Short versus long buprenorphine-naloxone treatment in intravenous buprenorphine withdrawal: a randomised controlled trial

ISRCTN	ISRCTN72781592
DOI	https://doi.org/10.1186/ISRCTN72781592
Protocol serial number	HDL07-01
Sponsor	Helsinki Deaconess Institute (Finland)
Funders	Academy of Finland (Finland), National Public Health Institute (Finland), Helsinki Deaconess Institute (Finland)

Submission date: 17/09/2007
Registration date: 04/03/2008
Last edited: 04/03/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Outi Kuikanmäki
Scientific

Munkkisaarenkatu 16
Helsinki
01500
Finland

Email	outi.kuikanmaki@hdl.fi

Study information

Primary study design	Interventional
Study design	Randomised, active controlled, three-arm, parallel group, single centre trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	BUNXLOW
Study objectives	1. To investigate the effectiveness of buprenorphine-naloxone compared with treatment as usual (lofexidine) in withdrawal of intravenous buprenorphine dependence 2. To determine whether a longer regime is more effective than a shorter one
Ethics approval(s)	Ethics approval received from: 1. The Ethics Committee for Pediatrics, Adolescent Medicine and Psychiatry/Hospital District of Helsinki and Uusimaa on the 15th May 2007; amendment on the form of informed consent was approved 19th June 2007 (ref: 148/E7/2007) 2. The National Agency for Medicines approval on the 22nd August 2007 (ref: 96/2007)
Health condition(s) or problem(s) studied	Intravenous misuse of buprenorphine
Intervention	1. Short buprenorphine-naloxone (Bu-nx) arm: for 9 days: Day 1: 8 mg Days 2 - 3: 8 - 16 mg (dose according to clinical assessment) Days 4 - 5: 8 mg Days 6 - 7: 4 mg Days 8 - 9: 2 mg 2. Long buprenorphine-naloxone arm: for 25 days: Day 1: 8 mg Days 2 - 3: 8 - 16 mg (dose according to clinical assessment) Days 4 - 9: 8 mg Days 10 - 12: 6 mg Days 13 - 16: 4 mg Days 17 - 20: 2 mg Days 21 - 25: 1 mg 3. Lofexidine arm: lofexidine according to clinical assessment, maximum dose 2.4 mg/d divided into two to three doses, maximum duration 21 days In all arms, the intended withdrawal duration (in-patient treatment) is 28 +/- 7 days, and the follow-up period is up to six months after that.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Buprenorphine-naloxone, iofexidine
Primary outcome measure(s)	1. Completion of withdrawal 2. Retention in rehabilitation for one month 3. Abstinence at one month after withdrawal 4. Abstinence at six months after withdrawal
Key secondary outcome measure(s)	1. The extent of withdrawal symptoms experienced, recorded every day during withdrawal 2. The amount of additional medication needed, recorded every day during withdrawal 3. Whether the patient begins naltrexone medication, patients will be offered an opportunity to begin naltrexone three days before finishing withdrawal 4. Patient satisfaction, measured at the last day of withdrawal, whether at the intended finishing date, or at premature termination of withdrawal. Satisfaction will be measured by a self-made questionnaire of seven questions concerning the satisfaction with the medication, the length of medication, the additional medication, the length of withdrawal, the staff, the opportunity of beginning naltrexone and the overall satisfaction with the withdrawal treatment. Answers will be recorded with a five-grade scale
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Opiate dependence (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition [DSM IV]) 2. Current misuse of buprenorphine intravenously (mimimun 3 mg/day) (use confirmed by urinalysis) 3. Willingness to participate in withdrawal in the treatment centre and in rehabilitation afterwards 4. Aged between 18 and 50
Key exclusion criteria	1. Other than buprenorphine as the primary drug of misuse 2. Misuse of other opiates then buprenorphine during the last week (confirmed by urinalysis) 3. Opiate maintenance therapy 4. Psychotic symptoms at recruitment 5. Psychiatric or somatic disease or symptoms that may require hospitalisation at near future 6. Salient increase in alanine aminotransferase (ALAT) 7. Pregnancy 8. Allergy to lofexidine, buprenorphine or naloxone 9. Former participation to the same study 10. Concurrent participation to other intervention studies 11. Native language other than Finnish
Date of first enrolment	24/09/2007
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Finland

Study participating centre

Munkkisaarenkatu 16

Helsinki
01500
Finland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan