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Opiate detoxification study
ISRCTN ISRCTN14951861
DOI 10.1186/ISRCTN14951861
ClinicalTrials.gov identifier
EudraCT number
Public title Opiate detoxification study
Scientific title
Acronym N/A
Serial number at source N0120148502
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.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Mental and Behavioural Disorders: Drug addiction
Participants - inclusion criteria Individual ready for heroin detoxification who agreed to take part in the trial.
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/05/2000
Anticipated end date 30/09/2004
Status of trial Completed
Patient information material
Target number of participants Not provided at time of registration
Interventions 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.
Primary outcome measure(s) The primary outcome was whether or not an individual completed the detoxification.
Secondary outcome measure(s) Abstinence at one-month follow-up was taken as an indicator of overall treatment effectiveness and was used as a secondary outcome measure.
Sources of funding Leeds Mental Health Teaching NHS Trust (UK) NHS R&D Support Funding
Trial website
Publications 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16367987
Contact name Dr  Duncan  Raistrick
  Address Addictions Unit
19 Springfield Mount
Woodhouse
  City/town Leeds
  Zip/Postcode LS2 9NG
  Country United Kingdom
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health
  Address The Department of Health, Richmond House, 79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 29/09/2006
Last edited 06/04/2009
Date ISRCTN assigned 29/09/2006
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