Conditions: Opioid-Related Disorders
Keywords: Opioid dependence
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 382
Healthy volunteers: no

Brief summary:
This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone.

Detailed description:
Buprenorphine and naloxone soluble film was developed as an alternative dosage form to Suboxone (buprenorphine and naloxone) sublingual tablets and was evaluated for both sublingual and buccal administration. The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Suboxone (buprenorphine and naloxone) product:

* mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format.
* improvement in subject convenience and compliance by ensuring rapid disintegration.
* protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting.
* provision of a unit dose product format for hospital and institutional use.
* decreased product damage during shipping as compared to Suboxone tablets.

Arms:
arm 1: Buprenorphine/naloxone film strip administered sublingually arm 2: Buprenorphine/naloxone film strip administered buccally

Interventions: intervention 1: Buprenorphine/naloxone Film Strip intervention 2: Buprenorphine/naloxone Film Strip
Intervention descriptions: intervention 1: Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route intervention 2: Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route

Protocol document: