Skip to content

Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film

CompletedPhase 2NCT01871285
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The primary aim of this study is to determine if chronic pain subjects on around-the-clock opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely transitioned on to buprenorphine hydrochloride (HCl) buccal film at 50% of their MSE dose without inducing opioid withdrawal or reversing analgesic effects.

Study details

Official title
An Evaluation of the Tolerability of Switching Subjects on Chronic Around-the-Clock (ATC) Opioid Therapy to Buprenorphine HCl Buccal Film
Conditions
Interventions
Sponsor
BioDelivery Sciences International
Start date
2013-06
Primary completion
2014-07
Sex
All
Age range
from 18 Years to 60 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
3

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Written informed consent obtained prior to any study-related procedure being performed 2. Male or non-lactating female subjects 18 to 60 years of age at time of consent 3. Female subjects who are non-pregnant on the basis of screening serum pregnancy test and who are practicing abstinence or using a medically acceptable form of contraception (eg, intrauterine device, hormonal birth control, or double barrier method) or have been post-menopausal, biologically sterile, or surgically sterile (ie, hysterectomy, bilateral oophorectomy, or tubal ligation) for more than 1 year 4. Male subjects who are practicing abstinence, surgically sterile or are using a medically acceptable form of contraception 5. Subjects with a ≥6 months history of chronic pain (including peripheral neuropathic pain) requiring ATC opioid therapy with ≥80 mg but ≤220 mg MSE per day for at least 28 days 6. Receiving one of the following opioids ATC for ≥28 days: (i) Morphine Sulfate; (ii) Oxycodone hydrochloride 7. Displays signs and symptoms of withdrawal (ie, COWS score ≥5) within 5 minutes following naloxone challenge 8. Able to understand the study procedures, complete the assessment scales, and communicate meaningfully with study personnel 9. Stable health, as determined by the Principal Investigator, on the basis of medical history, physical examination, and screening laboratory results Exclusion Criteria: 1. Inability to meet study participation requirements, including two 2-night stays with pharmacokinetic sampling 2. A history or current evidence of clinically significant pulmonary (eg, asthma, chronic obstructive pulmonary disease, cor pulmonale or severe bronchial asthma ), gastrointestinal, hepatic, renal, hematologic, immunologic, endocrine, neurologic, oncologic or psychiatric disorder or any other condition, including evidence of abnormalities on physical examination, abnormal vital signs, electrocardiogram (ECG), or clinical laboratory values which in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results 3. Supine systolic blood pressure \>180 mm Hg or \<90 mm Hg or diastolic blood pressure \> 105 mm Hg or \<50 mm Hg at screening (may be repeated once) 4. COWS score greater than 4 prior to the screening naloxone challenge 5. Aspartate aminotransferase or alanine aminotransferase \>3 times the upper limits of normal or serum creatinine \>1.9 mg/dL at Screening, or any laboratory abnormalit…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01871285