Evaluation of Instruments and Procedures Used to Measure Opioid Withdrawal in Opioid Dependent Participants Who are Seeking to Discontinue Methadone Opioid Substitution Treatment (OST)

Not Applicable

Completed

• Conditions: Opioid Dependency; Mental Health - Addiction

• Registration Number: ACTRN12613000539730
• Lead Sponsor: DemeRx Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

The main inclusion criteria are opioid dependent male and female adults (18-55 years) who provide written consent and are on stable doses of methadone through the OST programme. Participants cannot have any other major illnesses or disorders and must be willing to comply with the restrictions of the study.

Exclusion Criteria

Exclusion criteria include current treatment for hepatitis C; HIV positive; DSM IV Axis I diagnosis of psychotic disorders; specified excluded concomitant medications; DSM IV criteria for dependence on substances other than opioids, caffeine, and/or nicotine.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The objective of this study isto evaluate the instruments and procedures to be used in a subsequent study of the safety and tolerability of noribogaine in opioid dependent Participants. <br><br>Primary Endpoint: Evaluate the usefulness of SOWS/OOWS and COWS to define withdrawal[SOWS/OOWS and COWS Assessments will be done at the initial screening between Day -28 to Day -9, Day -8 pre methadone dose and 2 and 4 hours post dosing, Day-7 at pre CR morphine dose, 2, 4 and 12 hours post dosing, Day -6 to Day -3 prior to the 8AM CR morphine dosing, Day -2 and -1 prior to morphine dosing at 8AM and 5PM, Day 1 baseline and at 1, 2, 4, 6, 8 and 12, 24, 28, 32, 36 and 48 hours after holding the 8AM morphine dose and at Visit 1 (one week after discharge from the Clinical Site at Day 3). ]