None listed
Conditions
Brief summary
Buprenorphine-Naloxone (BNX) sublingual film is the preferred preparation for buprenorphine substitution treatment of opioid dependence. However, the smallest dose available in the BNX film preparation is 2mg. Experience with buprenorphine has shown that some patients who wish to taper and cease buprenorphine find the transition from 2mg to zero difficult due to severity of withdrawal symptoms, and therefore continue in maintenance treatment (Winstock, Lintzeris, & Lea, 2011). In order to investigate these concerns we propose to use Temgesic sublingual tablets which are Buprenorphine only tablets however they are available in 200 microgram (0.2mg) tablets, and as such allow for smaller dose reductions than Subutex tablets which are only available at 400 microgram (0.4mg). This pilot study specifically aims to provide subjective and objective measures of withdrawal, when there is a 1mg reduction from 2mg of Temgesic sublingual tablets (SL), by using the measurements of withdrawal proposed below, in order to conduct a power analysis to determine the number of participants required for a larger pilot study.
Interventions
This study is an exploratory pilot study that aims to examine whether the subjective and objective measures of withdrawal proposed are sensitive enough to discriminate withdrawal, when there is a 0.2, 0.4, 0.6, 0.8 or 1mg reduction from 2mg of Buprenorphine only sublingual tablets (SL; under the tongue), by using the measurements of withdrawal proposed below, in order to provide data for a robust power analysis for a larger study. The trial design involves a randomised 1-way crossover design in
This study is an exploratory pilot study that aims to examine whether the subjective and objective measures of withdrawal proposed are sensitive enough to discriminate withdrawal, when there is a 0.2, 0.4, 0.6, 0.8 or 1mg reduction from 2mg of Buprenorphine only sublingual tablets (SL; under the tongue), by using the measurements of withdrawal proposed below, in order to provide data for a robust power analysis for a larger study. The trial design involves a randomised 1-way crossover design in three phases over a 21-day period once participants have been transferred from 2mg once daily BNX film to 2mg once daily of Buprenorphine only SL tablets: (1) Phase 1: a baseline phase of Buprenorphine only tablet treatment (2mg equivalent dose) (7 days) followed by (2) Phase 2: a double-blind treatment (experimental) phase (7 days) where participants dose will be reduced to a minimum of 1mg through a combination of active and placebo dosing; and, (3) Phase 3 (7 days): a stabilisation phase where participants will be returned to 2mg Buprenorphine only tablets. Participants will undergo each reduction and will therefore complete Phases 2 and 3 five times during the study (taking 13 weeks to complete). We will monitor adherence by daily saliva testing throughout the experimental phase.
Sponsors
Assoc Prof Robert Ali
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) Expressed desire to end BNX film treatment b) Currently on BNX film treatment (2mg/day) c) Aged greater than or equal to 18 years d) Urine test free of opioids in the previous month e) Enrolled in BNX film treatment for at least 90 days prior to the study f) Has not missed more than 2 doses per week for the previous month g) Negative pregnancy test h) Able to provide written informed consent
Exclusion criteria
i) Pregnancy; j) Participants who cannot fulfil the requirements of the protocol (e.g. requirements for daily attendance) or are in a situation that, in the opinion of the site investigator, may interfere with participation in the study (e.g. pending imprisonment); or k) Major physical or psychological condition or treatment, judged by clinical team to contraindicate study participation l) Dependence to other psychoactive substances that require detoxification, including heroin, amphetamines, cocaine, benzodiazepine and/or alcohol (except nicotine) m) Those who are participating or planning to participate (in the next month) in any other clinical study in which medication(s) are being delivered n) Those who are taking anticholinergic medications, anticonvulsants, tricyclic antidepressants, phenothiazines, stimulants and sympathomimetics.
Outcome results
None listed