None listed
Conditions
Brief summary
The purpose of this study was to evaluate the novel soluble sublingual film dosage form of Suboxone(R) in comparison to the existing tablet dosage form. It was hypothesised that participants would prefer the novel dosage form to the existing tablet due to its ease of use and the added convenience it provided.
Interventions
Pre-randomisation
All participants receive their usual daily dose of Suboxone(R) as soluble buprenorphine/naloxone tablets (7 days open label)
Post-randomisation
Randomised to one of two arms (intervention or comparator).
Arm 1: Soluble sublingual buprenorphine/naloxone films at their usual daily dose (10 days double-blind double dummy placebo controlled followed by 14 days open label)
NB. The placebo for Arm 1 were matched soluble sublingual inactive films. If patients were randomised to Arm
Pre-randomisation All participants receive their usual daily dose of Suboxone(R) as soluble buprenorphine/naloxone tablets (7 days open label) Post-randomisation Randomised to one of two arms (intervention or comparator). Arm 1: Soluble sublingual buprenorphine/naloxone films at their usual daily dose (10 days double-blind double dummy placebo controlled followed by 14 days open label) NB. The placebo for Arm 1 were matched soluble sublingual inactive films. If patients were randomised to Arm 1, they would receive both film and tablets in the double-blind phase, with the film being active and the tablets placebo. Conversely, if randomised to Arm 2, they would receive both film and tablets in the double-blind phase, with the tablets being active and the film placebo. Patients received only ONE active preparation at all times.
Sponsors
Associate Professor Nicholas Lintzeris
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) Opioid dependence according to the DSM IV-TR criteria, b) Buprenorphine or buprenorphine/naloxone treatment (4-32mg/day) for at least 3 months c) Stable Suboxone dose for at least 30 days.
Exclusion criteria
a) Dependence to other psychoactive substances b) Patients with concomitant severe, untreated medical or psychiatric conditions c) Patients who cannot fulfil the requirements of the protocol (e.g. requirements for attendance)
Outcome results
None listed