An open label cross-over study of direct transfers between methadone and buprenorphine maintenance

An open label cross-over study of the effect of direct transfers between methadone and buprenorphine maintenance on sleep, cognitive, endocrine and cardio-respiratory function.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12608000039381

Enrollment

Registered

2008-01-23

Start date

2008-03-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project is designed to examine whether opiate subsititution on table doses of methadone or buprenorphine differentiall affect clinical outcomes (i.e. drug use), cognitive function (i.e. attention), endocirne function (i.e. libido), cardio-respiratory function (i.e. heart rate), sleep function (sleep activity) and driving skills.

Interventions

Thirty opioid maintenance patients who are seeking to switch between methadone and buprenorphine/naloxone will be tested pre and post transfer on a range of clinical outcomes including sleep function, cognitive function, endocrine function, cardio-respiratory function and driving performance. Methadone is a full opioid agonist with a usual daily maintainence dose of 30-80 mg taken orally. Buprenorphine is a partial opioid agonist taken sublingually up to a maximum of 32 mg. Doses vary accordi

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Stable methadone or buprenorphine treatment > 2 months, seeking to transfer to an alteernate opioid maintenance.

Exclusion criteria

Active or uncontrolled severe psychiatric illness or medical problems. No other current drug dependence or withdrawal iisues. Pregnancy.

Outcome results