Condition category
Mental and Behavioural Disorders
Date applied
17/09/2007
Date assigned
04/03/2008
Last edited
04/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Outi Kuikanmäki

ORCID ID

Contact details

Munkkisaarenkatu 16
Helsinki
01500
Finland
outi.kuikanmaki@hdl.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HDL07-01

Study information

Scientific title

Acronym

BUNXLOW

Study hypothesis

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

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)

Study design

Randomised, active controlled, three-arm, parallel group, single centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Buprenorphine-naloxone, iofexidine

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

24/09/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 patients

Participant 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

Recruitment start date

24/09/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Finland

Trial participating centre

Munkkisaarenkatu 16
Helsinki
01500
Finland

Sponsor information

Organisation

Helsinki Deaconess Institute (Finland)

Sponsor details

c/o Outi Kuikanmäki
Munkkisaarenkatu 16
Helsinki
01500
Finland
outi.kuikanmaki@hdl.fi

Sponsor type

Hospital/treatment centre

Website

http://www.hdl.fi

Funders

Funder type

Research organisation

Funder name

Academy of Finland (Finland)

Alternative name(s)

Academy of Finland

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Finland

Funder name

National Public Health Institute (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Helsinki Deaconess Institute (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes