Condition category
Mental and Behavioural Disorders
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
06/04/2009
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 Duncan Raistrick

ORCID ID

Contact details

Addictions Unit
19 Springfield Mount
Woodhouse
Leeds
LS2 9NG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0120148502

Study information

Scientific title

Acronym

Study hypothesis

To investigate whether buprenorphine opiate detoxification regime can be considered to be at least as clinically effective as a lofexidine regime, which was taken at the reference treatment.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Mental and Behavioural Disorders: Drug addiction

Intervention

The study was a randomised controlled trial (RCT) using a non-inferiority approach. Non-inferiority is demonstrated if, within a 95% confidence interval, buprenorphine performs within a preset tolerance limit of clinically acceptable differences in outcomes, completion rates between the two treatments.

Individual ready for heroin detoxification were given information about the trial and invited to participate. Consenting participants were then randomised to one of the two treatments. Detoxification was undertaken in a specialist outpatient clinic according to pre-defined protocols. The detoxification procedure required that this was an open label trial. The primary outcome was whether or not an individual completed the detoxification. Completion of the planned detoxification was taken to be an objective marker of both the acceptability of the pharmacotherapy and also the effectiveness of the detoxification procedure in the clinic. Abstinence at one-month follow-up was taken as an indicator of overall treatment effectiveness and was used as a secondary outcome measure.

The difference in completion proportions between the two treatments was then tested to determine whether or not the treatments could be considered clinically equivalent. Data were also collected for individuals who declined randomisation and instead chose their treatment. Additional secondary outcome measures were substance use, dependence, psychological health, social satisfaction and treatment satisfaction.

Intervention type

Drug

Phase

Not Specified

Drug names

Buprenorphine, lofexidine

Primary outcome measures

The primary outcome was whether or not an individual completed the detoxification.

Secondary outcome measures

Abstinence at one-month follow-up was taken as an indicator of overall treatment effectiveness and was used as a secondary outcome measure.

Overall trial start date

01/05/2000

Overall trial end date

30/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Individual ready for heroin detoxification who agreed to take part in the trial.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2000

Recruitment end date

30/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addictions Unit
Leeds
LS2 9NG
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Leeds Mental Health Teaching NHS Trust (UK) NHS R&D Support Funding

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16367987

Publication citations

  1. Results

    Raistrick D, West D, Finnegan O, Thistlethwaite G, Brearley R, Banbery J, A comparison of buprenorphine and lofexidine for community opiate detoxification: results from a randomized controlled trial., Addiction, 2005, 100, 12, 1860-1867, doi: 10.1111/j.1360-0443.2005.01273.x.

Additional files

Editorial Notes