The acceptability, safety and tolerability of combined methadone-naloxone - Intra muscular (IM) challenge

Does intra muscular methadone nalxone in a 50:1 ratio precipitate withdrawal among opioid dependent individuals

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000058471

Enrollment

Registered

2007-01-18

Start date

2006-08-24

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

The primary purpose of this study is to test whether intramuscualr methadone-naloxone in a 50:1 ratio precipitates withdrawal in opioid dependent individuals.

Interventions

Participants receive 3 injections: IM Saline adminsitered at baseline, 10mg/.2mg methadone naloxone administered IM at 20 minutes and if no objective signs of withdrawal are observed at 50 minutes, a further 20mg/.4mg methadone naloxone administered IM.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Opioid dependent; in treatment for >2mths; on methadone dose of >20mg; stabilised on current dose for >4 weeks; Able to provide voluntary informed consent.

Exclusion criteria

Considered unwilling, unable or unlikely to comply with the study protocol;Lactating and pregnant women; Active psychotic illness.

Outcome results