WHOS Coming Off Buprenorphine: understanding the experience of withdrawing from buprenorphine medication in the treatment of opioid dependence

Not Applicable

Recruiting

• Conditions: Opioid Dependence (Opioid Use Disorder); Opioid Withdrawal Syndrome; Mental Health - Addiction

• Registration Number: ACTRN12621001011875
• Lead Sponsor: South East Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-02
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

In buprenorphine treatment for indication of opioid dependence, and willing to discontinue buprenorphine treatment in a long-term residential rehabilitation setting.
For participants in depot buprenorphine arm:
1.In buprenorphine treatment for at least 8 weeks prior to projected admission date
2.In treatment with Buvidal Monthly (64, 96 or 128mg) for at least 1 dose (administered 4±1 weeks), or Buvidal Weekly (16mg, 24mg or 32mg) for at least 4 doses (administered 7±2 days) prior to projected admission date.

For participants in SL buprenorphine arm:
1.In SL buprenorphine treatment for at least 8 weeks prior to projected admission date.
2.On a SL BPN dose of no greater than 24 mg daily in the week prior to admission

Exclusion Criteria

1.Likely to experience a withdrawal syndrome from another substance, including alcohol, BZDs, cannabis, opioids and stimulants. Operationalized as using substances on 4 days or more (on average) in the 4 weeks preceding the admission (ATOP Substance Use section - alcohol at 80gm per day; cannabis; benzodiazepines; amphetamine type substances, heroin or prescription opioids),
2.Active severe medical (e.g. unstable mental health, chronic pain) or social conditions (e.g. impending court case with likely custodial sentence) that mitigate against an admission for withdrawal from opioid agonist treatment .
3.Significant changes in use of other psychoactive medications in the 28 days prior to admission (e.g. antidepressant, anti-convulsant, antipsychotic medications). Exclusions include clients seeking to initiate, cease or substantially change their dose in the 28 days prior to admission, or during the admission.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the Clinical Opiate Withdrawal Scale (COWS) (Wesson and Ling 2003), an 11-item instrument that includes both subjective symptoms and objective signs of opiate withdrawal, and administered by trained nursing staff . [Data collected at baseline (entry) and at weekly intervals over course of 16-week admission];Subjective Opiate Withdrawal Scale (Handelsman et al 1987) measures the severity of subjective symptoms of opiate withdrawal using a 16-item checklist, and self-completed by participants. [Measured at baseline and at weekly intervals over the 16-week admission. ];Objective Opiate Withdrawal Scale (OOWS) (Handelsman et al 1987), is a 13-item scale that assesses signs of opiate withdrawal, and completed by training nursing staff. [Administered at baseline and at weekly intervals over the 16 week admission. ]