None listed
Conditions
Brief summary
The clinical trial would compare heroin use in a group of patients randomly allocated to receive unsupervised dosing with buprenorphine-naloxone to a group of patients remaining on wait list for a 12 week period (when this group would then be offered substitution treatment). The study will also assess adverse events that may be related to providing unsupervised dosing with buprenorphine-naloxone.
Interventions
Patients randomised to the treatment group will receive daily buprenorphine naloxone for a period of 3 months administered as tablets of Suboxone delviered sublingually. During week 1 of dosing, the daily dose will be escalated from 4mg up to 16mg per day and tolerability to the dose will be determined, The maximum tolerable daily dose level will then be given for the duration of the treatment period. Dose tolerability will also be continually reviewed and doses modfied as required during this
Patients randomised to the treatment group will receive daily buprenorphine naloxone for a period of 3 months administered as tablets of Suboxone delviered sublingually. During week 1 of dosing, the daily dose will be escalated from 4mg up to 16mg per day and tolerability to the dose will be determined, The maximum tolerable daily dose level will then be given for the duration of the treatment period. Dose tolerability will also be continually reviewed and doses modfied as required during this period. Half of the initial dose of Suboxone tablets on the first day of treatment will be delivered to the patient in the clinic. For the remainder of the treatment period patients will be supplied with enough Suboxone tablets to enable them to self administer their own daily doses for the following week. At the commencement of each week during the treatment period patients will return to the clinic and be reviewed and receive enough take home doses for the following week of treatment.
Sponsors
Hunter New England Area Health Service, Drug and Alcohol Clinical Services
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnostic and Statistical manual of Mental Disorders, Fourth Edition (DSM IV) diagnosis of heroin dependence disorder. Recent heroin use (at least 20 days in the last month. Stable accomodation within the local geographical area. If female, willing to use contraception during the trial.
Exclusion criteria
Current pregnancy or breat feeding. Children under 16 years at home with current Department of Community Services(DOCS) involvement. Pending court hearings with a risk of custodial sentence. Current DSMIV substance dependence to alcohol, benzodiazepines, amphetamines or cocaine. Any Opiate Substitution Thearpy (OST) in the previous 4 weeks or more than 2 weeks consecutive OST in the previous 12 weeks. Co-existing major medical or psychiatiric condistions where immediate OST and / or otehr treaments are warranted.
Outcome results
None listed