None listed
Conditions
Brief summary
The introduction of long acting depot (modified release) buprenorphine subcutaneous injections in recent years is a significant addition to the medication options for the treatment of opioid dependence. These medications are long acting and enable 'once a month' doses rather than daily medication such as sublingual buprenorphine - which are often associated with inconvenience and cost for patients and health services. However little is known about the nature of the withdrawal syndrome that occurs if patients discontinue depot buprenorphine medication. The aim of this study is to describe the profile of withdrawal signs and symptoms in participants discontinuing opioid treatment with a 4-weekly depot buprenorphine formulation, and to compare against the withdrawal profile of a parallel group of participants discontinuing opioid treatment using sublingual buprenorphine. Participants will be monitored over a 16-week admission in a residential rehabilitation unit that assists clients withdrawing from opioid agonist treatment; and participants will withdraw using the buprenorphine formulation they are prescribed prior to the admission (a non-randomised comparison group). The main outcome is opiate withdrawal severity (subjective and objective features) over the course of the admission, with secondary outcomes of cravings, adverse events, general heath, sleep measures and patient experience. .
Interventions
Participants will be admitted into a 16-week residential rehabilitation program, during which they will undertake withdrawal from their routinely prescribed buprenorphine medication.
There are two groups of participants - those withdrawing from depot buprenorphine, and those withdrawing from sublingual buprenorphine (determined by the medication prescribed in the community prior to admission - i.e., self-selected comparison groups). It is an open-label study with participants and treatment pro
Participants will be admitted into a 16-week residential rehabilitation program, during which they will undertake withdrawal from their routinely prescribed buprenorphine medication. There are two groups of participants - those withdrawing from depot buprenorphine, and those withdrawing from sublingual buprenorphine (determined by the medication prescribed in the community prior to admission - i.e., self-selected comparison groups). It is an open-label study with participants and treatment providers aware of the medication being used. Arm 1: Participants in the depot buprenorphine group will recieve one dose of 64mg modified release Subcutaneous depot buprenorphine injection (Buvidal Monthly) administered in the first week of treatment in the rehabilitation program. No further doses of buprenorphine will be administered to the participants in the depot buprenorphine arm. Arm 2: Doses for participants in the sublingual buprenorphine group will be individualsed according to the participant's usual dose at entry into the program (commencing from a maximum of 24mg daily dose) and undertake a gradual dose taper with weekly dose reductions of 2-4mg per week to 0mg over the first 8 weeks of the program - with flexibility of up to a 2 week extension (ie reaching zero mg by week 10), determined by each participant in consultation with the study medical officer. Sublingual buprenorphine is supervised by nursing staff, and administered once a day (mornings). All medications are supervised in the residential unit, and adherence to medications will be documented by review of medication charts. All participants (both arms) will undergo routine psychosocial and group programs and activities of the residential service during the 16 week admission. These occupy approximately 6 hours a day and consist of health oriented psychoeducation, life skills training, exercise program, vocational activities (e.g. computer skills, literacy skills), relapse prevention counselling interventions, together with 'house meetings' and recreational activities. These services are delivered by mental health trained nurses, allied health and peer workers.
Sponsors
South East Sydney Local Health District
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Outcome results
None listed