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ISRCTN
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ISRCTN14951861
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ClinicalTrials.gov identifier
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Public title
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Opiate detoxification study
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0120148502
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mental and Behavioural Disorders: Drug addiction
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Participants - inclusion criteria
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Individual ready for heroin detoxification who agreed to take part in the trial.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/05/2000
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Anticipated end date
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30/09/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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.
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Primary outcome measure(s)
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The primary outcome was whether or not an individual completed the detoxification.
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Secondary outcome measure(s)
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Abstinence at one-month follow-up was taken as an indicator of overall treatment effectiveness and was used as a secondary outcome measure.
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Sources of funding
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Leeds Mental Health Teaching NHS Trust (UK) NHS R&D Support Funding
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16367987
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Contact name
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Dr
Duncan
Raistrick
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Address
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Addictions Unit
19 Springfield Mount
Woodhouse
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City/town
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Leeds
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Zip/Postcode
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LS2 9NG
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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06/04/2009
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Date ISRCTN assigned
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29/09/2006
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