 24 weeks
To evaluate retention in treatment during study period
time frame: Participants will be followed for the duration of an expected average of 24 weeks
Pain Numerical rating scale (NRS)
time frame: Participants will be followed for the duration of an expected average of 24 weeks
Patient Assessment of Constipation Symptoms (PAC-SYM)
time frame: Participants will be followed for the duration of an expected average of 24 weeks
SF-36 ratings
time frame: Participants will be followed for the duration of an expected average of 24 weeks
Work productivity/activity impairment: Specific health problem questionnaire (WPAI:SHP)
time frame: Participants will be followed for the duration of an expected average of 24 weeks
To assess treatment compliance
time frame: Participants will be followed for the duration of an expected average of 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion criteria 1. Signed informed consent form (ICF). 2. Patient has completed the OX219-006 or the OX219-007 study. 3. Female subjects of child bearing potential who use a reliable method of contraception (e.g. hormonal, condom with spermicide, IUD) during the previous OX219-006 or OX219-007 studies and during the duration of the OX219-008 study. Females of nonchild bearing potential who are either surgically sterile (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, tubal ligation), or post-menopausal as defined by being at least 50 years of age and having had an absence of menses for at least 2 years are also allowed. Exclusion criteria 1. Females who are pregnant (positive pregnancy test) or lactating, or planning to be pregnant during study. 2. Participants who are unwilling or unable to comply with the requirements of the protocol (e.g., pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study. 3. Participants who are participating in any other clinical study in which medication(s) are being delivered. 4. Participants with any known allergy or sensitivity or intolerance to BUP, NAL or any related drug, or history of any drug hypersensitivity or intolerance which in the opinion of the investigator, would compromise the safety of the subject or the study. 5. Participations with a contra-indicated serious medical condition. 6. Participants who are at suicidal risk as determined by meeting any of the following: history of suicidal ideation ≤ 3 months prior to baseline with a score of 4 (intent to act) or 5 (specify plan and intent) on the C-SSRS; history of suicidal behavior (actual attempt, interrupted attempt, aborted attempt, and/or preparatory acts/behavior) on the C-SSRS.

Additional Information

Official title A Multi-center, Open-label, 24-week, Follow-up Study to Assess Safety, Efficacy and Treatment Adherence for Maintenance Treatment of Opioid Dependence With OX219
Principal investigator Kent Hoffman
Description A multi-center-, open-label-, uncontrolled-, single armed-, 24-week, follow-up study to assess safety, efficacy and treatment adherence for maintenance treatment of opioid dependence with OX219. Only patients from studies; OX219-006 or OX219-007 is permitted to participate Total study treatment 24 weeks.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Orexo AB.